Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 5:22 PM
Study NCT ID:
NCT00048568
Status:
COMPLETED
Last Update Posted:
2011-12-05
First Post:
2002-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol Myers-Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ABA + MTX OL', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.', 'otherNumAtRisk': 539, 'otherNumAffected': 466, 'seriousNumAtRisk': 539, 'seriousNumAffected': 215}, {'id': 'EG001', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.', 'otherNumAtRisk': 433, 'otherNumAffected': 320, 'seriousNumAtRisk': 433, 'seriousNumAffected': 68}, {'id': 'EG002', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.', 'otherNumAtRisk': 219, 'otherNumAffected': 144, 'seriousNumAtRisk': 219, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 131}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'TENDONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RHINITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'STRABISMUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VITREOUS DETACHMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ARTERIOGRAM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LABORATORY TEST ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ELECTROCARDIOGRAM ST SEGMENT ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIOGENIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYOCARDIAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SUPRAVENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ATRIOVENTRICULAR BLOCK COMPLETE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 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connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SOFT TISSUE NECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OSTEOPOROTIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SPINAL COLUMN STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SYSTEMIC LUPUS ERYTHEMATOSUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ATELECTASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SLEEP APNOEA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'TONSILLAR INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INTERSTITIAL LUNG DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'IMPAIRED HEALING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HERNIA OBSTRUCTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MULTI-ORGAN FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LEIOMYOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LUNG NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC MYXOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'THYROID NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'UTERINE LEIOMYOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ENDOMETRIAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'METASTATIC NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BENIGN BREAST NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FIBROADENOMA OF BREAST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LUNG NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYELODYSPLASTIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NEUROENDOCRINE CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GASTROINTESTINAL NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MALIGNANT MELANOMA IN SITU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ACUTE LYMPHOCYTIC LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BRONCHIOLOALVEOLAR CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LYMPHOPROLIFERATIVE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'METASTATIC MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SQUAMOUS CELL CARCINOMA OF SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.2', 'ciLowerLimit': '19.8', 'ciUpperLimit': '36.7', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response.', 'groupDescription': 'The study had a 99% power to detect a difference of 20% in ACR 20 between the 2 groups at the 5% level.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 169', 'description': 'ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.4', 'ciLowerLimit': '15.9', 'ciUpperLimit': '32.9', 'pValueComment': 'Based on the hierarchical testing procedure for the co-primary measures, the study had 98% power to detect 18% difference in HAQ response rate between the two arms at the 5% level.', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving HAQ response at Day 365.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'This model includes treatment as the main factor and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'BL', 'categories': [{'measurements': [{'value': '21.68', 'spread': '18.07', 'groupId': 'OG000'}, {'value': '21.83', 'spread': '18.63', 'groupId': 'OG001'}]}]}, {'title': 'Mean Change From BL', 'categories': [{'measurements': [{'value': '0.63', 'spread': '1.77', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.02'}, {'value': '1.14', 'spread': '2.81', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.27'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Nonparametric ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The rank of the change from baseline=dependent variable, treatment=the main factor, rank of baseline value as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the compliance issues of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Tender Joints and Swollen Joints at DB BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed by weight with participants weighing \\< 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Tender Joints', 'categories': [{'measurements': [{'value': '31.0', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '32.3', 'spread': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Swollen Joints', 'categories': [{'measurements': [{'value': '21.4', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0)', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants in the DB period.'}, {'type': 'SECONDARY', 'title': 'Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed by weight with participants weighing \\< 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Participant Physical Pain Assessment', 'categories': [{'measurements': [{'value': '63.3', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '65.9', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'Participant Global Assessment', 'categories': [{'measurements': [{'value': '62.7', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '62.8', 'spread': '21.6', 'groupId': 'OG001'}]}]}, {'title': 'Physician Global Assessment', 'categories': [{'measurements': [{'value': '68.0', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '67.4', 'spread': '17.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0)', 'description': 'Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants in the DB period.'}, {'type': 'SECONDARY', 'title': 'BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'RF Negative', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'RF Positive', 'categories': [{'measurements': [{'value': '312', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BL (Day 365)', 'description': 'This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was \\> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the DB period).'}, {'type': 'SECONDARY', 'title': 'ACR 20 Responders at Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.4', 'ciLowerLimit': '25.1', 'ciUpperLimit': '41.7', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response at Day 365.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365', 'description': 'ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'ACR 20 Responders in the Double-Blind (DB) Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 15', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Day 225', 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'categories': [{'measurements': [{'value': '312', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Day 365', 'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'ACR 50 Responders at Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.0', 'ciLowerLimit': '15.0', 'ciUpperLimit': '31.1', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 169.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 169', 'description': 'ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'ACR 50 Responders at Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.1', 'ciLowerLimit': '21.8', 'ciUpperLimit': '38.5', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 365.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365', 'description': 'ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'ACR 50 Responders in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 15', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Day 225', 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Day 365', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'ACR 70 Responders at Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.3', 'ciLowerLimit': '7.0', 'ciUpperLimit': '19.5', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA + MTX and MTX + PLA in the proportion of participants achieving ACR 70 response at Day 169.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 169', 'description': 'ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'ACR 70 Responders at Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.7', 'ciLowerLimit': '15.6', 'ciUpperLimit': '29.8', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365', 'description': 'ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'ACR 70 Responders in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 15', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Day 225', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Day 365', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Major Clinical Response By Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.3', 'ciLowerLimit': '7.3', 'ciUpperLimit': '17.2', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving MCR.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.', 'description': 'A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'BL (Day 0) for Day 169 Cohort (n=366, 179)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '6.84', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 169 Cohort (n=366, 179)', 'categories': [{'measurements': [{'value': '4.34', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 365 Cohort (n=375, 183)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 365 Cohort (n=375, 183)', 'categories': [{'measurements': [{'value': '3.97', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '5.36', 'spread': '1.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference on Day 169', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '-0.91', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA on Day 169.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference on Day 365', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.39', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '-1.16', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA on Day 365.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365, Day 169, Day 365', 'description': 'The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\\>5.1); low (≤3.2); remission (\\<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuations Due to SAEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': '378', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued Due to AEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365', 'description': 'AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated subjects in the DB period.'}, {'type': 'SECONDARY', 'title': 'Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Baseline Mean JSN', 'categories': [{'measurements': [{'value': '22.79', 'spread': '20.16', 'groupId': 'OG000'}, {'value': '23.02', 'spread': '20.36', 'groupId': 'OG001'}]}]}, {'title': 'Mean Change From Baseline JSN Day 365', 'categories': [{'measurements': [{'value': '0.58', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '2.58', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Mean TS', 'categories': [{'measurements': [{'value': '44.47', 'spread': '37.33', 'groupId': 'OG000'}, {'value': '44.85', 'spread': '37.72', 'groupId': 'OG001'}]}]}, {'title': 'Mean Change From Baseline TS Day 365', 'categories': [{'measurements': [{'value': '1.21', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '2.32', 'spread': '5.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'BL (Day 0) for Day 169 Cohort (n= 416, 207)', 'categories': [{'measurements': [{'value': '30.49', 'spread': '7.18', 'groupId': 'OG000'}, {'value': '30.61', 'spread': '7.42', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 365 Cohort (n=417, 207)', 'categories': [{'measurements': [{'value': '30.51', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '30.62', 'spread': '7.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 169 (n=416, 207)', 'categories': [{'measurements': [{'value': '8.82', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=417, 207)', 'categories': [{'measurements': [{'value': '9.12', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '4.97', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference at Day 169', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.06', 'ciLowerLimit': '2.64', 'ciUpperLimit': '5.57', 'groupDescription': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference at Day 365', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.15', 'ciLowerLimit': '2.69', 'ciUpperLimit': '5.62', 'groupDescription': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Participants in the DB Period Achieving an Extended Major Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '2.4', 'ciUpperLimit': '9.0', 'estimateComment': 'Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving extended MCR.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365', 'description': 'An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'BL (Day 0) CRP for Day 169 Cohort (n=418, 211)', 'categories': [{'measurements': [{'value': '6.37', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '6.36', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) ESR for Day 169 Cohort (n=418, 211)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '6.84', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) CRP for Day 365 Cohort (n=424, 212)', 'categories': [{'measurements': [{'value': '6.38', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) ESR for Day 365 Cohort (n=424, 212)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'mg / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'DAS-28 CRP Day 169 (n=418, 211)', 'categories': [{'measurements': [{'value': '-2.38', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'DAS-28 ESR Day 169 (n=418, 211)', 'categories': [{'measurements': [{'value': '-2.48', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'DAS-28 CRP Day 365 (n=424, 212)', 'categories': [{'measurements': [{'value': '-2.71', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'DAS-28 ESR Day 365 (n=424, 212)', 'categories': [{'measurements': [{'value': '-2.85', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.46', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'unitOfMeasure': 'mg / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the closure of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 169 (n=370, 171)', 'categories': [{'measurements': [{'value': '1776.0', 'spread': '946.5', 'groupId': 'OG000'}, {'value': '1603.0', 'spread': '933.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=235, 106)', 'categories': [{'measurements': [{'value': '1674.0', 'spread': '835.1', 'groupId': 'OG000'}, {'value': '1601.0', 'spread': '1076.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.', 'unitOfMeasure': 'mg / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated subjects in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 169 (n=370, 171)', 'categories': [{'measurements': [{'value': '-519.00', 'spread': '23.72', 'groupId': 'OG000'}, {'value': '-85.50', 'spread': '32.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=235, 106)', 'categories': [{'measurements': [{'value': '-562.00', 'spread': '40.82', 'groupId': 'OG000'}, {'value': '-290.00', 'spread': '87.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.', 'unitOfMeasure': 'mg / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated subjects in the DB period.'}, {'type': 'SECONDARY', 'title': 'ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'BL (Day 0) for Day 15 Cohort (n=416, 210)', 'categories': [{'measurements': [{'value': '25.19', 'spread': '14.62', 'groupId': 'OG000'}, {'value': '27.93', 'spread': '14.27', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 29 Cohort (n=419, 211)', 'categories': [{'measurements': [{'value': '21.14', 'spread': '14.69', 'groupId': 'OG000'}, {'value': '24.11', 'spread': '14.97', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 57 Cohort (n=421, 210)', 'categories': [{'measurements': [{'value': '16.70', 'spread': '14.06', 'groupId': 'OG000'}, {'value': '21.41', 'spread': '14.15', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 85 Cohort (n=417, 208)', 'categories': [{'measurements': [{'value': '14.84', 'spread': '13.98', 'groupId': 'OG000'}, {'value': '20.58', 'spread': '15.61', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 113 Cohort (n=415, 210)', 'categories': [{'measurements': [{'value': '13.55', 'spread': '13.35', 'groupId': 'OG000'}, {'value': '19.83', 'spread': '15.29', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 141 Cohort (n=420, 211)', 'categories': [{'measurements': [{'value': '12.59', 'spread': '13.39', 'groupId': 'OG000'}, {'value': '19.78', 'spread': '15.74', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 169 Cohort (n=420, 211)', 'categories': [{'measurements': [{'value': '11.69', 'spread': '12.37', 'groupId': 'OG000'}, {'value': '18.70', 'spread': '15.42', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 225 Cohort (n=419, 212)', 'categories': [{'measurements': [{'value': '10.42', 'spread': '12.04', 'groupId': 'OG000'}, {'value': '18.22', 'spread': '15.46', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 281Cohort (n=419, 211)', 'categories': [{'measurements': [{'value': '9.92', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '17.10', 'spread': '16.04', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 365 Cohort (n=424, 212)', 'categories': [{'measurements': [{'value': '9.96', 'spread': '11.87', 'groupId': 'OG000'}, {'value': '18.31', 'spread': '15.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'BL (Day 0) for Day 15 Cohort (n=416, 210)', 'categories': [{'measurements': [{'value': '16.40', 'spread': '8.63', 'groupId': 'OG000'}, {'value': '18.49', 'spread': '9.92', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 29 Cohort (n=419, 211)', 'categories': [{'measurements': [{'value': '14.04', 'spread': '9.26', 'groupId': 'OG000'}, {'value': '16.03', 'spread': '9.23', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 57 Cohort (n=421, 210)', 'categories': [{'measurements': [{'value': '11.02', 'spread': '8.64', 'groupId': 'OG000'}, {'value': '14.77', 'spread': '9.85', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 85 Cohort (n=417, 208)', 'categories': [{'measurements': [{'value': '9.76', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '14.56', 'spread': '10.83', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 113 Cohort (n=415, 210)', 'categories': [{'measurements': [{'value': '8.73', 'spread': '8.64', 'groupId': 'OG000'}, {'value': '13.93', 'spread': '10.69', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 141 Cohort (n=420, 211)', 'categories': [{'measurements': [{'value': '7.84', 'spread': '8.10', 'groupId': 'OG000'}, {'value': '13.28', 'spread': '10.70', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 169 Cohort (n=420, 211)', 'categories': [{'measurements': [{'value': '7.54', 'spread': '7.77', 'groupId': 'OG000'}, {'value': '13.14', 'spread': '11.05', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 225 Cohort (n=419, 212)', 'categories': [{'measurements': [{'value': '6.80', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '12.78', 'spread': '11.06', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 281 Cohort (n=419, 211)', 'categories': [{'measurements': [{'value': '6.50', 'spread': '7.52', 'groupId': 'OG000'}, {'value': '12.46', 'spread': '10.98', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 365 Cohort (n=424, 212)', 'categories': [{'measurements': [{'value': '6.31', 'spread': '7.16', 'groupId': 'OG000'}, {'value': '12.69', 'spread': '10.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 15 (n=413, 210)', 'categories': [{'measurements': [{'value': '52.39', 'spread': '22.85', 'groupId': 'OG000'}, {'value': '60.08', 'spread': '21.90', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n=418, 211)', 'categories': [{'measurements': [{'value': '47.03', 'spread': '23.84', 'groupId': 'OG000'}, {'value': '54.69', 'spread': '23.86', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n=419, 209)', 'categories': [{'measurements': [{'value': '40.34', 'spread': '24.29', 'groupId': 'OG000'}, {'value': '50.11', 'spread': '25.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n=417, 207)', 'categories': [{'measurements': [{'value': '35.97', 'spread': '24.01', 'groupId': 'OG000'}, {'value': '48.36', 'spread': '25.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n=418, 210)', 'categories': [{'measurements': [{'value': '34.31', 'spread': '23.61', 'groupId': 'OG000'}, {'value': '48.60', 'spread': '26.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n=420, 211)', 'categories': [{'measurements': [{'value': '33.93', 'spread': '25.47', 'groupId': 'OG000'}, {'value': '48.26', 'spread': '27.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n=421, 211)', 'categories': [{'measurements': [{'value': '32.69', 'spread': '24.32', 'groupId': 'OG000'}, {'value': '49.21', 'spread': '27.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n=418, 211)', 'categories': [{'measurements': [{'value': '31.39', 'spread': '24.01', 'groupId': 'OG000'}, {'value': '47.20', 'spread': '26.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n=419, 210)', 'categories': [{'measurements': [{'value': '31.06', 'spread': '24.58', 'groupId': 'OG000'}, {'value': '46.18', 'spread': '27.23', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=424, 212)', 'categories': [{'measurements': [{'value': '29.78', 'spread': '24.20', 'groupId': 'OG000'}, {'value': '48.17', 'spread': '27.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 15 (n=405, 206)', 'categories': [{'measurements': [{'value': '1.51', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n=406, 207)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n=412, 205)', 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n=407, 203)', 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n=409, 206)', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n=411, 207)', 'categories': [{'measurements': [{'value': '1.13', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n=413, 207)', 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n=409, 207)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n=408, 207)', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=415, 208)', 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 15 (n=413, 210)', 'categories': [{'measurements': [{'value': '50.90', 'spread': '22.42', 'groupId': 'OG000'}, {'value': '56.66', 'spread': '22.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n=418, 211)', 'categories': [{'measurements': [{'value': '45.26', 'spread': '22.72', 'groupId': 'OG000'}, {'value': '53.11', 'spread': '22.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n=419, 209)', 'categories': [{'measurements': [{'value': '39.78', 'spread': '23.02', 'groupId': 'OG000'}, {'value': '49.34', 'spread': '23.98', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n=417, 207)', 'categories': [{'measurements': [{'value': '35.07', 'spread': '23.37', 'groupId': 'OG000'}, {'value': '46.82', 'spread': '24.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n=418, 210)', 'categories': [{'measurements': [{'value': '33.98', 'spread': '22.59', 'groupId': 'OG000'}, {'value': '47.26', 'spread': '25.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n=420, 211)', 'categories': [{'measurements': [{'value': '33.52', 'spread': '24.06', 'groupId': 'OG000'}, {'value': '47.52', 'spread': '26.57', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n=421, 211)', 'categories': [{'measurements': [{'value': '32.37', 'spread': '23.26', 'groupId': 'OG000'}, {'value': '47.93', 'spread': '26.24', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n=418, 210)', 'categories': [{'measurements': [{'value': '30.63', 'spread': '22.48', 'groupId': 'OG000'}, {'value': '46.06', 'spread': '26.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n=419, 211)', 'categories': [{'measurements': [{'value': '29.98', 'spread': '23.25', 'groupId': 'OG000'}, {'value': '44.45', 'spread': '26.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=424, 212)', 'categories': [{'measurements': [{'value': '28.95', 'spread': '23.60', 'groupId': 'OG000'}, {'value': '45.62', 'spread': '26.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 15 (n=415, 209)', 'categories': [{'measurements': [{'value': '52.79', 'spread': '19.24', 'groupId': 'OG000'}, {'value': '56.68', 'spread': '18.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n=418, 211)', 'categories': [{'measurements': [{'value': '45.24', 'spread': '20.58', 'groupId': 'OG000'}, {'value': '51.83', 'spread': '20.14', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n=421, 210)', 'categories': [{'measurements': [{'value': '35.89', 'spread': '19.84', 'groupId': 'OG000'}, {'value': '45.21', 'spread': '22.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n=416, 208)', 'categories': [{'measurements': [{'value': '31.07', 'spread': '20.12', 'groupId': 'OG000'}, {'value': '42.59', 'spread': '23.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n=412, 209)', 'categories': [{'measurements': [{'value': '29.01', 'spread': '20.40', 'groupId': 'OG000'}, {'value': '42.20', 'spread': '24.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n=420, 211)', 'categories': [{'measurements': [{'value': '26.71', 'spread': '20.38', 'groupId': 'OG000'}, {'value': '41.22', 'spread': '25.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n=421, 211)', 'categories': [{'measurements': [{'value': '25.44', 'spread': '19.65', 'groupId': 'OG000'}, {'value': '41.75', 'spread': '25.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n=418, 212)', 'categories': [{'measurements': [{'value': '24.34', 'spread': '19.27', 'groupId': 'OG000'}, {'value': '40.68', 'spread': '26.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n=419, 210)', 'categories': [{'measurements': [{'value': '23.33', 'spread': '19.09', 'groupId': 'OG000'}, {'value': '38.76', 'spread': '26.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=424, 212)', 'categories': [{'measurements': [{'value': '21.58', 'spread': '19.53', 'groupId': 'OG000'}, {'value': '41.04', 'spread': '25.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 15 (n=401, 199)', 'categories': [{'measurements': [{'value': '3.27', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '2.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n=410, 208)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n=416, 209)', 'categories': [{'measurements': [{'value': '1.70', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '2.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n=412, 203)', 'categories': [{'measurements': [{'value': '1.53', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n=417, 209)', 'categories': [{'measurements': [{'value': '1.49', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '2.55', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n=414, 209)', 'categories': [{'measurements': [{'value': '1.27', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '2.48', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n=420, 211)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n=414, 212)', 'categories': [{'measurements': [{'value': '1.30', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n=412, 210)', 'categories': [{'measurements': [{'value': '1.36', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '3.09', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=424, 212)', 'categories': [{'measurements': [{'value': '1.27', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '2.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.', 'unitOfMeasure': 'IU / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discontinuing in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 1 to 169 Discontinuations (DC) - All Causes', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 to 169 DC Due to Lack of Efficacy', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Day 170 to Day 365 DC - All Causes', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Day 170 to Day 365 DC Due to Lack of Efficacy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 169, Day 170 to Day 365', 'description': 'Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants in the DB period.'}, {'type': 'SECONDARY', 'title': 'Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'paramType': 'NUMBER', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not completed.'}, {'type': 'PRIMARY', 'title': 'Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX OL', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuations Due to SAEs', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': '518', 'groupId': 'OG000'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000'}]}]}, {'title': 'Discontinued Due to AEs', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period.'}, {'type': 'PRIMARY', 'title': 'Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX OL', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Low Hemoglobin (LLN 11.5 g/dL)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Low Hematocrit (LLN 34%)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Low Erythrocytes (LLN 38 x 10^6 c/µL)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Low Platelet Count (LLN 140 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'High Platelet Count (ULN 415 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Low Leukocytes (LLN 4 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'High Leukocytes (ULN 10.5 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Low Absolute Neutrophils (LLN 1.8 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Low Absolute Lymphocytes (LLN 0.7 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}, {'title': 'High Absolute Lymphocytes (ULN 4.5 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'High Absolute Monocytes (ULN 1.0 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'High Absolute Basophils (ULN 0.2 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'High Absolute Eosinophils (ULN 0.4 x 10^3 c/µL)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'Marked abnormality criteria are: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period.'}, {'type': 'PRIMARY', 'title': 'Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX OL', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'High ALP (ULN 150 U/L)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'High AST (ULN 40 U/L)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'High ALT (ULN 55 U/L)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'High GGT (ULN 65 U/L)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'High Bilirubin (ULN 1.2 mg/dL)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'High BUN (ULN 26 mg/dL)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'High Creatinine (ULN 1.5 mg/dL)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'Marked abnormality criteria are: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period.'}, {'type': 'PRIMARY', 'title': 'Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX OL', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Low Sodium (LLN 135 mmol/L)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'High Sodium (ULN 148 mmol/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Low Potassium (LLN 3.5 mmol/L)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'High Potassium (ULN 5.5 mmol/L)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Low Chloride (LLN 96 mmol/L)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'High Chloride (ULN 109 mmol/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Low Calcium (LLN 8.5 mg/dL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'High Calcium (ULN 10.6 mg/dL)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Low Phosphorous (LLN 2.5 mg/dL)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'High Phosphorous (ULN 5.6 mg/dL)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'Sodium \\< 0.9 \\* LLN or \\> 1.05 \\* ULN or if BL \\< LLN then use \\< 0.95 \\* BL or \\> ULN or if BL \\> ULN then use \\>1.05 \\*BL or \\< LLN; Potassium: \\< 0.9 \\* LLN or \\> 1.1 \\* ULN or if BL \\< LLN then use \\< 0.9 \\* BL or \\> ULN or if BL \\> ULN then use 1.1 \\* BL or \\< LLN; Chloride: \\< 0.9 \\* LLN or \\> 1.1 \\* ULN or if BL \\< LLN then use \\<0.9 \\* BL or \\>ULN or if BL \\> ULN then use \\> 1.1 \\* BL or \\< LLN; Calcium \\<0.8 \\* LLN or \\> 1.2 \\* ULN or if BL \\< LLN then use \\<0.67 \\* BL or \\> ULN or if BL \\> ULN then use \\> 1.3 \\* BL or \\< LLN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period.'}, {'type': 'PRIMARY', 'title': 'Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX OL', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Low Serum Glucose (LLN 64 mg/dL)', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}]}]}, {'title': 'High Serum Glucose (ULN 140 mg/dL)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Low Serum Fasting Glucose (LLN 65 mg/dL)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'High Serum Fasting Glucose (ULN 109 mg/dL)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Low Total Protein (LLN 6 g/dL)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'High Total Protein (ULN 8.5 g/dL)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Low Albumin (LLN 3.5 g/dL)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'High Uric Acid (ULN 8.7 mg/dL)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'High Urine Protein (ULN Trace)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'High Urine Glucose (ULN Trace)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'High Urine Ketones (ULN Positive)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'High Urine Blood (ULN >=0)', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}]}]}, {'title': 'High Urine Leukocyte Esterase (ULN >=0)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'High Urine White Blood Count (ULN 12 hpf)', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}]}]}, {'title': 'High Urine Red Blood Count (ULN 8 hpf)', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'Glucose: \\< 65 mg/dL or \\> 220 mg/dL; Fasting Glucose: \\<0.8 \\* LLN or \\> 1.5 \\* ULN or if BL \\< LLN then use \\< 0.8 \\* BL or \\> ULN or if BL \\> ULN then use 1.1 \\* BL or \\< LLN; Total protein: \\< 0.9 \\* LLN or 1.1 \\* ULN or if BL \\< LLN then use 0.9 \\* BL or \\> ULN or if BL \\> ULN then use 1.1 \\* BL or \\< LLN; Albumin: \\< 0.9 \\* LLN or if BL \\< LLN then use 0.75 \\* BL; Uric acid: \\> 1.5 \\* ULN or if BL \\> ULN then use \\> 2.0 \\* BL. All urinalysis abnormalities were defined as: if missing BL then use \\>= 2 or if value \\>=4, or if BL = 0 or 0.5 then use \\>= 2, or if BL = 1.0 then use \\>= 3, or if BL = 2.0 then use \\>=4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period.'}, {'type': 'SECONDARY', 'title': 'Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365', 'description': 'All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants.'}, {'type': 'SECONDARY', 'title': 'Participants Experiencing AEs of Special Interest in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Infections/Infestations', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Neoplasms', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Autoimmune Disorders', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Acute Infusional AEs', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365', 'description': 'AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the DB period.'}, {'type': 'SECONDARY', 'title': 'Mean BL Individual Components of the HAQ DI at Day 169 and Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'HAQ DI Day 169 (n=373, 159)', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'HAQ DI Day 365 (n=369, 160)', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming Day 169 (n=374, 159)', 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming Day 365 (n=372, 160)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Arising Day 169 (n=373, 159)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Arising Day 365 (n=372, 160)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Eating Day 169 (n=374, 159)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Eating Day 365 (n=372, 160)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Walking Day 169 (n=373, 158)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Walking Day 365 (n=372, 158)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene Day 169 (n=373, 159)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene Day 365 (n=370, 160)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Reaching Day 169 (n=373, 159)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Reaching Day 365 (n=370, 160)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Gripping Day 169 (n=374, 159)', 'categories': [{'measurements': [{'value': '1.80', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Gripping Day 365 (n=371, 160)', 'categories': [{'measurements': [{'value': '1.80', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Activities Day 169 (n=373, 159)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Activities Day 365 (n=369, 160)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'HAQ DI', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Arising', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Eating', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Walking', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Reaching', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Gripping', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Activities', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 169', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'HAQ DI', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Arising', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Eating', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Walking', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Reaching', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Gripping', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Activities', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Immunogenicity to Abatacept in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the DB period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365', 'description': 'Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with abatacept in the DB period with at least one immunogenicity sample collected in the DB period.'}, {'type': 'SECONDARY', 'title': 'Number of New Tender Joints and Number of New Swollen Joints in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 169, Day 365', 'description': 'Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.', 'unitOfMeasure': 'Joints', 'reportingStatus': 'POSTED', 'populationDescription': 'These data were not summarized as it was determined that no meaningful information would be obtained.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': '100% Reduction in New Tender Joints Day 169', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '100% Reduction in New Swollen Joints Day 169', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '100% Reduction in New Tender Joints Day 365', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '100% Reduction in New Swollen Joints Day 365', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 169, Day 365', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Low Hemoglobin (LLN 11.5 g/dL)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Low Hematocrit (LLN 34%)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Low Platelet Count (LLN 140 x 10^3 c/uL)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'High Platelet Count (ULN 415 x 10^3 c/uL)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Low Leukocytes (LLN 4.0 x 10^3 c/uL)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'High Leukocytes (ULN 10.5 x 10^3 c/uL)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Low Absolute Neutrophils (LLN 1.8 x 10^3 c/uL)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365', 'description': 'Marked abnormality criteria were: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the DB period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'Placebo + MTX DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'High AST (ULN 40 U/L)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'High ALT (ULN 55 U/L)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'High Creatinine (ULN 1.5 mg/ dL)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365', 'description': 'Marked abnormality criteria were: Aspartate Aminotransferase (AST) \\>3 \\* ULN or if BL \\> ULN then use \\>4 \\*BL; Alanine Aminotransferase (ALT) \\>3 \\* ULN or if BL \\> ULN then use \\> 4 \\* BL; Creatinine \\> 1.5 \\* BL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the DB period.'}, {'type': 'SECONDARY', 'title': 'Mean BL ESR and CRP Levels in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'ESR Day 365 (n=343, 141)', 'categories': [{'measurements': [{'value': '43.56', 'spread': '22.98', 'groupId': 'OG000'}, {'value': '43.61', 'spread': '25.25', 'groupId': 'OG001'}]}]}, {'title': 'CRP Day 365 (n=373, 160)', 'categories': [{'measurements': [{'value': '32.48', 'spread': '31.41', 'groupId': 'OG000'}, {'value': '24.72', 'spread': '20.74', 'groupId': 'OG001'}]}]}, {'title': 'ESR Day 729 (n=307, 132)', 'categories': [{'measurements': [{'value': '43.74', 'spread': '23.44', 'groupId': 'OG000'}, {'value': '41.37', 'spread': '24.15', 'groupId': 'OG001'}]}]}, {'title': 'CRP Day 729 (n=348, 153)', 'categories': [{'measurements': [{'value': '32.12', 'spread': '30.99', 'groupId': 'OG000'}, {'value': '23.46', 'spread': '19.65', 'groupId': 'OG001'}]}]}, {'title': 'ESR Day 1,093 (n=283, 123)', 'categories': [{'measurements': [{'value': '43.57', 'spread': '23.34', 'groupId': 'OG000'}, {'value': '42.41', 'spread': '25.25', 'groupId': 'OG001'}]}]}, {'title': 'CRP Day 1,093 (n=306, 131)', 'categories': [{'measurements': [{'value': '31.96', 'spread': '30.35', 'groupId': 'OG000'}, {'value': '24.09', 'spread': '19.85', 'groupId': 'OG001'}]}]}, {'title': 'ESR Day 1,457 (n=270, 111)', 'categories': [{'measurements': [{'value': '43.49', 'spread': '23.71', 'groupId': 'OG000'}, {'value': '42.87', 'spread': '24.27', 'groupId': 'OG001'}]}]}, {'title': 'CRP Day 1,457 (n=295, 132)', 'categories': [{'measurements': [{'value': '32.13', 'spread': '30.14', 'groupId': 'OG000'}, {'value': '23.20', 'spread': '19.22', 'groupId': 'OG001'}]}]}, {'title': 'ESR Day 1,821 (n=257, 109)', 'categories': [{'measurements': [{'value': '43.03', 'spread': '22.86', 'groupId': 'OG000'}, {'value': '41.83', 'spread': '24.01', 'groupId': 'OG001'}]}]}, {'title': 'CRP Day 1,821 (n=275, 124)', 'categories': [{'measurements': [{'value': '31.41', 'spread': '29.30', 'groupId': 'OG000'}, {'value': '22.14', 'spread': '18.34', 'groupId': 'OG001'}]}]}, {'title': 'ESR Day 1,989 (n=114, 49)', 'categories': [{'measurements': [{'value': '42.61', 'spread': '24.00', 'groupId': 'OG000'}, {'value': '38.78', 'spread': '19.64', 'groupId': 'OG001'}]}]}, {'title': 'CRP Day 1,989 (n=128, 61)', 'categories': [{'measurements': [{'value': '33.22', 'spread': '34.65', 'groupId': 'OG000'}, {'value': '20.39', 'spread': '14.43', 'groupId': 'OG001'}]}]}, {'title': 'ESR Day 2,185 (n=76, 29)', 'categories': [{'measurements': [{'value': '45.04', 'spread': '23.46', 'groupId': 'OG000'}, {'value': '39.17', 'spread': '21.30', 'groupId': 'OG001'}]}]}, {'title': 'CRP Day 2,185 (n=83, 38)', 'categories': [{'measurements': [{'value': '34.73', 'spread': '36.05', 'groupId': 'OG000'}, {'value': '22.08', 'spread': '15.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185', 'description': 'Mean baseline values are reported for each cohort at each time point.', 'unitOfMeasure': 'IU / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in ESR in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=343, 141)', 'categories': [{'measurements': [{'value': '-17.9', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-6.85', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=307, 132)', 'categories': [{'measurements': [{'value': '-19.3', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-16.3', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=283, 123)', 'categories': [{'measurements': [{'value': '-17.2', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=270, 111)', 'categories': [{'measurements': [{'value': '-17.7', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-16.3', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=257, 109)', 'categories': [{'measurements': [{'value': '-17.7', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '2.26', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=114, 49)', 'categories': [{'measurements': [{'value': '-17.3', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=76, 29)', 'categories': [{'measurements': [{'value': '-22.1', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '-21.0', 'spread': '4.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185', 'description': 'Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.', 'unitOfMeasure': 'IU / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Participant RF Seroconversion in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Positive Seroconversion Day 365 (n=347, 146)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Negative Seroconversion Day 365 (n=347, 146)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Positive Seroconversion Day 729 (n=330, 143)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Negative Seroconversion Day 729 (n=330, 143)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Positive Seroconversion Day 1,093 (n=280, 119)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Negative Seroconversion Day 1,093 (n=280, 119)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Positive Seroconversion Day 1,457 (n=275, 118)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Negative Seroconversion Day 1,457 (n=275, 118)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Positive Seroconversion Day 1,821 (n=255, 115)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Negative Seroconversion Day 1,821 (n=255, 115)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Positive Seroconversion Day 2,185 (n=75, 31)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Negative Seroconversion Day 2,185 (n=75, 31)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185', 'description': 'This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was \\> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Number of ACR 20 Responders in the DB and OL Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 15 (n = 370, n = 158)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n = 368, n=158)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n = 371, n = 159)', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n = 367, n = 158)', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n = 367, n = 159)', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n = 368, n = 159)', 'categories': [{'measurements': [{'value': '275', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n = 371, n = 159)', 'categories': [{'measurements': [{'value': '272', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n = 369, n = 158)', 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n = 367, n = 159)', 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n = 373, n = 159)', 'categories': [{'measurements': [{'value': '307', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n = 363, n = 155)', 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n = 353, n = 155)', 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n = 347, n = 155)', 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n = 337, n = 147)', 'categories': [{'measurements': [{'value': '296', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n = 322, n = 143)', 'categories': [{'measurements': [{'value': '273', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n = 311, n = 136)', 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n = 298, n = 133)', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n = 303, n = 134)', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n = 265, n = 117)', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n = 289, n = 131)', 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n = 133, n = 53)', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n = 288, n = 128)', 'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n = 273, n= 126)', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n = 268, n = 123)', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n = 119, n = 54)', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n = 85, n = 37)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821', 'description': 'ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Number of ACR 50 Responders in the DB and OL Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 15 (n = 371, n = 160)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n = 368, n=158)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n = 373, n = 159)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n = 367, n = 158)', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n = 368, n = 159)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n = 371, n = 159)', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n = 373, n = 159)', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n = 370, n = 159)', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n = 369, n = 159)', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n = 372, n = 160)', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n = 366, n = 155)', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n = 348, n = 156)', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n = 346, n = 155)', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n = 338, n = 147)', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n = 321, n = 145)', 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n = 314, n = 136)', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n = 302, n = 133)', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n = 306, n = 135)', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n = 266, n = 118)', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n = 289, n = 130)', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n = 141, n = 56)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n = 288, n = 127)', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n = 274, n= 126)', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n = 270, n = 123)', 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n = 121, n = 55)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n = 83, n = 37)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821', 'description': 'ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Number of ACR 70 Responders in the DB and OL Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 15 (n = 371, n = 160)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n = 369, n=159)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n = 374, n = 159)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n = 370, n = 158)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n = 371, n = 159)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n = 371, n = 159)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n = 374, n = 159)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n = 369, n = 160)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n = 372, n = 160)', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n = 374, n = 160)', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n = 367, n = 157)', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n = 350, n = 156)', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n = 347, n = 154)', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n = 340, n = 147)', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n = 325, n = 146)', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n = 314, n = 138)', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n = 306, n = 134)', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n = 309, n = 137)', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n = 265, n = 122)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n = 289, n = 132)', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n = 139, n = 57)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n = 288, n = 128)', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n = 278, n= 125)', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n = 270, n = 125)', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n = 119, n = 54)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n = 83, n = 37)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821', 'description': 'ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Remission Day 15 (n = 355, n = 152)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 15 (n=355, 152)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 29 (n = 362, n =157)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 29 (n=362, 157)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 57 (n = 367, n = 156)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 57 (n=367, 156)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 85 (n = 366, n = 152)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 85 (n=366, 152)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 113 (n = 367, n = 159)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 113 (n=367, 159)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 141 (n = 366, n = 158)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 141 (n=366, 158)', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 169 (n = 371, n = 159)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 169 (n=371, 159)', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 225 (n = 366, n = 158)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 225 (n=366, 158)', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 281 (n = 364, n = 159)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 281 (n=364, 159)', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 365 (n = 370, n = 159)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 365 (n=370, 159)', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 449 (n = 357, n = 150)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 449 (n=357, 150)', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 533 (n = 343, n = 150)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 553 (n=343, 150)', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 617 (n = 334, n = 153)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 617 (n=334, 153)', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 729 (n = 337, n = 148)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 729 (n=337, 148)', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 813 (n = 317, n = 143)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 813 (n=317, 143)', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 897 (n = 303, n = 135)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 897 (n=303, 135)', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 981 (n = 297, n = 133)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 981 (n=297, 133)', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 1,093 (n = 300, n = 129)', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 1,093 (n=300, 129)', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 1,177 (n = 158, n = 71)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 1,177 (n=158, 71)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 1,261 (n = 267, n = 119)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 1,261 (n=267, 119)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 1,457 (n = 284, n = 129)', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 1,457 (n=284, 129)', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 1,625 (n = 272, n= 124)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 1,625 (n=272, 124)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 1,821 (n = 270, n = 124)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 1,821 (n=270, 124)', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 1,989 (n=118, 54)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 1,989 (n=118, 54)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Remission Day 2,185 (n=82, 37)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Low Disease Activity Day 2,185 (n=82, 37)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\\> 5.1); low (≤ 3.2); remission (\\< 2.6).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 15 Cohort (n=352, 150)', 'categories': [{'measurements': [{'value': '6.36', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.32', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 29 Cohort (n=357, 154)', 'categories': [{'measurements': [{'value': '6.36', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 57 Cohort (n=362, 153)', 'categories': [{'measurements': [{'value': '6.36', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 85 Cohort (n=362, 149)', 'categories': [{'measurements': [{'value': '6.35', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 113 Cohort (n=362, 149)', 'categories': [{'measurements': [{'value': '6.35', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.34', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 141 Cohort (n=361, 155)', 'categories': [{'measurements': [{'value': '6.34', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 169 Cohort (n=366, 156)', 'categories': [{'measurements': [{'value': '6.35', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '6.34', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 225 Cohort (n=361, 155)', 'categories': [{'measurements': [{'value': '6.35', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 281 Cohort (n=359, 156)', 'categories': [{'measurements': [{'value': '6.35', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 365 Cohort (n=365, 156)', 'categories': [{'measurements': [{'value': '6.36', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=352, 147)', 'categories': [{'measurements': [{'value': '6.37', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.34', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=338, 147)', 'categories': [{'measurements': [{'value': '6.38', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=329, 150)', 'categories': [{'measurements': [{'value': '6.37', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=333, 145)', 'categories': [{'measurements': [{'value': '6.37', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.36', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=313, 140)', 'categories': [{'measurements': [{'value': '6.39', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=301, 133)', 'categories': [{'measurements': [{'value': '6.38', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=294, 131)', 'categories': [{'measurements': [{'value': '6.39', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=296, 127)', 'categories': [{'measurements': [{'value': '6.37', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=156, 70)', 'categories': [{'measurements': [{'value': '6.43', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '6.38', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=267, 117)', 'categories': [{'measurements': [{'value': '6.39', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '6.34', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=281, 126)', 'categories': [{'measurements': [{'value': '6.40', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=269, 121)', 'categories': [{'measurements': [{'value': '6.39', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.40', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=267, 122)', 'categories': [{'measurements': [{'value': '6.39', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 53)', 'categories': [{'measurements': [{'value': '6.53', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '6.49', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=82, 36)', 'categories': [{'measurements': [{'value': '6.41', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '6.38', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'mg / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 15 (n=352, 150)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n=357, 154)', 'categories': [{'measurements': [{'value': '-1.27', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n=362, 153)', 'categories': [{'measurements': [{'value': '-1.80', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n=362, 149)', 'categories': [{'measurements': [{'value': '-2.12', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n=362, 149)', 'categories': [{'measurements': [{'value': '-2.30', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n=361, 155)', 'categories': [{'measurements': [{'value': '-2.46', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n=366, 156)', 'categories': [{'measurements': [{'value': '-2.48', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.57', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n=361, 155)', 'categories': [{'measurements': [{'value': '-2.72', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n=359, 156)', 'categories': [{'measurements': [{'value': '-2.81', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=365, 156)', 'categories': [{'measurements': [{'value': '-2.83', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=352, 147)', 'categories': [{'measurements': [{'value': '-2.91', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-2.68', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=338, 147)', 'categories': [{'measurements': [{'value': '-3.01', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-2.79', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=329, 150)', 'categories': [{'measurements': [{'value': '-3.00', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-2.92', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=333, 145)', 'categories': [{'measurements': [{'value': '-3.10', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-3.02', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=313, 140)', 'categories': [{'measurements': [{'value': '-3.09', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-3.05', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=301, 133)', 'categories': [{'measurements': [{'value': '-3.06', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-3.11', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=294, 131)', 'categories': [{'measurements': [{'value': '-3.21', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.14', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=296, 127)', 'categories': [{'measurements': [{'value': '-3.21', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.15', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=156, 70)', 'categories': [{'measurements': [{'value': '-3.27', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-3.21', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=267, 117)', 'categories': [{'measurements': [{'value': '-3.22', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.15', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=281, 126)', 'categories': [{'measurements': [{'value': '-3.29', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=269, 121)', 'categories': [{'measurements': [{'value': '-3.23', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.34', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=267, 122)', 'categories': [{'measurements': [{'value': '-3.14', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.26', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 53)', 'categories': [{'measurements': [{'value': '-3.39', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-3.31', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=82, 36)', 'categories': [{'measurements': [{'value': '-3.04', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-3.30', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Change from baseline in participant were calculated at all study visits in the DB and OL periods.', 'unitOfMeasure': 'mg / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL DAS-28 ESR Over Time in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=352, 148)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=345, 145)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '6.89', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=332, 146)', 'categories': [{'measurements': [{'value': '6.83', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=325, 148)', 'categories': [{'measurements': [{'value': '6.85', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=315, 139)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '6.87', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=303, 134)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '6.90', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=296, 128)', 'categories': [{'measurements': [{'value': '6.83', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '6.85', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=282, 119)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=287, 130)', 'categories': [{'measurements': [{'value': '6.83', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '6.87', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=241, 110)', 'categories': [{'measurements': [{'value': '6.86', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '6.89', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=271, 121)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=269, 117)', 'categories': [{'measurements': [{'value': '6.87', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=260, 118)', 'categories': [{'measurements': [{'value': '6.86', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=259, 114)', 'categories': [{'measurements': [{'value': '6.85', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '6.87', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=108, 47)', 'categories': [{'measurements': [{'value': '6.95', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '7.04', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=76, 31)', 'categories': [{'measurements': [{'value': '6.90', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'IU / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in DAS-28 ESR Over Time in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=352, 148)', 'categories': [{'measurements': [{'value': '-2.96', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=345, 145)', 'categories': [{'measurements': [{'value': '-3.04', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-2.87', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=332, 146)', 'categories': [{'measurements': [{'value': '-3.14', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=325, 148)', 'categories': [{'measurements': [{'value': '-3.17', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.02', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=315, 139)', 'categories': [{'measurements': [{'value': '-3.27', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-3.20', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=303, 134)', 'categories': [{'measurements': [{'value': '-3.13', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.18', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=296, 128)', 'categories': [{'measurements': [{'value': '-3.11', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.10', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=282, 119)', 'categories': [{'measurements': [{'value': '-3.26', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-3.19', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=287, 130)', 'categories': [{'measurements': [{'value': '-3.23', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.22', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=241, 110)', 'categories': [{'measurements': [{'value': '-3.33', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-3.29', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=271, 121)', 'categories': [{'measurements': [{'value': '-3.25', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.18', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=269, 117)', 'categories': [{'measurements': [{'value': '-3.32', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=260, 118)', 'categories': [{'measurements': [{'value': '-3.30', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-3.27', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=259, 114)', 'categories': [{'measurements': [{'value': '-3.22', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-3.34', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=108, 47)', 'categories': [{'measurements': [{'value': '-3.41', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-3.42', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=76, 31)', 'categories': [{'measurements': [{'value': '-3.25', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-3.66', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.', 'unitOfMeasure': 'IU / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean BL Immunoglobulins Over Time in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'Placebo + MTX DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Immunoglobulin A (IgA) Day 365', 'categories': [{'measurements': [{'value': '327.0', 'spread': '135.2', 'groupId': 'OG000'}, {'value': '319.2', 'spread': '145.1', 'groupId': 'OG001'}]}]}, {'title': 'Immunoglobulin G (IgG) Day 365', 'categories': [{'measurements': [{'value': '1278', 'spread': '412.4', 'groupId': 'OG000'}, {'value': '1317', 'spread': '425.4', 'groupId': 'OG001'}]}]}, {'title': 'Immunoglobulin M (IgM) Day 365', 'categories': [{'measurements': [{'value': '145.1', 'spread': '86.72', 'groupId': 'OG000'}, {'value': '154.3', 'spread': '85.53', 'groupId': 'OG001'}]}]}, {'title': 'IgA Day 729', 'categories': [{'measurements': [{'value': '328.0', 'spread': '133.8', 'groupId': 'OG000'}, {'value': '317.0', 'spread': '145.0', 'groupId': 'OG001'}]}]}, {'title': 'IgG Day 729', 'categories': [{'measurements': [{'value': '1280', 'spread': '410.4', 'groupId': 'OG000'}, {'value': '1315', 'spread': '425.3', 'groupId': 'OG001'}]}]}, {'title': 'IgM Day 729', 'categories': [{'measurements': [{'value': '146.2', 'spread': '87.34', 'groupId': 'OG000'}, {'value': '153.1', 'spread': '85.80', 'groupId': 'OG001'}]}]}, {'title': 'IgA Day 1,093', 'categories': [{'measurements': [{'value': '321.8', 'spread': '133.4', 'groupId': 'OG000'}, {'value': '318.5', 'spread': '145.7', 'groupId': 'OG001'}]}]}, {'title': 'IgG Day 1,093', 'categories': [{'measurements': [{'value': '1273', 'spread': '392.3', 'groupId': 'OG000'}, {'value': '1319', 'spread': '436.8', 'groupId': 'OG001'}]}]}, {'title': 'IgM Day 1,093', 'categories': [{'measurements': [{'value': '148.6', 'spread': '91.01', 'groupId': 'OG000'}, {'value': '153.5', 'spread': '88.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.', 'unitOfMeasure': 'mg / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).'}, {'type': 'PRIMARY', 'title': 'Mean Change From BL in Immunoglobulins in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'Placebo + MTX DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'IgA Day 365', 'categories': [{'measurements': [{'value': '-47.8', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '-8.30', 'spread': '6.41', 'groupId': 'OG001'}]}]}, {'title': 'IgG Day 365', 'categories': [{'measurements': [{'value': '-212', 'spread': '12.77', 'groupId': 'OG000'}, {'value': '-52.7', 'spread': '18.96', 'groupId': 'OG001'}]}]}, {'title': 'IgM Day 365', 'categories': [{'measurements': [{'value': '-5.05', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '6.95', 'spread': '9.73', 'groupId': 'OG001'}]}]}, {'title': 'IgA Day 729', 'categories': [{'measurements': [{'value': '-38.6', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '-26.6', 'spread': '9.95', 'groupId': 'OG001'}]}]}, {'title': 'IgG Day 729', 'categories': [{'measurements': [{'value': '-215', 'spread': '14.10', 'groupId': 'OG000'}, {'value': '-206', 'spread': '21.86', 'groupId': 'OG001'}]}]}, {'title': 'IgM Day 729', 'categories': [{'measurements': [{'value': '8.04', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '6.49', 'spread': '5.76', 'groupId': 'OG001'}]}]}, {'title': 'IgA Day 1,093', 'categories': [{'measurements': [{'value': '-46.8', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '-37.9', 'spread': '9.66', 'groupId': 'OG001'}]}]}, {'title': 'IgG Day 1,093', 'categories': [{'measurements': [{'value': '-236', 'spread': '15.94', 'groupId': 'OG000'}, {'value': '-245', 'spread': '25.44', 'groupId': 'OG001'}]}]}, {'title': 'IgM Day 1,093', 'categories': [{'measurements': [{'value': '4.38', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '6.01', 'spread': '5.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093', 'unitOfMeasure': 'mg / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).'}, {'type': 'PRIMARY', 'title': 'Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX Cumulative DB + OL Periods', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the DB and OL periods under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 1,821', 'description': 'Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with serum samples available for evaluation of titers to abatacept.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 15 (n = 367, n = 160)', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (n = 365, n = 159)', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n = 372, n = 157)', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n = 366, n = 156)', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n = 369, n = 159)', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n = 370, n = 159)', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n = 373, n = 159)', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n = 368, n = 159)', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n = 368, n = 160)', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n = 369, n = 160)', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n = 366, n = 157)', 'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n = 354, n = 157)', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n = 348, n = 154)', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n = 337, n = 148)', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n = 325, n= 146)', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n = 318, n = 140)', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n = 312, n = 137)', 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n = 308, n = 137)', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n = 274, n = 124)', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n = 292, n = 134)', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n = 152, n = 62)', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n = 289, n = 129)', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n =280, n = 126)', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n = 271, n = 125)', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n = 119, n = 55)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n = 85, n = 38)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort Erosion (n=291, 131)', 'categories': [{'measurements': [{'value': '17.65', 'spread': '15.81', 'groupId': 'OG000'}, {'value': '18.69', 'spread': '17.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 Erosion Change From BL (n=291, 131)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 365 Cohort JSN (n=291, 131)', 'categories': [{'measurements': [{'value': '10.83', 'spread': '14.02', 'groupId': 'OG000'}, {'value': '12.02', 'spread': '14.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 JSN Change From BL(n=291, 131)', 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 365 Cohort TS (n=291, 131)', 'categories': [{'measurements': [{'value': '28.48', 'spread': '29.01', 'groupId': 'OG000'}, {'value': '30.71', 'spread': '30.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 TS Change From BL (n=291, 131)', 'categories': [{'measurements': [{'value': '0.80', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '3.35', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort Erosion (n=290, 130)', 'categories': [{'measurements': [{'value': '17.40', 'spread': '15.41', 'groupId': 'OG000'}, {'value': '18.88', 'spread': '17.18', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 Erosion Change From BL (n=291, 131)', 'categories': [{'measurements': [{'value': '0.59', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '2.74', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort JSN (n=291, 131)', 'categories': [{'measurements': [{'value': '10.65', 'spread': '13.80', 'groupId': 'OG000'}, {'value': '12.21', 'spread': '14.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 JSN Change From BL(n=291, 131)', 'categories': [{'measurements': [{'value': '0.55', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '2.79', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort TS (n=291, 131)', 'categories': [{'measurements': [{'value': '28.05', 'spread': '28.41', 'groupId': 'OG000'}, {'value': '31.09', 'spread': '30.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 TS Change From BL(n=291, 131)', 'categories': [{'measurements': [{'value': '1.14', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '5.22', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1093 Cohort Erosion (n=293,130)', 'categories': [{'measurements': [{'value': '17.66', 'spread': '15.78', 'groupId': 'OG000'}, {'value': '18.69', 'spread': '17.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 1093 Erosion Change From BL (n=293, 130)', 'categories': [{'measurements': [{'value': '0.92', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1093 Cohort JSN (n=293, 130)', 'categories': [{'measurements': [{'value': '10.84', 'spread': '13.97', 'groupId': 'OG000'}, {'value': '12.02', 'spread': '14.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 1093 JSN Change From BL (n=293, 130)', 'categories': [{'measurements': [{'value': '0.73', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1093 Cohort TS (n=293, 130)', 'categories': [{'measurements': [{'value': '28.50', 'spread': '28.94', 'groupId': 'OG000'}, {'value': '30.71', 'spread': '30.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 1093 Total Score Change From BL (n=293, 130)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '6.60', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1457 Cohort Erosion (n=290,128)', 'categories': [{'measurements': [{'value': '17.46', 'spread': '15.46', 'groupId': 'OG000'}, {'value': '18.94', 'spread': '17.30', 'groupId': 'OG001'}]}]}, {'title': 'Day 1457 Erosion Change From BL (n=290, 128)', 'categories': [{'measurements': [{'value': '1.16', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '4.30', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1457 Cohort JSN (n=290, 128)', 'categories': [{'measurements': [{'value': '10.66', 'spread': '13.71', 'groupId': 'OG000'}, {'value': '12.12', 'spread': '14.64', 'groupId': 'OG001'}]}]}, {'title': 'Day 1457 JSN Change From BL (n=290, 128)', 'categories': [{'measurements': [{'value': '0.85', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '3.73', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1457 Cohort TS (n=290, 128)', 'categories': [{'measurements': [{'value': '28.12', 'spread': '28.35', 'groupId': 'OG000'}, {'value': '31.06', 'spread': '31.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 1457 TS Change From BL (n=290, 128)', 'categories': [{'measurements': [{'value': '2.01', 'spread': '5.00', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '7.55', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1821 Cohort Erosion (n=233,114)', 'categories': [{'measurements': [{'value': '17.62', 'spread': '15.62', 'groupId': 'OG000'}, {'value': '18.93', 'spread': '17.37', 'groupId': 'OG001'}]}]}, {'title': 'Day 1821 Erosion Change From BL (n=233, 114)', 'categories': [{'measurements': [{'value': '1.12', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '4.88', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1821 Cohort JSN (n=233, 114)', 'categories': [{'measurements': [{'value': '10.77', 'spread': '13.73', 'groupId': 'OG000'}, {'value': '12.01', 'spread': '14.47', 'groupId': 'OG001'}]}]}, {'title': 'Day 1821 JSN Change From BL (n=233, 114)', 'categories': [{'measurements': [{'value': '0.90', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '4.11', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1821 Cohort TS (n=233, 114)', 'categories': [{'measurements': [{'value': '28.39', 'spread': '28.50', 'groupId': 'OG000'}, {'value': '30.94', 'spread': '30.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 1821 TS Change From BL (n=233, 114)', 'categories': [{'measurements': [{'value': '2.02', 'spread': '4.93', 'groupId': 'OG000'}, {'value': '3.78', 'spread': '8.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821', 'description': 'Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=370, 157)', 'categories': [{'measurements': [{'value': '30.69', 'spread': '6.84', 'groupId': 'OG000'}, {'value': '30.94', 'spread': '7.32', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=362, 156)', 'categories': [{'measurements': [{'value': '30.55', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '30.95', 'spread': '7.34', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 155)', 'categories': [{'measurements': [{'value': '30.64', 'spread': '6.79', 'groupId': 'OG000'}, {'value': '30.86', 'spread': '7.34', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 153)', 'categories': [{'measurements': [{'value': '30.70', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '30.88', 'spread': '7.37', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=338, 146)', 'categories': [{'measurements': [{'value': '30.75', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '30.88', 'spread': '7.25', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=323, 145)', 'categories': [{'measurements': [{'value': '30.58', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '31.00', 'spread': '7.29', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 139)', 'categories': [{'measurements': [{'value': '30.52', 'spread': '6.69', 'groupId': 'OG000'}, {'value': '30.87', 'spread': '7.41', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 136)', 'categories': [{'measurements': [{'value': '30.49', 'spread': '6.64', 'groupId': 'OG000'}, {'value': '30.98', 'spread': '7.46', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=308, 137)', 'categories': [{'measurements': [{'value': '30.51', 'spread': '6.67', 'groupId': 'OG000'}, {'value': '30.93', 'spread': '7.45', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=273, 124)', 'categories': [{'measurements': [{'value': '30.58', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '30.87', 'spread': '7.19', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=289, 133)', 'categories': [{'measurements': [{'value': '30.64', 'spread': '6.86', 'groupId': 'OG000'}, {'value': '31.02', 'spread': '7.47', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=146, 60)', 'categories': [{'measurements': [{'value': '30.40', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '29.37', 'spread': '7.07', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=288, 128)', 'categories': [{'measurements': [{'value': '30.51', 'spread': '6.76', 'groupId': 'OG000'}, {'value': '31.23', 'spread': '7.46', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=278, 125)', 'categories': [{'measurements': [{'value': '30.70', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '30.90', 'spread': '7.30', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 124)', 'categories': [{'measurements': [{'value': '30.54', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '31.27', 'spread': '7.42', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 54)', 'categories': [{'measurements': [{'value': '29.80', 'spread': '6.72', 'groupId': 'OG000'}, {'value': '30.66', 'spread': '7.61', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=84, 38)', 'categories': [{'measurements': [{'value': '28.80', 'spread': '5.77', 'groupId': 'OG000'}, {'value': '29.74', 'spread': '5.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=370, 157)', 'categories': [{'measurements': [{'value': '9.70', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '6.61', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=362, 156)', 'categories': [{'measurements': [{'value': '10.51', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '9.91', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 155)', 'categories': [{'measurements': [{'value': '10.27', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '10.53', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 153)', 'categories': [{'measurements': [{'value': '10.46', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '10.74', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 146)', 'categories': [{'measurements': [{'value': '10.71', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '10.36', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=323, 145)', 'categories': [{'measurements': [{'value': '10.79', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '10.41', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 139)', 'categories': [{'measurements': [{'value': '10.30', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '9.87', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 136)', 'categories': [{'measurements': [{'value': '11.05', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '10.78', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=308, 137)', 'categories': [{'measurements': [{'value': '10.83', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '11.07', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=273, 124)', 'categories': [{'measurements': [{'value': '11.02', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '11.20', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=289, 133)', 'categories': [{'measurements': [{'value': '10.40', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '11.34', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=146, 60)', 'categories': [{'measurements': [{'value': '9.81', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '10.81', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=288, 128)', 'categories': [{'measurements': [{'value': '11.12', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '10.68', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=278, 125)', 'categories': [{'measurements': [{'value': '10.76', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '11.05', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 124)', 'categories': [{'measurements': [{'value': '10.81', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '10.09', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 54)', 'categories': [{'measurements': [{'value': '11.69', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '9.65', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=84, 38)', 'categories': [{'measurements': [{'value': '9.69', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '11.39', 'spread': '1.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=370, 157)', 'categories': [{'measurements': [{'value': '41.40', 'spread': '11.35', 'groupId': 'OG000'}, {'value': '40.56', 'spread': '11.18', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=362, 156)', 'categories': [{'measurements': [{'value': '41.20', 'spread': '11.29', 'groupId': 'OG000'}, {'value': '40.47', 'spread': '11.11', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 156)', 'categories': [{'measurements': [{'value': '41.28', 'spread': '11.20', 'groupId': 'OG000'}, {'value': '40.53', 'spread': '11.25', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 153)', 'categories': [{'measurements': [{'value': '41.23', 'spread': '11.28', 'groupId': 'OG000'}, {'value': '40.67', 'spread': '11.26', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=338, 146)', 'categories': [{'measurements': [{'value': '41.21', 'spread': '11.28', 'groupId': 'OG000'}, {'value': '40.24', 'spread': '11.11', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=323, 145)', 'categories': [{'measurements': [{'value': '41.23', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '40.19', 'spread': '11.20', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 139)', 'categories': [{'measurements': [{'value': '41.36', 'spread': '11.41', 'groupId': 'OG000'}, {'value': '40.28', 'spread': '11.33', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 136)', 'categories': [{'measurements': [{'value': '41.40', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '40.32', 'spread': '11.45', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=308, 137)', 'categories': [{'measurements': [{'value': '41.40', 'spread': '11.25', 'groupId': 'OG000'}, {'value': '40.33', 'spread': '11.41', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=273, 124)', 'categories': [{'measurements': [{'value': '41.28', 'spread': '11.47', 'groupId': 'OG000'}, {'value': '40.19', 'spread': '11.06', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=289, 133)', 'categories': [{'measurements': [{'value': '41.29', 'spread': '11.45', 'groupId': 'OG000'}, {'value': '40.26', 'spread': '11.50', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=146, 60)', 'categories': [{'measurements': [{'value': '42.11', 'spread': '11.81', 'groupId': 'OG000'}, {'value': '39.99', 'spread': '10.83', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=288, 128)', 'categories': [{'measurements': [{'value': '41.35', 'spread': '11.45', 'groupId': 'OG000'}, {'value': '40.06', 'spread': '11.35', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=278, 125)', 'categories': [{'measurements': [{'value': '41.25', 'spread': '11.60', 'groupId': 'OG000'}, {'value': '40.16', 'spread': '11.44', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 124)', 'categories': [{'measurements': [{'value': '41.39', 'spread': '11.60', 'groupId': 'OG000'}, {'value': '40.03', 'spread': '11.23', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 54)', 'categories': [{'measurements': [{'value': '41.73', 'spread': '11.58', 'groupId': 'OG000'}, {'value': '39.61', 'spread': '9.98', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=84, 38)', 'categories': [{'measurements': [{'value': '42.00', 'spread': '11.97', 'groupId': 'OG000'}, {'value': '37.55', 'spread': '9.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=370, 157)', 'categories': [{'measurements': [{'value': '7.29', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=362, 156)', 'categories': [{'measurements': [{'value': '6.84', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '7.73', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 156)', 'categories': [{'measurements': [{'value': '7.30', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '7.20', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 153)', 'categories': [{'measurements': [{'value': '7.15', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 146)', 'categories': [{'measurements': [{'value': '7.31', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '8.07', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=323, 145)', 'categories': [{'measurements': [{'value': '6.98', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '7.15', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 139)', 'categories': [{'measurements': [{'value': '7.26', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '8.54', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 136)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '7.76', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=308, 137)', 'categories': [{'measurements': [{'value': '7.79', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '6.09', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=273, 124)', 'categories': [{'measurements': [{'value': '6.93', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '7.65', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=289, 133)', 'categories': [{'measurements': [{'value': '7.33', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '7.04', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=146, 60)', 'categories': [{'measurements': [{'value': '6.37', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '7.42', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=288, 128)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '7.19', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=278, 125)', 'categories': [{'measurements': [{'value': '6.60', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '6.99', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 124)', 'categories': [{'measurements': [{'value': '6.75', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '9.08', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 54)', 'categories': [{'measurements': [{'value': '5.53', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '8.74', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=84, 38)', 'categories': [{'measurements': [{'value': '5.28', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '9.91', 'spread': '1.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Physical Function Component of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=373, 160)', 'categories': [{'measurements': [{'value': '28.79', 'spread': '9.12', 'groupId': 'OG000'}, {'value': '28.09', 'spread': '8.88', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=367, 157)', 'categories': [{'measurements': [{'value': '28.62', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '28.07', 'spread': '8.95', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 157)', 'categories': [{'measurements': [{'value': '28.63', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '28.05', 'spread': '8.91', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 155)', 'categories': [{'measurements': [{'value': '28.71', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '28.02', 'spread': '8.91', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort(n=338, 148)', 'categories': [{'measurements': [{'value': '28.68', 'spread': '9.20', 'groupId': 'OG000'}, {'value': '28.01', 'spread': '8.93', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=324, 147)', 'categories': [{'measurements': [{'value': '28.41', 'spread': '8.97', 'groupId': 'OG000'}, {'value': '28.01', 'spread': '9.01', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 140)', 'categories': [{'measurements': [{'value': '28.36', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '27.93', 'spread': '9.11', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 137)', 'categories': [{'measurements': [{'value': '28.43', 'spread': '9.01', 'groupId': 'OG000'}, {'value': '28.10', 'spread': '9.15', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=310, 138)', 'categories': [{'measurements': [{'value': '28.43', 'spread': '8.98', 'groupId': 'OG000'}, {'value': '28.10', 'spread': '9.11', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=275, 125)', 'categories': [{'measurements': [{'value': '28.70', 'spread': '8.95', 'groupId': 'OG000'}, {'value': '27.91', 'spread': '8.85', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=292, 135)', 'categories': [{'measurements': [{'value': '28.62', 'spread': '9.12', 'groupId': 'OG000'}, {'value': '28.17', 'spread': '9.13', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=147, 61)', 'categories': [{'measurements': [{'value': '28.70', 'spread': '8.97', 'groupId': 'OG000'}, {'value': '26.49', 'spread': '8.34', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=290, 129)', 'categories': [{'measurements': [{'value': '28.35', 'spread': '9.11', 'groupId': 'OG000'}, {'value': '28.24', 'spread': '9.03', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=279, 126)', 'categories': [{'measurements': [{'value': '28.68', 'spread': '9.10', 'groupId': 'OG000'}, {'value': '27.98', 'spread': '8.87', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 125)', 'categories': [{'measurements': [{'value': '28.50', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '28.50', 'spread': '9.03', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 55)', 'categories': [{'measurements': [{'value': '27.78', 'spread': '8.86', 'groupId': 'OG000'}, {'value': '27.75', 'spread': '9.35', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=85, 38)', 'categories': [{'measurements': [{'value': '26.94', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '26.25', 'spread': '7.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '529', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX OL', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Body Temperature', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Heart Rate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blood Pressure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.', 'description': 'Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants entering the OL period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing AEs of Special Interest in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '529', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX OL', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Infections/Infestations', 'categories': [{'measurements': [{'value': '452', 'groupId': 'OG000'}]}]}, {'title': 'Neoplasms', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Autoimmune Disorders', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Acute Infusional AEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Peri-Infusional AEs', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period.'}, {'type': 'PRIMARY', 'title': 'Mean BL Hematocrit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '38.79', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '39.38', 'spread': '4.32', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '38.72', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '39.39', 'spread': '4.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '38.69', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '39.46', 'spread': '4.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '38.59', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '39.40', 'spread': '4.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '38.70', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '39.48', 'spread': '4.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '38.11', 'spread': '4.56', 'groupId': 'OG000'}, {'value': '39.83', 'spread': '3.90', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '38.07', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '39.99', 'spread': '4.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '37.11', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '39.12', 'spread': '3.45', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '37.25', 'spread': '3.83', 'groupId': 'OG000'}, {'value': '39.02', 'spread': '3.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.', 'unitOfMeasure': 'Percentage of Red Blood Cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean Change From BL in Participant Hematocrit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '2.16', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.85', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '1.79', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.', 'unitOfMeasure': 'Percentage Blood Volume Occupied by RBCs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean BL Platelet Count in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '352.7', 'spread': '108.5', 'groupId': 'OG000'}, {'value': '339.2', 'spread': '97.92', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '351.8', 'spread': '110.4', 'groupId': 'OG000'}, {'value': '334.2', 'spread': '91.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '351.7', 'spread': '107.9', 'groupId': 'OG000'}, {'value': '334.8', 'spread': '96.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '352.7', 'spread': '106.4', 'groupId': 'OG000'}, {'value': '335.0', 'spread': '98.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '351.1', 'spread': '98.28', 'groupId': 'OG000'}, {'value': '334.2', 'spread': '97.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '365.7', 'spread': '113.9', 'groupId': 'OG000'}, {'value': '333.7', 'spread': '89.66', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '366.1', 'spread': '115.3', 'groupId': 'OG000'}, {'value': '326.6', 'spread': '86.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '375.2', 'spread': '118.6', 'groupId': 'OG000'}, {'value': '321.2', 'spread': '90.51', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '380.4', 'spread': '119.7', 'groupId': 'OG000'}, {'value': '320.3', 'spread': '91.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.', 'unitOfMeasure': '10^9 c/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean Change From BL in Participant Platelet Count in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-66.9', 'spread': '4.29', 'groupId': 'OG000'}, {'value': '-29.9', 'spread': '5.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-59.5', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '-45.4', 'spread': '6.64', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-53.5', 'spread': '5.10', 'groupId': 'OG000'}, {'value': '-36.8', 'spread': '7.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-59.0', 'spread': '5.64', 'groupId': 'OG000'}, {'value': '-48.7', 'spread': '7.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-68.9', 'spread': '4.92', 'groupId': 'OG000'}, {'value': '-59.2', 'spread': '7.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-55.1', 'spread': '14.57', 'groupId': 'OG000'}, {'value': '-47.5', 'spread': '10.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-63.7', 'spread': '8.33', 'groupId': 'OG000'}, {'value': '-50.3', 'spread': '9.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-69.6', 'spread': '10.64', 'groupId': 'OG000'}, {'value': '-55.3', 'spread': '11.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-80.5', 'spread': '10.68', 'groupId': 'OG000'}, {'value': '-53.9', 'spread': '10.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.', 'unitOfMeasure': '10^9 c/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Hemoglobin Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '12.49', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '12.70', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '7.23', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '7.35', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '4.03', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '12.50', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '12.72', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '7.22', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '7.34', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '4.01', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '12.48', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '12.75', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '7.23', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '7.34', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '4.02', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '4.11', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '12.46', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '12.74', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '7.23', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '7.35', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '4.02', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '12.49', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '12.79', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '7.23', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '7.37', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '4.02', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '12.35', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '12.88', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '7.27', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '7.35', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '4.03', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '12.35', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '12.98', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '7.25', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '7.38', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '4.03', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '12.21', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '12.84', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '7.18', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '7.27', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '3.98', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '4.08', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '12.25', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '12.82', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '7.18', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '7.28', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '3.97', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '4.08', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Hemoglobin Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=373, 160)', 'categories': [{'measurements': [{'value': '8.61', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '6.44', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=367, 157)', 'categories': [{'measurements': [{'value': '9.44', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '9.13', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 157)', 'categories': [{'measurements': [{'value': '9.43', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '9.46', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 155)', 'categories': [{'measurements': [{'value': '9.43', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '9.80', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 148)', 'categories': [{'measurements': [{'value': '9.51', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '9.63', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=324, 147)', 'categories': [{'measurements': [{'value': '10.17', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '9.71', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 140)', 'categories': [{'measurements': [{'value': '9.95', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '9.39', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 137)', 'categories': [{'measurements': [{'value': '10.23', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '10.45', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=310, 138)', 'categories': [{'measurements': [{'value': '9.40', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '10.35', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=275, 125)', 'categories': [{'measurements': [{'value': '9.74', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '10.57', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=292, 135)', 'categories': [{'measurements': [{'value': '9.95', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '9.92', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=147, 61)', 'categories': [{'measurements': [{'value': '9.18', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '10.75', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=290, 129)', 'categories': [{'measurements': [{'value': '10.55', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '10.03', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=279, 126)', 'categories': [{'measurements': [{'value': '9.80', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '9.68', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 125)', 'categories': [{'measurements': [{'value': '9.48', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '9.08', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 55)', 'categories': [{'measurements': [{'value': '11.35', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '9.22', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=85, 38)', 'categories': [{'measurements': [{'value': '10.06', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '10.90', 'spread': '2.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=372, 160)', 'categories': [{'measurements': [{'value': '32.06', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '32.08', 'spread': '7.34', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=367, 157)', 'categories': [{'measurements': [{'value': '31.88', 'spread': '7.64', 'groupId': 'OG000'}, {'value': '32.02', 'spread': '7.40', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 157)', 'categories': [{'measurements': [{'value': '32.02', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '32.11', 'spread': '7.39', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 156)', 'categories': [{'measurements': [{'value': '32.04', 'spread': '7.81', 'groupId': 'OG000'}, {'value': '32.14', 'spread': '7.41', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=338, 148)', 'categories': [{'measurements': [{'value': '32.12', 'spread': '7.86', 'groupId': 'OG000'}, {'value': '31.79', 'spread': '6.83', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=324, 147)', 'categories': [{'measurements': [{'value': '31.93', 'spread': '7.65', 'groupId': 'OG000'}, {'value': '31.91', 'spread': '7.14', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 140)', 'categories': [{'measurements': [{'value': '31.91', 'spread': '7.56', 'groupId': 'OG000'}, {'value': '32.01', 'spread': '7.27', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 137)', 'categories': [{'measurements': [{'value': '31.83', 'spread': '7.52', 'groupId': 'OG000'}, {'value': '32.05', 'spread': '7.32', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=309, 138)', 'categories': [{'measurements': [{'value': '31.82', 'spread': '7.52', 'groupId': 'OG000'}, {'value': '32.02', 'spread': '7.31', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=275, 125)', 'categories': [{'measurements': [{'value': '31.84', 'spread': '7.55', 'groupId': 'OG000'}, {'value': '31.88', 'spread': '7.22', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=292, 134)', 'categories': [{'measurements': [{'value': '31.83', 'spread': '7.56', 'groupId': 'OG000'}, {'value': '32.09', 'spread': '7.38', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=147, 61)', 'categories': [{'measurements': [{'value': '31.90', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '31.66', 'spread': '6.53', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=289, 129)', 'categories': [{'measurements': [{'value': '31.82', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '32.08', 'spread': '7.34', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=279, 126)', 'categories': [{'measurements': [{'value': '31.88', 'spread': '7.60', 'groupId': 'OG000'}, {'value': '31.96', 'spread': '7.25', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 125)', 'categories': [{'measurements': [{'value': '31.87', 'spread': '7.71', 'groupId': 'OG000'}, {'value': '31.71', 'spread': '6.95', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 55)', 'categories': [{'measurements': [{'value': '31.79', 'spread': '7.72', 'groupId': 'OG000'}, {'value': '31.43', 'spread': '6.92', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=84, 38)', 'categories': [{'measurements': [{'value': '30.98', 'spread': '6.88', 'groupId': 'OG000'}, {'value': '30.56', 'spread': '5.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=372, 160)', 'categories': [{'measurements': [{'value': '10.10', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '7.59', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=367, 157)', 'categories': [{'measurements': [{'value': '10.66', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '10.89', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 157)', 'categories': [{'measurements': [{'value': '11.18', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '10.98', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 156)', 'categories': [{'measurements': [{'value': '10.93', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '11.61', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 148)', 'categories': [{'measurements': [{'value': '11.33', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '11.50', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=324, 147)', 'categories': [{'measurements': [{'value': '10.56', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '10.57', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 140)', 'categories': [{'measurements': [{'value': '10.13', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '10.96', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 137)', 'categories': [{'measurements': [{'value': '10.96', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '10.88', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=309, 138)', 'categories': [{'measurements': [{'value': '11.82', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '9.72', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=275, 125)', 'categories': [{'measurements': [{'value': '11.32', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '11.09', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=292, 134)', 'categories': [{'measurements': [{'value': '10.25', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '11.61', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=147, 61)', 'categories': [{'measurements': [{'value': '9.09', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '10.32', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=289, 129)', 'categories': [{'measurements': [{'value': '10.57', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '11.39', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=279, 126)', 'categories': [{'measurements': [{'value': '10.11', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '11.10', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 125)', 'categories': [{'measurements': [{'value': '11.25', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '10.62', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 55)', 'categories': [{'measurements': [{'value': '10.79', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '10.42', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=84, 38)', 'categories': [{'measurements': [{'value': '9.04', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '12.84', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=373, 160)', 'categories': [{'measurements': [{'value': '33.13', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '33.43', 'spread': '7.53', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=367, 157)', 'categories': [{'measurements': [{'value': '32.95', 'spread': '7.36', 'groupId': 'OG000'}, {'value': '33.47', 'spread': '7.56', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 157)', 'categories': [{'measurements': [{'value': '33.05', 'spread': '7.36', 'groupId': 'OG000'}, {'value': '33.27', 'spread': '7.49', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 156)', 'categories': [{'measurements': [{'value': '33.00', 'spread': '7.30', 'groupId': 'OG000'}, {'value': '33.49', 'spread': '7.59', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=338, 148)', 'categories': [{'measurements': [{'value': '32.94', 'spread': '7.38', 'groupId': 'OG000'}, {'value': '33.44', 'spread': '7.57', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=324, 147)', 'categories': [{'measurements': [{'value': '32.80', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '33.53', 'spread': '7.65', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 140)', 'categories': [{'measurements': [{'value': '32.80', 'spread': '7.33', 'groupId': 'OG000'}, {'value': '33.29', 'spread': '7.67', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 137)', 'categories': [{'measurements': [{'value': '32.79', 'spread': '7.28', 'groupId': 'OG000'}, {'value': '33.29', 'spread': '7.74', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=309, 138)', 'categories': [{'measurements': [{'value': '32.88', 'spread': '7.30', 'groupId': 'OG000'}, {'value': '33.29', 'spread': '7.71', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=275, 125)', 'categories': [{'measurements': [{'value': '32.84', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '33.13', 'spread': '7.71', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=291, 134)', 'categories': [{'measurements': [{'value': '32.81', 'spread': '7.50', 'groupId': 'OG000'}, {'value': '33.31', 'spread': '7.77', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=147, 61)', 'categories': [{'measurements': [{'value': '32.57', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '31.83', 'spread': '6.61', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=289, 129)', 'categories': [{'measurements': [{'value': '32.73', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '33.48', 'spread': '7.74', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=279, 126)', 'categories': [{'measurements': [{'value': '32.78', 'spread': '7.36', 'groupId': 'OG000'}, {'value': '33.20', 'spread': '7.52', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 125)', 'categories': [{'measurements': [{'value': '32.85', 'spread': '7.44', 'groupId': 'OG000'}, {'value': '33.56', 'spread': '7.71', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 55)', 'categories': [{'measurements': [{'value': '31.98', 'spread': '7.20', 'groupId': 'OG000'}, {'value': '32.81', 'spread': '7.66', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=85, 38)', 'categories': [{'measurements': [{'value': '31.49', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '31.40', 'spread': '5.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AlAll treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=373, 160)', 'categories': [{'measurements': [{'value': '12.08', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=367, 157)', 'categories': [{'measurements': [{'value': '12.38', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '11.78', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 157)', 'categories': [{'measurements': [{'value': '11.94', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '12.53', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 156)', 'categories': [{'measurements': [{'value': '12.52', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '11.97', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 148)', 'categories': [{'measurements': [{'value': '12.84', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '12.06', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=324, 147)', 'categories': [{'measurements': [{'value': '13.13', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '12.25', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 140)', 'categories': [{'measurements': [{'value': '12.44', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '11.84', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 137)', 'categories': [{'measurements': [{'value': '12.86', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '12.87', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=309, 138)', 'categories': [{'measurements': [{'value': '13.34', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '12.93', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=275, 125)', 'categories': [{'measurements': [{'value': '13.21', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '13.44', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=291, 134)', 'categories': [{'measurements': [{'value': '12.83', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '13.31', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=147, 61)', 'categories': [{'measurements': [{'value': '12.44', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '13.40', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=289, 129)', 'categories': [{'measurements': [{'value': '13.13', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '11.74', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=279, 126)', 'categories': [{'measurements': [{'value': '12.89', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '13.36', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 125)', 'categories': [{'measurements': [{'value': '12.56', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '12.65', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 55)', 'categories': [{'measurements': [{'value': '13.45', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '13.19', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=85, 38)', 'categories': [{'measurements': [{'value': '10.44', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '14.28', 'spread': '1.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL General Health Component of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=373, 160)', 'categories': [{'measurements': [{'value': '35.43', 'spread': '8.41', 'groupId': 'OG000'}, {'value': '35.27', 'spread': '7.73', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=367, 157)', 'categories': [{'measurements': [{'value': '35.33', 'spread': '8.45', 'groupId': 'OG000'}, {'value': '35.28', 'spread': '7.80', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 157)', 'categories': [{'measurements': [{'value': '35.34', 'spread': '8.40', 'groupId': 'OG000'}, {'value': '35.17', 'spread': '7.73', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 156)', 'categories': [{'measurements': [{'value': '35.41', 'spread': '8.38', 'groupId': 'OG000'}, {'value': '35.21', 'spread': '7.72', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=338, 148)', 'categories': [{'measurements': [{'value': '35.47', 'spread': '8.46', 'groupId': 'OG000'}, {'value': '35.16', 'spread': '7.61', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=324, 147)', 'categories': [{'measurements': [{'value': '35.59', 'spread': '8.45', 'groupId': 'OG000'}, {'value': '35.19', 'spread': '7.62', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 140)', 'categories': [{'measurements': [{'value': '35.72', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '35.22', 'spread': '7.78', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 137)', 'categories': [{'measurements': [{'value': '35.67', 'spread': '8.46', 'groupId': 'OG000'}, {'value': '35.38', 'spread': '7.79', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=312, 138)', 'categories': [{'measurements': [{'value': '35.69', 'spread': '8.52', 'groupId': 'OG000'}, {'value': '35.32', 'spread': '7.80', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=275, 125)', 'categories': [{'measurements': [{'value': '35.50', 'spread': '8.38', 'groupId': 'OG000'}, {'value': '35.54', 'spread': '7.87', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=291, 135)', 'categories': [{'measurements': [{'value': '35.65', 'spread': '8.38', 'groupId': 'OG000'}, {'value': '35.31', 'spread': '7.88', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=147, 61)', 'categories': [{'measurements': [{'value': '35.88', 'spread': '8.68', 'groupId': 'OG000'}, {'value': '33.78', 'spread': '7.96', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=290, 129)', 'categories': [{'measurements': [{'value': '35.56', 'spread': '8.48', 'groupId': 'OG000'}, {'value': '35.43', 'spread': '7.85', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=280, 126)', 'categories': [{'measurements': [{'value': '35.67', 'spread': '8.33', 'groupId': 'OG000'}, {'value': '35.23', 'spread': '7.91', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 125)', 'categories': [{'measurements': [{'value': '35.61', 'spread': '8.46', 'groupId': 'OG000'}, {'value': '35.56', 'spread': '7.83', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=119, 55)', 'categories': [{'measurements': [{'value': '34.87', 'spread': '8.65', 'groupId': 'OG000'}, {'value': '34.94', 'spread': '8.67', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=85, 38)', 'categories': [{'measurements': [{'value': '34.29', 'spread': '9.03', 'groupId': 'OG000'}, {'value': '33.71', 'spread': '8.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=373, 160)', 'categories': [{'measurements': [{'value': '6.88', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '5.43', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=367, 157)', 'categories': [{'measurements': [{'value': '6.94', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '7.32', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 157)', 'categories': [{'measurements': [{'value': '6.82', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '7.88', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 156)', 'categories': [{'measurements': [{'value': '7.22', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '7.87', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 148)', 'categories': [{'measurements': [{'value': '7.31', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '7.90', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=324, 147)', 'categories': [{'measurements': [{'value': '6.89', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '7.63', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 140)', 'categories': [{'measurements': [{'value': '6.86', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '8.24', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 137)', 'categories': [{'measurements': [{'value': '7.31', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '8.45', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '7.24', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '8.36', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=275, 125)', 'categories': [{'measurements': [{'value': '7.48', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '8.55', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=291, 135)', 'categories': [{'measurements': [{'value': '7.18', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '8.17', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=147, 61)', 'categories': [{'measurements': [{'value': '6.19', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '8.45', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=290, 129)', 'categories': [{'measurements': [{'value': '7.07', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '8.32', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=280, 126)', 'categories': [{'measurements': [{'value': '7.27', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '8.10', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 125)', 'categories': [{'measurements': [{'value': '7.50', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '7.53', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=119, 55)', 'categories': [{'measurements': [{'value': '6.55', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '7.05', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=85, 38)', 'categories': [{'measurements': [{'value': '5.93', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '8.76', 'spread': '1.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=373, 160)', 'categories': [{'measurements': [{'value': '35.58', 'spread': '10.10', 'groupId': 'OG000'}, {'value': '34.98', 'spread': '9.72', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=368, 157)', 'categories': [{'measurements': [{'value': '35.42', 'spread': '10.13', 'groupId': 'OG000'}, {'value': '34.91', 'spread': '9.75', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 157)', 'categories': [{'measurements': [{'value': '35.52', 'spread': '10.18', 'groupId': 'OG000'}, {'value': '34.94', 'spread': '9.80', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 156)', 'categories': [{'measurements': [{'value': '35.46', 'spread': '10.14', 'groupId': 'OG000'}, {'value': '35.01', 'spread': '9.80', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=338, 148)', 'categories': [{'measurements': [{'value': '35.70', 'spread': '10.24', 'groupId': 'OG000'}, {'value': '34.51', 'spread': '9.61', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=324, 147)', 'categories': [{'measurements': [{'value': '35.47', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '34.57', 'spread': '9.73', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 140)', 'categories': [{'measurements': [{'value': '35.47', 'spread': '10.20', 'groupId': 'OG000'}, {'value': '34.65', 'spread': '9.82', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 137)', 'categories': [{'measurements': [{'value': '35.46', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '34.67', 'spread': '9.90', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=312, 138)', 'categories': [{'measurements': [{'value': '35.60', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '34.68', 'spread': '9.86', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=275, 125)', 'categories': [{'measurements': [{'value': '35.52', 'spread': '10.10', 'groupId': 'OG000'}, {'value': '34.51', 'spread': '9.60', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=292, 134)', 'categories': [{'measurements': [{'value': '35.48', 'spread': '10.24', 'groupId': 'OG000'}, {'value': '34.82', 'spread': '9.93', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=147, 62)', 'categories': [{'measurements': [{'value': '35.65', 'spread': '10.53', 'groupId': 'OG000'}, {'value': '33.24', 'spread': '9.09', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=289, 129)', 'categories': [{'measurements': [{'value': '35.56', 'spread': '10.28', 'groupId': 'OG000'}, {'value': '34.83', 'spread': '9.82', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=280, 126)', 'categories': [{'measurements': [{'value': '35.44', 'spread': '10.45', 'groupId': 'OG000'}, {'value': '34.73', 'spread': '9.90', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 125)', 'categories': [{'measurements': [{'value': '35.56', 'spread': '10.42', 'groupId': 'OG000'}, {'value': '34.86', 'spread': '9.52', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 55)', 'categories': [{'measurements': [{'value': '34.50', 'spread': '10.41', 'groupId': 'OG000'}, {'value': '33.75', 'spread': '8.92', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=85, 38)', 'categories': [{'measurements': [{'value': '34.66', 'spread': '10.43', 'groupId': 'OG000'}, {'value': '31.85', 'spread': '8.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=373, 160)', 'categories': [{'measurements': [{'value': '9.01', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '7.12', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=368, 157)', 'categories': [{'measurements': [{'value': '9.74', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 157)', 'categories': [{'measurements': [{'value': '9.88', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '9.44', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 156)', 'categories': [{'measurements': [{'value': '9.48', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '8.66', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 148)', 'categories': [{'measurements': [{'value': '9.99', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '9.90', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=324, 147)', 'categories': [{'measurements': [{'value': '9.80', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '8.97', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 140)', 'categories': [{'measurements': [{'value': '9.96', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '9.81', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 137)', 'categories': [{'measurements': [{'value': '9.71', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '9.51', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '10.16', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '8.61', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=275, 125)', 'categories': [{'measurements': [{'value': '9.28', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '9.64', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=292, 134)', 'categories': [{'measurements': [{'value': '9.54', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '9.92', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=147, 62)', 'categories': [{'measurements': [{'value': '9.01', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '8.84', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=289, 129)', 'categories': [{'measurements': [{'value': '10.16', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '9.26', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=280, 126)', 'categories': [{'measurements': [{'value': '9.67', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '9.05', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 125)', 'categories': [{'measurements': [{'value': '8.93', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '8.16', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 55)', 'categories': [{'measurements': [{'value': '9.34', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '10.17', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=85, 38)', 'categories': [{'measurements': [{'value': '7.98', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '10.57', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n= 370, 158)', 'categories': [{'measurements': [{'value': '35.78', 'spread': '13.63', 'groupId': 'OG000'}, {'value': '33.40', 'spread': '12.53', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=365, 157)', 'categories': [{'measurements': [{'value': '35.71', 'spread': '13.61', 'groupId': 'OG000'}, {'value': '33.26', 'spread': '12.44', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 156)', 'categories': [{'measurements': [{'value': '35.61', 'spread': '13.57', 'groupId': 'OG000'}, {'value': '33.39', 'spread': '12.61', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 155)', 'categories': [{'measurements': [{'value': '35.66', 'spread': '13.55', 'groupId': 'OG000'}, {'value': '33.52', 'spread': '12.60', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=338, 147)', 'categories': [{'measurements': [{'value': '35.49', 'spread': '13.49', 'groupId': 'OG000'}, {'value': '33.34', 'spread': '12.45', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=324, 146)', 'categories': [{'measurements': [{'value': '35.38', 'spread': '13.42', 'groupId': 'OG000'}, {'value': '33.26', 'spread': '12.52', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 139)', 'categories': [{'measurements': [{'value': '35.46', 'spread': '13.40', 'groupId': 'OG000'}, {'value': '33.13', 'spread': '12.60', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 136)', 'categories': [{'measurements': [{'value': '35.42', 'spread': '13.36', 'groupId': 'OG000'}, {'value': '33.19', 'spread': '12.65', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=309, 137)', 'categories': [{'measurements': [{'value': '35.40', 'spread': '13.36', 'groupId': 'OG000'}, {'value': '33.27', 'spread': '12.64', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=275, 124)', 'categories': [{'measurements': [{'value': '35.46', 'spread': '13.34', 'groupId': 'OG000'}, {'value': '33.42', 'spread': '12.57', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=291, 133)', 'categories': [{'measurements': [{'value': '35.61', 'spread': '13.44', 'groupId': 'OG000'}, {'value': '33.00', 'spread': '12.51', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=146, 60)', 'categories': [{'measurements': [{'value': '36.00', 'spread': '13.78', 'groupId': 'OG000'}, {'value': '32.69', 'spread': '12.39', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=289, 128)', 'categories': [{'measurements': [{'value': '35.36', 'spread': '13.44', 'groupId': 'OG000'}, {'value': '32.79', 'spread': '12.31', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=279, 125)', 'categories': [{'measurements': [{'value': '35.33', 'spread': '13.39', 'groupId': 'OG000'}, {'value': '32.92', 'spread': '12.48', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 124)', 'categories': [{'measurements': [{'value': '35.43', 'spread': '13.50', 'groupId': 'OG000'}, {'value': '32.74', 'spread': '12.14', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 54)', 'categories': [{'measurements': [{'value': '35.61', 'spread': '13.67', 'groupId': 'OG000'}, {'value': '30.76', 'spread': '11.58', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=85, 38)', 'categories': [{'measurements': [{'value': '35.26', 'spread': '13.76', 'groupId': 'OG000'}, {'value': '29.28', 'spread': '10.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n= 370, 158)', 'categories': [{'measurements': [{'value': '8.97', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '8.60', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=365, 157)', 'categories': [{'measurements': [{'value': '8.02', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '10.80', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 156)', 'categories': [{'measurements': [{'value': '8.44', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '10.13', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 155)', 'categories': [{'measurements': [{'value': '8.60', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '10.47', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 147)', 'categories': [{'measurements': [{'value': '8.96', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '10.89', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=324, 146)', 'categories': [{'measurements': [{'value': '8.71', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '11.04', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 139)', 'categories': [{'measurements': [{'value': '8.48', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '11.67', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 136)', 'categories': [{'measurements': [{'value': '8.61', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '11.70', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=309, 137)', 'categories': [{'measurements': [{'value': '9.31', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '9.46', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=275, 124)', 'categories': [{'measurements': [{'value': '8.35', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '11.17', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=291, 133)', 'categories': [{'measurements': [{'value': '8.43', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '10.53', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=146, 60)', 'categories': [{'measurements': [{'value': '7.22', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '11.41', 'spread': '2.23', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=289, 128)', 'categories': [{'measurements': [{'value': '7.51', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '10.70', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=279, 125)', 'categories': [{'measurements': [{'value': '7.91', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '9.44', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 124)', 'categories': [{'measurements': [{'value': '7.39', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 54)', 'categories': [{'measurements': [{'value': '7.81', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '12.49', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=85, 38)', 'categories': [{'measurements': [{'value': '7.06', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '16.08', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Vitality Component of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=373, 159)', 'categories': [{'measurements': [{'value': '40.93', 'spread': '9.14', 'groupId': 'OG000'}, {'value': '41.29', 'spread': '8.35', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=368, 156)', 'categories': [{'measurements': [{'value': '40.77', 'spread': '9.11', 'groupId': 'OG000'}, {'value': '41.21', 'spread': '8.38', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 156)', 'categories': [{'measurements': [{'value': '40.68', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '41.21', 'spread': '8.40', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 155)', 'categories': [{'measurements': [{'value': '40.77', 'spread': '9.02', 'groupId': 'OG000'}, {'value': '41.40', 'spread': '8.37', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=338, 147)', 'categories': [{'measurements': [{'value': '40.74', 'spread': '9.11', 'groupId': 'OG000'}, {'value': '41.19', 'spread': '8.34', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=323, 146)', 'categories': [{'measurements': [{'value': '40.60', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '41.27', 'spread': '8.46', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 140)', 'categories': [{'measurements': [{'value': '40.79', 'spread': '9.11', 'groupId': 'OG000'}, {'value': '41.34', 'spread': '8.45', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 137)', 'categories': [{'measurements': [{'value': '40.85', 'spread': '9.00', 'groupId': 'OG000'}, {'value': '41.43', 'spread': '8.45', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=312, 138)', 'categories': [{'measurements': [{'value': '40.85', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '41.33', 'spread': '8.50', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=273, 125)', 'categories': [{'measurements': [{'value': '40.69', 'spread': '9.23', 'groupId': 'OG000'}, {'value': '41.23', 'spread': '8.42', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=292, 134)', 'categories': [{'measurements': [{'value': '40.78', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '41.31', 'spread': '8.57', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=147, 62)', 'categories': [{'measurements': [{'value': '41.30', 'spread': '9.39', 'groupId': 'OG000'}, {'value': '40.64', 'spread': '7.84', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=290, 129)', 'categories': [{'measurements': [{'value': '40.79', 'spread': '9.21', 'groupId': 'OG000'}, {'value': '41.47', 'spread': '8.17', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=280, 126)', 'categories': [{'measurements': [{'value': '40.84', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '41.23', 'spread': '8.29', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 125)', 'categories': [{'measurements': [{'value': '40.82', 'spread': '9.27', 'groupId': 'OG000'}, {'value': '41.47', 'spread': '8.36', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 55)', 'categories': [{'measurements': [{'value': '42.19', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '41.72', 'spread': '8.01', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=85, 38)', 'categories': [{'measurements': [{'value': '41.16', 'spread': '9.08', 'groupId': 'OG000'}, {'value': '39.88', 'spread': '8.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=373, 159)', 'categories': [{'measurements': [{'value': '8.58', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '6.04', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=368, 156)', 'categories': [{'measurements': [{'value': '8.29', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '8.70', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 156)', 'categories': [{'measurements': [{'value': '8.68', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '8.09', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 155)', 'categories': [{'measurements': [{'value': '8.61', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '8.46', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 147)', 'categories': [{'measurements': [{'value': '8.69', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '8.41', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=323, 146)', 'categories': [{'measurements': [{'value': '8.99', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '8.22', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 140)', 'categories': [{'measurements': [{'value': '8.69', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '8.53', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 137)', 'categories': [{'measurements': [{'value': '8.85', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '7.52', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '8.98', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '7.53', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=273, 125)', 'categories': [{'measurements': [{'value': '9.08', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '8.08', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=292, 134)', 'categories': [{'measurements': [{'value': '8.39', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '8.14', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=147, 62)', 'categories': [{'measurements': [{'value': '8.29', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '6.39', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=290, 129)', 'categories': [{'measurements': [{'value': '9.19', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '7.57', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=280, 126)', 'categories': [{'measurements': [{'value': '8.77', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '8.20', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 125)', 'categories': [{'measurements': [{'value': '8.96', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '7.42', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 55)', 'categories': [{'measurements': [{'value': '7.60', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '7.99', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=85, 38)', 'categories': [{'measurements': [{'value': '7.06', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '9.61', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Mental Health Component of the SF-36 by Visit in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=373, 159)', 'categories': [{'measurements': [{'value': '39.08', 'spread': '11.55', 'groupId': 'OG000'}, {'value': '39.43', 'spread': '11.09', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=368, 156)', 'categories': [{'measurements': [{'value': '38.87', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '39.33', 'spread': '11.14', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=355, 156)', 'categories': [{'measurements': [{'value': '38.89', 'spread': '11.44', 'groupId': 'OG000'}, {'value': '39.40', 'spread': '11.18', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=348, 155)', 'categories': [{'measurements': [{'value': '38.76', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '39.49', 'spread': '11.14', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=338, 147)', 'categories': [{'measurements': [{'value': '38.75', 'spread': '11.56', 'groupId': 'OG000'}, {'value': '39.05', 'spread': '11.18', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=323, 146)', 'categories': [{'measurements': [{'value': '38.85', 'spread': '11.57', 'groupId': 'OG000'}, {'value': '39.01', 'spread': '11.19', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=320, 140)', 'categories': [{'measurements': [{'value': '38.96', 'spread': '11.66', 'groupId': 'OG000'}, {'value': '39.03', 'spread': '11.35', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 137)', 'categories': [{'measurements': [{'value': '39.06', 'spread': '11.58', 'groupId': 'OG000'}, {'value': '39.09', 'spread': '11.46', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=312, 138)', 'categories': [{'measurements': [{'value': '39.16', 'spread': '11.47', 'groupId': 'OG000'}, {'value': '39.08', 'spread': '11.42', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=273, 125)', 'categories': [{'measurements': [{'value': '38.88', 'spread': '11.54', 'groupId': 'OG000'}, {'value': '38.67', 'spread': '11.22', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=292, 134)', 'categories': [{'measurements': [{'value': '38.81', 'spread': '11.56', 'groupId': 'OG000'}, {'value': '39.15', 'spread': '11.49', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=147, 62)', 'categories': [{'measurements': [{'value': '39.91', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '39.33', 'spread': '11.21', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=290, 129)', 'categories': [{'measurements': [{'value': '38.83', 'spread': '11.62', 'groupId': 'OG000'}, {'value': '38.93', 'spread': '11.42', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=280, 126)', 'categories': [{'measurements': [{'value': '38.88', 'spread': '11.66', 'groupId': 'OG000'}, {'value': '38.97', 'spread': '11.46', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=273, 125)', 'categories': [{'measurements': [{'value': '39.06', 'spread': '11.72', 'groupId': 'OG000'}, {'value': '38.95', 'spread': '11.44', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=118, 55)', 'categories': [{'measurements': [{'value': '38.95', 'spread': '10.99', 'groupId': 'OG000'}, {'value': '39.90', 'spread': '10.63', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=85, 38)', 'categories': [{'measurements': [{'value': '39.32', 'spread': '12.04', 'groupId': 'OG000'}, {'value': '37.40', 'spread': '10.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=373, 159)', 'categories': [{'measurements': [{'value': '7.02', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '5.31', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=368, 156)', 'categories': [{'measurements': [{'value': '7.27', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '6.45', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=355, 156)', 'categories': [{'measurements': [{'value': '7.72', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '6.49', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=348, 155)', 'categories': [{'measurements': [{'value': '7.60', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '6.03', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=338, 147)', 'categories': [{'measurements': [{'value': '7.49', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '7.38', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=323, 146)', 'categories': [{'measurements': [{'value': '7.26', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '5.72', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=320, 140)', 'categories': [{'measurements': [{'value': '7.65', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '7.29', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 137)', 'categories': [{'measurements': [{'value': '7.13', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '7.85', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '5.81', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=273, 125)', 'categories': [{'measurements': [{'value': '7.67', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '7.02', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=292, 134)', 'categories': [{'measurements': [{'value': '8.18', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '6.14', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=147, 62)', 'categories': [{'measurements': [{'value': '6.80', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '7.01', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=290, 129)', 'categories': [{'measurements': [{'value': '7.75', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '6.51', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=280, 126)', 'categories': [{'measurements': [{'value': '6.96', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '7.13', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=273, 125)', 'categories': [{'measurements': [{'value': '7.39', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=118, 55)', 'categories': [{'measurements': [{'value': '6.58', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '6.65', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=85, 38)', 'categories': [{'measurements': [{'value': '5.92', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '7.10', 'spread': '1.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Fatigue in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=373, 160)', 'categories': [{'measurements': [{'value': '63.52', 'spread': '23.23', 'groupId': 'OG000'}, {'value': '65.37', 'spread': '22.96', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=358, 156)', 'categories': [{'measurements': [{'value': '63.59', 'spread': '23.51', 'groupId': 'OG000'}, {'value': '65.28', 'spread': '23.24', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=353, 157)', 'categories': [{'measurements': [{'value': '63.25', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '65.78', 'spread': '22.89', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=339, 150)', 'categories': [{'measurements': [{'value': '63.19', 'spread': '23.48', 'groupId': 'OG000'}, {'value': '64.73', 'spread': '23.42', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=329, 143)', 'categories': [{'measurements': [{'value': '63.53', 'spread': '23.15', 'groupId': 'OG000'}, {'value': '64.59', 'spread': '23.73', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=318, 141)', 'categories': [{'measurements': [{'value': '63.77', 'spread': '22.77', 'groupId': 'OG000'}, {'value': '64.81', 'spread': '23.59', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=316, 139)', 'categories': [{'measurements': [{'value': '63.61', 'spread': '23.11', 'groupId': 'OG000'}, {'value': '65.36', 'spread': '23.29', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 137)', 'categories': [{'measurements': [{'value': '63.58', 'spread': '22.99', 'groupId': 'OG000'}, {'value': '65.51', 'spread': '23.43', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=307, 138)', 'categories': [{'measurements': [{'value': '63.33', 'spread': '23.18', 'groupId': 'OG000'}, {'value': '65.47', 'spread': '23.34', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=271, 123)', 'categories': [{'measurements': [{'value': '64.05', 'spread': '22.73', 'groupId': 'OG000'}, {'value': '65.18', 'spread': '23.11', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=289, 133)', 'categories': [{'measurements': [{'value': '63.38', 'spread': '23.37', 'groupId': 'OG000'}, {'value': '65.56', 'spread': '23.19', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=141, 59)', 'categories': [{'measurements': [{'value': '65.64', 'spread': '21.44', 'groupId': 'OG000'}, {'value': '69.00', 'spread': '20.57', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=283, 129)', 'categories': [{'measurements': [{'value': '63.66', 'spread': '23.51', 'groupId': 'OG000'}, {'value': '65.50', 'spread': '23.00', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=275, 124)', 'categories': [{'measurements': [{'value': '63.18', 'spread': '23.78', 'groupId': 'OG000'}, {'value': '66.34', 'spread': '22.48', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=263, 125)', 'categories': [{'measurements': [{'value': '62.48', 'spread': '23.84', 'groupId': 'OG000'}, {'value': '65.00', 'spread': '23.15', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=115, 53)', 'categories': [{'measurements': [{'value': '64.36', 'spread': '23.88', 'groupId': 'OG000'}, {'value': '67.45', 'spread': '22.16', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=81, 37)', 'categories': [{'measurements': [{'value': '64.77', 'spread': '22.45', 'groupId': 'OG000'}, {'value': '70.17', 'spread': '19.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in Fatigue in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=373, 160)', 'categories': [{'measurements': [{'value': '-28.0', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '-22.6', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=358, 156)', 'categories': [{'measurements': [{'value': '-28.5', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-31.1', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=353, 157)', 'categories': [{'measurements': [{'value': '-29.4', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '-31.1', 'spread': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=339, 150)', 'categories': [{'measurements': [{'value': '-30.4', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-30.5', 'spread': '2.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=329, 143)', 'categories': [{'measurements': [{'value': '-31.2', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-30.0', 'spread': '2.67', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=318, 141)', 'categories': [{'measurements': [{'value': '-29.9', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-31.0', 'spread': '2.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=316, 139)', 'categories': [{'measurements': [{'value': '-29.7', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '-30.6', 'spread': '2.45', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 137)', 'categories': [{'measurements': [{'value': '-30.5', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-31.1', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=307, 138)', 'categories': [{'measurements': [{'value': '-32.8', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '-31.3', 'spread': '2.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=271, 123)', 'categories': [{'measurements': [{'value': '-32.2', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-33.3', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=289, 133)', 'categories': [{'measurements': [{'value': '-30.3', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-31.2', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=141, 59)', 'categories': [{'measurements': [{'value': '-33.9', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-28.2', 'spread': '3.80', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=283, 129)', 'categories': [{'measurements': [{'value': '-32.2', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-32.6', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=275, 124)', 'categories': [{'measurements': [{'value': '-30.9', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-32.3', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=263, 125)', 'categories': [{'measurements': [{'value': '-30.3', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '-32.0', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=115, 53)', 'categories': [{'measurements': [{'value': '-33.6', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-33.7', 'spread': '4.18', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=81, 37)', 'categories': [{'measurements': [{'value': '-29.4', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '-35.0', 'spread': '4.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Sleep Quality in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=373, 160)', 'categories': [{'measurements': [{'value': '42.42', 'spread': '19.96', 'groupId': 'OG000'}, {'value': '43.53', 'spread': '19.59', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=358, 156)', 'categories': [{'measurements': [{'value': '42.77', 'spread': '20.07', 'groupId': 'OG000'}, {'value': '43.22', 'spread': '19.64', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=353, 157)', 'categories': [{'measurements': [{'value': '42.62', 'spread': '20.11', 'groupId': 'OG000'}, {'value': '43.24', 'spread': '19.39', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=339, 150)', 'categories': [{'measurements': [{'value': '42.51', 'spread': '20.19', 'groupId': 'OG000'}, {'value': '43.24', 'spread': '19.90', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=329, 143)', 'categories': [{'measurements': [{'value': '42.28', 'spread': '20.01', 'groupId': 'OG000'}, {'value': '43.97', 'spread': '19.75', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=318, 141)', 'categories': [{'measurements': [{'value': '42.63', 'spread': '20.07', 'groupId': 'OG000'}, {'value': '43.58', 'spread': '19.70', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=316, 139)', 'categories': [{'measurements': [{'value': '42.60', 'spread': '20.31', 'groupId': 'OG000'}, {'value': '43.65', 'spread': '19.83', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=312, 137)', 'categories': [{'measurements': [{'value': '42.51', 'spread': '20.25', 'groupId': 'OG000'}, {'value': '43.58', 'spread': '19.78', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=307, 138)', 'categories': [{'measurements': [{'value': '42.69', 'spread': '20.36', 'groupId': 'OG000'}, {'value': '43.78', 'spread': '19.84', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=270, 124)', 'categories': [{'measurements': [{'value': '43.08', 'spread': '20.28', 'groupId': 'OG000'}, {'value': '43.51', 'spread': '19.52', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=289, 133)', 'categories': [{'measurements': [{'value': '42.87', 'spread': '20.40', 'groupId': 'OG000'}, {'value': '43.76', 'spread': '19.83', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=141, 59)', 'categories': [{'measurements': [{'value': '41.78', 'spread': '21.79', 'groupId': 'OG000'}, {'value': '48.39', 'spread': '20.23', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=275, 124)', 'categories': [{'measurements': [{'value': '42.93', 'spread': '20.82', 'groupId': 'OG000'}, {'value': '44.14', 'spread': '19.74', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,625 Cohort (n=272, 122)', 'categories': [{'measurements': [{'value': '42.70', 'spread': '20.46', 'groupId': 'OG000'}, {'value': '44.51', 'spread': '20.00', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,821 Cohort (n=263, 125)', 'categories': [{'measurements': [{'value': '42.04', 'spread': '20.53', 'groupId': 'OG000'}, {'value': '43.59', 'spread': '20.00', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,989 Cohort (n=115, 53)', 'categories': [{'measurements': [{'value': '43.15', 'spread': '22.33', 'groupId': 'OG000'}, {'value': '47.62', 'spread': '20.33', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 2,185 Cohort (n=81, 37)', 'categories': [{'measurements': [{'value': '42.70', 'spread': '22.06', 'groupId': 'OG000'}, {'value': '51.43', 'spread': '19.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep \\[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in Sleep Quality in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=373, 160)', 'categories': [{'measurements': [{'value': '-10.8', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-7.97', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=358, 156)', 'categories': [{'measurements': [{'value': '-11.0', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-11.4', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=353, 157)', 'categories': [{'measurements': [{'value': '-11.4', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-10.9', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=339, 150)', 'categories': [{'measurements': [{'value': '-10.6', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-11.9', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=329, 143)', 'categories': [{'measurements': [{'value': '-10.9', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-11.3', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=318, 141)', 'categories': [{'measurements': [{'value': '-10.9', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-10.8', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=316, 139)', 'categories': [{'measurements': [{'value': '-12.2', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=312, 137)', 'categories': [{'measurements': [{'value': '-11.4', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-10.8', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=307, 138)', 'categories': [{'measurements': [{'value': '-11.9', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-11.3', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=270, 124)', 'categories': [{'measurements': [{'value': '-11.9', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-10.8', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=289, 133)', 'categories': [{'measurements': [{'value': '-12.2', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-10.1', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=141, 59)', 'categories': [{'measurements': [{'value': '-11.6', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=275, 124)', 'categories': [{'measurements': [{'value': '-11.7', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '1.62', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,625 (n=272, 122)', 'categories': [{'measurements': [{'value': '-11.2', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-11.6', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,821 (n=263, 125)', 'categories': [{'measurements': [{'value': '-10.8', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-9.10', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,989 (n=115, 53)', 'categories': [{'measurements': [{'value': '-11.7', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '2.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 2,185 (n=81, 37)', 'categories': [{'measurements': [{'value': '-8.76', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '2.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep \\[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Limitations on Activities of Daily Living in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'BL (Day 0) for Day 365 Cohort (n=360, 153)', 'categories': [{'measurements': [{'value': '13.80', 'spread': '10.98', 'groupId': 'OG000'}, {'value': '13.21', 'spread': '12.64', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 449 Cohort (n=348, 150)', 'categories': [{'measurements': [{'value': '13.82', 'spread': '10.92', 'groupId': 'OG000'}, {'value': '13.19', 'spread': '12.65', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 533 Cohort (n=338, 148)', 'categories': [{'measurements': [{'value': '13.91', 'spread': '11.06', 'groupId': 'OG000'}, {'value': '13.55', 'spread': '12.70', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 617 Cohort (n=332, 140)', 'categories': [{'measurements': [{'value': '14.01', 'spread': '11.10', 'groupId': 'OG000'}, {'value': '13.23', 'spread': '12.72', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 729 Cohort (n=316, 138)', 'categories': [{'measurements': [{'value': '13.96', 'spread': '11.11', 'groupId': 'OG000'}, {'value': '13.52', 'spread': '12.78', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 813 Cohort (n=306, 133)', 'categories': [{'measurements': [{'value': '14.31', 'spread': '11.14', 'groupId': 'OG000'}, {'value': '13.38', 'spread': '12.88', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 897 Cohort (n=302, 131)', 'categories': [{'measurements': [{'value': '14.08', 'spread': '11.14', 'groupId': 'OG000'}, {'value': '13.81', 'spread': '12.91', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 981 Cohort (n=300, 129)', 'categories': [{'measurements': [{'value': '14.13', 'spread': '11.19', 'groupId': 'OG000'}, {'value': '13.70', 'spread': '13.03', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,093 Cohort (n=292, 130)', 'categories': [{'measurements': [{'value': '14.34', 'spread': '11.15', 'groupId': 'OG000'}, {'value': '13.79', 'spread': '12.95', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,177 Cohort (n=259, 118)', 'categories': [{'measurements': [{'value': '14.53', 'spread': '11.17', 'groupId': 'OG000'}, {'value': '13.80', 'spread': '13.28', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,261 Cohort (n=231, 105)', 'categories': [{'measurements': [{'value': '15.00', 'spread': '11.01', 'groupId': 'OG000'}, {'value': '13.81', 'spread': '13.16', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,345 Cohort (n=133, 57)', 'categories': [{'measurements': [{'value': '15.71', 'spread': '11.20', 'groupId': 'OG000'}, {'value': '15.05', 'spread': '11.29', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 1,457 Cohort (n=196, 84)', 'categories': [{'measurements': [{'value': '15.36', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '14.87', 'spread': '13.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457', 'description': 'Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in Limitations on Activities of Daily Living in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'Day 365 (n=360, 153)', 'categories': [{'measurements': [{'value': '-9.04', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-6.39', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=348, 150)', 'categories': [{'measurements': [{'value': '-8.75', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-8.60', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=338, 148)', 'categories': [{'measurements': [{'value': '-9.21', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-9.00', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=332, 140)', 'categories': [{'measurements': [{'value': '-9.49', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-8.62', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=316, 138)', 'categories': [{'measurements': [{'value': '-9.55', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-8.18', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=306, 133)', 'categories': [{'measurements': [{'value': '-9.87', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-8.67', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=302, 131)', 'categories': [{'measurements': [{'value': '-9.35', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-9.22', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=300, 129)', 'categories': [{'measurements': [{'value': '-9.48', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-8.68', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,093 (n=292, 130)', 'categories': [{'measurements': [{'value': '-10.1', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-8.71', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,177 (n=259, 118)', 'categories': [{'measurements': [{'value': '-10.6', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-8.39', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,261 (n=231, 105)', 'categories': [{'measurements': [{'value': '-9.96', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-8.30', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,345 (n=133, 57)', 'categories': [{'measurements': [{'value': '-11.1', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '-9.18', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 1,457 (n=196, 84)', 'categories': [{'measurements': [{'value': '-9.73', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '1.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457', 'description': 'The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean BL White Blood Cells in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'White Blood Cells Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '8.78', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '8.81', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '6.45', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '6.39', 'spread': '2.67', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '8.89', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '8.73', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '6.50', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '2.66', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '8.81', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '8.80', 'spread': '3.08', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '6.46', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '2.71', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '8.80', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '8.74', 'spread': '3.10', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '6.43', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '6.32', 'spread': '2.73', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '8.82', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '8.70', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '6.45', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '2.72', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '9.14', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '8.80', 'spread': '2.91', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '6.78', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '9.16', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '8.81', 'spread': '2.93', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '6.86', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '2.74', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '9.64', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '9.22', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '7.25', 'spread': '2.90', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '2.99', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '9.73', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '9.22', 'spread': '3.16', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '7.35', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '6.93', 'spread': '3.03', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.', 'unitOfMeasure': '10^3 c/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean Change From BL in White Blood Cells in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'White Blood Cells Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-.10', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-1.35', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-1.50', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-1.50', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.55', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-1.57', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-1.44', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-1.56', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.71', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-1.72', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.92', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-1.30', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-.152', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-1.00', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-1.57', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-2.17', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-1.41', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-1.96', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophils Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-1.78', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-2.39', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Eosinophils Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Monocytes Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.', 'unitOfMeasure': '10^3 c/uL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean BL Liver Function Parameters in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Alkaline Phosphatase Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '99.56', 'spread': '37.11', 'groupId': 'OG000'}, {'value': '98.73', 'spread': '41.23', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '22.35', 'spread': '22.07', 'groupId': 'OG000'}, {'value': '23.40', 'spread': '27.35', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '21.53', 'spread': '12.00', 'groupId': 'OG000'}, {'value': '22.87', 'spread': '15.14', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '34.89', 'spread': '32.59', 'groupId': 'OG000'}, {'value': '30.73', 'spread': '26.54', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '98.30', 'spread': '35.22', 'groupId': 'OG000'}, {'value': '99.49', 'spread': '41.24', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '22.74', 'spread': '22.91', 'groupId': 'OG000'}, {'value': '23.21', 'spread': '28.38', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '21.62', 'spread': '12.35', 'groupId': 'OG000'}, {'value': '22.87', 'spread': '15.50', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '35.37', 'spread': '33.62', 'groupId': 'OG000'}, {'value': '28.73', 'spread': '19.92', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '99.18', 'spread': '34.95', 'groupId': 'OG000'}, {'value': '99.43', 'spread': '40.80', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '22.75', 'spread': '23.38', 'groupId': 'OG000'}, {'value': '23.01', 'spread': '28.87', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '21.60', 'spread': '12.55', 'groupId': 'OG000'}, {'value': '22.91', 'spread': '15.69', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '34.34', 'spread': '29.93', 'groupId': 'OG000'}, {'value': '28.43', 'spread': '20.15', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '100.8', 'spread': '36.04', 'groupId': 'OG000'}, {'value': '99.75', 'spread': '41.90', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '23.05', 'spread': '23.95', 'groupId': 'OG000'}, {'value': '23.43', 'spread': '29.67', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '21.88', 'spread': '12.84', 'groupId': 'OG000'}, {'value': '23.29', 'spread': '16.08', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '35.80', 'spread': '34.83', 'groupId': 'OG000'}, {'value': '28.34', 'spread': '20.35', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '99.80', 'spread': '34.22', 'groupId': 'OG000'}, {'value': '97.68', 'spread': '33.66', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '23.22', 'spread': '24.74', 'groupId': 'OG000'}, {'value': '23.55', 'spread': '30.34', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '21.63', 'spread': '12.98', 'groupId': 'OG000'}, {'value': '23.50', 'spread': '16.37', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '35.50', 'spread': '34.74', 'groupId': 'OG000'}, {'value': '27.76', 'spread': '19.77', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '97.33', 'spread': '35.95', 'groupId': 'OG000'}, {'value': '92.19', 'spread': '35.33', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '22.57', 'spread': '22.33', 'groupId': 'OG000'}, {'value': '25.65', 'spread': '39.19', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '21.43', 'spread': '12.21', 'groupId': 'OG000'}, {'value': '24.60', 'spread': '20.64', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '35.08', 'spread': '31.28', 'groupId': 'OG000'}, {'value': '30.01', 'spread': '22.38', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '97.46', 'spread': '35.63', 'groupId': 'OG000'}, {'value': '95.18', 'spread': '36.81', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '23.15', 'spread': '23.24', 'groupId': 'OG000'}, {'value': '27.80', 'spread': '42.76', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '21.55', 'spread': '12.72', 'groupId': 'OG000'}, {'value': '25.82', 'spread': '22.44', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '35.27', 'spread': '32.43', 'groupId': 'OG000'}, {'value': '31.39', 'spread': '23.44', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '86.87', 'spread': '30.05', 'groupId': 'OG000'}, {'value': '78.53', 'spread': '22.77', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '22.34', 'spread': '24.62', 'groupId': 'OG000'}, {'value': '27.50', 'spread': '50.75', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '20.93', 'spread': '12.70', 'groupId': 'OG000'}, {'value': '25.37', 'spread': '26.59', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '35.62', 'spread': '37.07', 'groupId': 'OG000'}, {'value': '30.47', 'spread': '21.40', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '87.33', 'spread': '30.52', 'groupId': 'OG000'}, {'value': '78.97', 'spread': '22.92', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '22.51', 'spread': '24.78', 'groupId': 'OG000'}, {'value': '27.82', 'spread': '51.41', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '20.80', 'spread': '12.29', 'groupId': 'OG000'}, {'value': '25.81', 'spread': '26.81', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '36.23', 'spread': '37.42', 'groupId': 'OG000'}, {'value': '30.46', 'spread': '21.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean Change From BL in Liver Function Parameters in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Alkaline Phosphatase Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-7.27', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-10.8', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '1.10', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-2.64', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '1.50', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-4.42', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '-2.83', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-13.3', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-18.8', 'spread': '2.85', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.39', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-1.69', 'spread': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '1.30', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-4.96', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '-3.98', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-10.0', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '2.74', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.81', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-6.81', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-4.51', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-12.4', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '3.02', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '1.43', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '-3.11', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-1.82', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-5.15', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '-3.66', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-14.6', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-14.7', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-5.63', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '-4.65', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-14.9', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '-10.6', 'spread': '3.19', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-2.35', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-5.74', 'spread': '4.66', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-3.00', 'spread': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-6.76', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '-3.09', 'spread': '2.91', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-12.4', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '3.80', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-1.41', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '-4.98', 'spread': '5.60', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.20', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-1.71', 'spread': '2.98', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-3.66', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '-4.00', 'spread': '2.95', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-10.6', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '-4.24', 'spread': '3.57', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '-8.08', 'spread': '7.91', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.95', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-2.37', 'spread': '4.26', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-10.2', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '-4.92', 'spread': '3.49', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-14.2', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '-7.76', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-2.56', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '-7.43', 'spread': '8.65', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '4.64', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-13.9', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '-4.51', 'spread': '2.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean BL Select Laboratory Parameters in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Total Bilirubin Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen (BUN) Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '16.05', 'spread': '5.19', 'groupId': 'OG000'}, {'value': '15.09', 'spread': '4.41', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '9.26', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '9.26', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '3.48', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '3.56', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '96.63', 'spread': '29.30', 'groupId': 'OG000'}, {'value': '98.78', 'spread': '58.76', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '4.80', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '4.83', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '16.02', 'spread': '5.23', 'groupId': 'OG000'}, {'value': '15.03', 'spread': '4.40', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '9.26', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '9.24', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '3.50', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '97.36', 'spread': '30.59', 'groupId': 'OG000'}, {'value': '98.56', 'spread': '60.79', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '4.79', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '4.75', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '96.49', 'spread': '29.70', 'groupId': 'OG000'}, {'value': '97.65', 'spread': '61.54', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '15.86', 'spread': '5.28', 'groupId': 'OG000'}, {'value': '15.02', 'spread': '4.36', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '9.26', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '9.25', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '3.49', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '95.81', 'spread': '28.90', 'groupId': 'OG000'}, {'value': '95.35', 'spread': '55.47', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '4.73', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '4.75', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '15.93', 'spread': '5.29', 'groupId': 'OG000'}, {'value': '14.88', 'spread': '3.96', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '9.25', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '9.25', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '3.49', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '96.81', 'spread': '30.21', 'groupId': 'OG000'}, {'value': '98.59', 'spread': '64.79', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '4.66', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '4.68', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '16.15', 'spread': '5.74', 'groupId': 'OG000'}, {'value': '14.77', 'spread': '3.78', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '9.30', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '9.30', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '3.50', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '3.44', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '96.82', 'spread': '31.18', 'groupId': 'OG000'}, {'value': '101.1', 'spread': '74.67', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '4.70', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '4.93', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '16.26', 'spread': '5.68', 'groupId': 'OG000'}, {'value': '15.18', 'spread': '3.88', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '9.31', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '9.33', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '3.51', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '98.59', 'spread': '33.41', 'groupId': 'OG000'}, {'value': '104.80', 'spread': '81.64', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '4.72', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '4.99', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '16.36', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '15.27', 'spread': '3.91', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '9.41', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '9.48', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '3.61', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '100.4', 'spread': '31.96', 'groupId': 'OG000'}, {'value': '111.1', 'spread': '97.97', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '4.58', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '16.40', 'spread': '5.86', 'groupId': 'OG000'}, {'value': '15.22', 'spread': '3.95', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '9.43', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '9.48', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '3.58', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '99.29', 'spread': '30.71', 'groupId': 'OG000'}, {'value': '111.4', 'spread': '99.31', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '4.61', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '1.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean Change From BL in Select Laboratory Parameters in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Total Bilirubin Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen (BUN) Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '16.05', 'spread': '5.19', 'groupId': 'OG000'}, {'value': '15.09', 'spread': '4.41', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-1.65', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-4.06', 'spread': '4.29', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-1.77', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-4.74', 'spread': '5.18', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-4.95', 'spread': '4.84', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '5.09', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '3.27', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '5.51', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '3.00', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '9.71', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-1.58', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '-2.70', 'spread': '11.88', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.100', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '-18.2', 'spread': '16.92', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'BUN Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Serum Calcium Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorous Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '6.85', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '-8.86', 'spread': '17.98', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean BL Serum Electrolytes in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Serum Sodium Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '139.9', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '140.7', 'spread': '3.03', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '4.27', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '104.1', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '105.0', 'spread': '3.63', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '139.8', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '140.7', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '4.27', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '103.9', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '104.9', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '139.9', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '140.7', 'spread': '3.11', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '4.27', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '104.0', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '104.9', 'spread': '3.64', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '139.9', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '140.7', 'spread': '3.16', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '4.27', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '104.0', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '105.0', 'spread': '3.64', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '140.0', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '140.7', 'spread': '3.11', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '4.26', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '4.28', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '104.1', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '104.8', 'spread': '3.60', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '139.6', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '140.5', 'spread': '3.56', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '4.25', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '4.25', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '103.9', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '104.9', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '139.5', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '140.1', 'spread': '3.72', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '4.27', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '4.24', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '103.8', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '104.8', 'spread': '4.33', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '138.2', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '139.0', 'spread': '3.91', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '4.31', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '102.3', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '103.0', 'spread': '4.23', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '138.2', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '138.9', 'spread': '3.93', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '4.30', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '4.28', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '102.3', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '102.9', 'spread': '4.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'PRIMARY', 'title': 'Mean Change From BL in Serum Electrolytes in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'Serum Sodium Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 365 (n=365, 157)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 729 (n=328, 143)', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,093 (n=312, 138)', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,457 (n=292, 130)', 'categories': [{'measurements': [{'value': '104.0', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '105.0', 'spread': '3.64', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,821 (n=262,124)', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,905 (n=134, 68)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 1,989 (n=121,56)', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 2,073 (n=81,38)', 'categories': [{'measurements': [{'value': '2.27', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '2.76', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride Day 2,185 (n=82,37)', 'categories': [{'measurements': [{'value': '2.95', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '1.81', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'BL (Day 0) IL-6 for Day 169 Cohort (n=357, 175)', 'categories': [{'measurements': [{'value': '36.35', 'spread': '43.53', 'groupId': 'OG000'}, {'value': '39.90', 'spread': '54.43', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) SIL-2R for Day 169 Cohort (n=370, 171)', 'categories': [{'measurements': [{'value': '1776', 'spread': '946.5', 'groupId': 'OG000'}, {'value': '1603', 'spread': '933.1', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) TNF-Alpha for D169 Cohort (n=354,172)', 'categories': [{'measurements': [{'value': '5.94', 'spread': '7.90', 'groupId': 'OG000'}, {'value': '7.86', 'spread': '29.41', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) IL-6 for Day 365 Cohort (n=247, 121)', 'categories': [{'measurements': [{'value': '35.27', 'spread': '49.06', 'groupId': 'OG000'}, {'value': '37.89', 'spread': '49.61', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) SIL-2R for Day 365 Cohort (n=235, 106)', 'categories': [{'measurements': [{'value': '1674', 'spread': '835.1', 'groupId': 'OG000'}, {'value': '1601', 'spread': '1076', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) TNF-Alpha for D365 Cohort (n=246, 119)', 'categories': [{'measurements': [{'value': '5.55', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '5.46', 'spread': '8.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'pg / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'IL-6 Day 169 (n=357, 175)', 'categories': [{'measurements': [{'value': '-21.0', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-5.81', 'spread': '3.00', 'groupId': 'OG001'}]}]}, {'title': 'SIL-2R Day 169 (n=370, 171)', 'categories': [{'measurements': [{'value': '-519.0', 'spread': '32.72', 'groupId': 'OG000'}, {'value': '-85.5', 'spread': '32.78', 'groupId': 'OG001'}]}]}, {'title': 'TNF-Alpha Day 169 (n=354, 172)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '2.49', 'groupId': 'OG001'}]}]}, {'title': 'IL-6 Day 365 (n=247, 121)', 'categories': [{'measurements': [{'value': '-23.4', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '-1.82', 'spread': '5.23', 'groupId': 'OG001'}]}]}, {'title': 'SIL-2R Day 365(n=235, 106)', 'categories': [{'measurements': [{'value': '-562', 'spread': '40.82', 'groupId': 'OG000'}, {'value': '-290', 'spread': '87.97', 'groupId': 'OG001'}]}]}, {'title': 'TNF-Alpha Day 365 (n=246, 119)', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '2.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.', 'unitOfMeasure': 'pg / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in RF in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'Placebo + MTX DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'BL (Day 0) for Day 169 Cohort (n=308, 126)', 'categories': [{'measurements': [{'value': '-49.8', 'spread': '10.90', 'groupId': 'OG000'}, {'value': '-18.6', 'spread': '10.28', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) for Day 365 Cohort (n=281, 104)', 'categories': [{'measurements': [{'value': '-46.5', 'spread': '11.44', 'groupId': 'OG000'}, {'value': '-5.83', 'spread': '22.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'IU / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'Placebo + MTX DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'BL (Day 0) E-Selectin for D169 Cohort (n= 256,126)', 'categories': [{'measurements': [{'value': '85.89', 'spread': '72.62', 'groupId': 'OG000'}, {'value': '85.53', 'spread': '68.42', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) SICAM-1 for D169 Cohort (n=264, 130)', 'categories': [{'measurements': [{'value': '444.0', 'spread': '398.1', 'groupId': 'OG000'}, {'value': '426.8', 'spread': '323.5', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) MMP3 for D169 Cohort (n=362, 183)', 'categories': [{'measurements': [{'value': '83.37', 'spread': '81.53', 'groupId': 'OG000'}, {'value': '77.22', 'spread': '73.72', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) E-Selectin fpr D365 Cohort (n=162, 74)', 'categories': [{'measurements': [{'value': '85.91', 'spread': '71.66', 'groupId': 'OG000'}, {'value': '88.39', 'spread': '75.09', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) SICAM-1 for D365 Cohort (n=235, 114)', 'categories': [{'measurements': [{'value': '467.2', 'spread': '578.5', 'groupId': 'OG000'}, {'value': '449.5', 'spread': '356.0', 'groupId': 'OG001'}]}]}, {'title': 'BL (Day 0) MMP3 for D365 Cohort (n=232, 112)', 'categories': [{'measurements': [{'value': '79.56', 'spread': '78.35', 'groupId': 'OG000'}, {'value': '64.02', 'spread': '59.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.', 'unitOfMeasure': 'ng / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'OG001', 'title': 'Placebo + MTX DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}], 'classes': [{'title': 'E-Selectin Day 169 (n= 256, 126)', 'categories': [{'measurements': [{'value': '-13.8', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '-6.52', 'spread': '4.44', 'groupId': 'OG001'}]}]}, {'title': 'SICAM-1 Day 169 (n=264, 130)', 'categories': [{'measurements': [{'value': '-65.0', 'spread': '9.87', 'groupId': 'OG000'}, {'value': '-42.0', 'spread': '17.02', 'groupId': 'OG001'}]}]}, {'title': 'MMP3 Day 169 (n=362, 183)', 'categories': [{'measurements': [{'value': '-37.2', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '-8.03', 'spread': '3.88', 'groupId': 'OG001'}]}]}, {'title': 'E-Selectin Day 365 (n=162, 74)', 'categories': [{'measurements': [{'value': '-15.4', 'spread': '4.37', 'groupId': 'OG000'}, {'value': '-9.94', 'spread': '5.73', 'groupId': 'OG001'}]}]}, {'title': 'SICAM-1 Day 365 (n=235, 114)', 'categories': [{'measurements': [{'value': '-80.0', 'spread': '27.20', 'groupId': 'OG000'}, {'value': '-43.7', 'spread': '16.25', 'groupId': 'OG001'}]}]}, {'title': 'MMP3 Day 365 (n=232, 112)', 'categories': [{'measurements': [{'value': '-41.0', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '-12.1', 'spread': '5.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.', 'unitOfMeasure': 'ng / mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=369, 160)', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=372, 160)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=372, 160)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=372, 160)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=372, 158)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=370, 160)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=370, 160)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=371, 160)', 'categories': [{'measurements': [{'value': '1.80', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=369, 160)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=369, 160)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=372, 160)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=372, 160)', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=372, 160)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=372, 158)', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=370, 160)', 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=370, 160)', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=371, 160)', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=369, 160)', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=366, 157)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=367, 157)', 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=367, 157)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=367, 157)', 'categories': [{'measurements': [{'value': '1.64', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=367, 155)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=367, 157)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n= 367, 157)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=368, 157)', 'categories': [{'measurements': [{'value': '1.81', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=367, 157)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 449', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=366, 157)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=367, 157)', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=367, 157)', 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=367, 157)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=367, 155)', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=367, 157)', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n= 367, 157)', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=368, 157)', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=367, 157)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 449', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=354, 157)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=355, 156)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=355, 157)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '.078', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=355, 156)', 'categories': [{'measurements': [{'value': '1.64', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=351, 156)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=354, 157)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=354, 157)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=354, 157)', 'categories': [{'measurements': [{'value': '1.81', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=354, 157)', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 533', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=354, 157)', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=355, 156)', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=355, 157)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=355, 156)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=351, 156)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=354, 157)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=354, 157)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=354, 157)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=354, 157)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 533', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=348, 154)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=348, 155)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=348, 155)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=348, 155)', 'categories': [{'measurements': [{'value': '1.64', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=348, 154)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=348, 155)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=348, 155)', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=348, 154)', 'categories': [{'measurements': [{'value': '1.82', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=348, 155)', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 617', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=348, 154)', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=348, 155)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=348, 155)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=348, 155)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=348, 154)', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=348, 155)', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=348, 155)', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=348, 154)', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=348, 155)', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 617', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=337, 148)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=337, 148)', 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=338, 148)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n= 337, 148)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=338, 147)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=338, 148)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=336, 148)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=338, 148)', 'categories': [{'measurements': [{'value': '1.81', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=338, 148)', 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 729', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=337, 148)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=337, 148)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=338, 148)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n= 337, 148)', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=338, 147)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=338, 148)', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=336, 148)', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=338, 148)', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=338, 148)', 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 729', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=325, 146)', 'categories': [{'measurements': [{'value': '1.70', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=325, 147)', 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=325, 147)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=325, 147)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=324, 146)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=325, 146)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=324, 146)', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=325, 146)', 'categories': [{'measurements': [{'value': '1.81', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=324, 146)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 813', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=325, 146)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=325, 147)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=325, 147)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=325, 147)', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=324, 146)', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=325, 146)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=324, 146)', 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=325, 146)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=324, 146)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 813', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=318, 140)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=319, 140)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=319, 140)', 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=319, 140)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=319, 138)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=319, 140)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=319, 140)', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '2.01', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=319, 140)', 'categories': [{'measurements': [{'value': '1.80', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=319, 140)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 897', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=318, 140)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=319, 140)', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=319, 140)', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=319, 140)', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=319, 138)', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=319, 140)', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=319, 140)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=319, 140)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=319, 140)', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 897', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=312, 137)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=312, 137)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=312, 137)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=312, 137)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=308, 136)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=312, 137)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=312, 137)', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=312, 137)', 'categories': [{'measurements': [{'value': '1.80', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=312, 137)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 981', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=312, 137)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=312, 137)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=312, 137)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=312, 137)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=308, 136)', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=312, 137)', 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=312, 137)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=312, 137)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=312, 137)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 981', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=308, 137)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=310, 138)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=309, 138)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=309, 138)', 'categories': [{'measurements': [{'value': '1.62', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=308, 137)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=310, 137)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=310, 137)', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=310, 137)', 'categories': [{'measurements': [{'value': '1.79', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=310, 137)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,093', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=308, 137)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=310, 138)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=309, 138)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=309, 138)', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=308, 137)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=310, 137)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=310, 137)', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=310, 137)', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=310, 137)', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,093', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=274, 125)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=274, 125)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=274, 125)', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=274, 125)', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=272, 122)', 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=275, 124)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=275, 125)', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=275, 125)', 'categories': [{'measurements': [{'value': '1.83', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=275, 125)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,177', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=274, 125)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=274, 125)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=274, 125)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=274, 125)', 'categories': [{'measurements': [{'value': '-0.92', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=272, 122)', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=275, 124)', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=275, 125)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=275, 125)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=275, 125)', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,177', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=292, 134)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=292, 135)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=292, 135)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=292, 135)', 'categories': [{'measurements': [{'value': '1.64', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=290, 134)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=292, 134)', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=292, 134)', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=292, 134)', 'categories': [{'measurements': [{'value': '1.79', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=292, 133)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,261', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=292, 134)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=292, 135)', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=292, 135)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=292, 135)', 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=290, 134)', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=292, 134)', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=292, 134)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=292, 134)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=292, 133)', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,261', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=152, 62)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=152, 62)', 'categories': [{'measurements': [{'value': '1.45', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=152, 62)', 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=152, 62)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=151, 62)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=152, 62)', 'categories': [{'measurements': [{'value': '1.82', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=152, 62)', 'categories': [{'measurements': [{'value': '1.98', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=152, 62)', 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=152, 62)', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,345', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=152, 62)', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=152, 62)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=152, 62)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=152, 62)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=151, 62)', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=152, 62)', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=152, 62)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=152, 62)', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=152, 62)', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,345', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=289, 129)', 'categories': [{'measurements': [{'value': '1.70', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=289, 129)', 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=289, 129)', 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=289, 129)', 'categories': [{'measurements': [{'value': '1.64', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=287, 126)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=289, 129)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=289, 129)', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=289, 129)', 'categories': [{'measurements': [{'value': '1.80', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=289, 129)', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,457', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=289, 129)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=289, 129)', 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=289, 129)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=289, 129)', 'categories': [{'measurements': [{'value': '-0.89', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=287, 126)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=289, 129)', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=289, 129)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=289, 129)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=289, 129)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,457', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=280, 126)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=280, 126)', 'categories': [{'measurements': [{'value': '1.46', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=280, 126)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=280, 126)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=279, 125)', 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=280, 126)', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=280, 126)', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=280, 126)', 'categories': [{'measurements': [{'value': '1.80', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=280, 126)', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,625', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=280, 126)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=280, 126)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=280, 126)', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=280, 126)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=279, 125)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=280, 126)', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=280, 126)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=280, 126)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=280, 126)', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,625', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=273, 125)', 'categories': [{'measurements': [{'value': '1.69', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=273, 125)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=273, 125)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=273, 124)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=271, 122)', 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=273, 125)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=273, 125)', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=273, 125)', 'categories': [{'measurements': [{'value': '1.79', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=273, 125)', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,821', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=273, 125)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=273, 125)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=273, 125)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=273, 124)', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=271, 122)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=273, 125)', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=273, 125)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=273, 125)', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=273, 125)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,821', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=119, 55)', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=119, 55)', 'categories': [{'measurements': [{'value': '1.51', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=119, 55)', 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=119, 55)', 'categories': [{'measurements': [{'value': '1.66', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=117, 54)', 'categories': [{'measurements': [{'value': '1.45', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=119, 55)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=119, 55)', 'categories': [{'measurements': [{'value': '2.08', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=119, 55)', 'categories': [{'measurements': [{'value': '1.85', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=119, 55)', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,989', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=119, 55)', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=119, 55)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=119, 55)', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=119, 55)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=117, 54)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=119, 55)', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=119, 55)', 'categories': [{'measurements': [{'value': '-0.89', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=119, 55)', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=119, 55)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 1,989', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=85, 38)', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=85, 37)', 'categories': [{'measurements': [{'value': '1.54', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=85, 38)', 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=85, 38)', 'categories': [{'measurements': [{'value': '1.64', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=84, 38)', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=85, 38)', 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=85, 38)', 'categories': [{'measurements': [{'value': '2.11', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=85, 38)', 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=85, 38)', 'categories': [{'measurements': [{'value': '2.04', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 2,185', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}, {'id': 'OG001', 'title': 'MTX + Placebo DB', 'description': 'Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'classes': [{'title': 'HAQ DI (n=85, 38)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Dressing and Grooming (n=85, 37)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Arising (n=85, 38)', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Eating (n=85, 38)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Walking (n=84, 38)', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Hygiene (n=85, 38)', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Reaching (n=85, 38)', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Gripping (n=85, 38)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Activities (n=85, 38)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Day 0), Day 2,185', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abatacept (ABA) + Methotrexate (MTX) DB', 'description': 'Abatacept was dosed intravenously by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of \\< 10 mg/wk were acceptable if due to toxicity.'}, {'id': 'FG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}, {'id': 'FG002', 'title': 'ABA + MTX [Open-label (OL)]', 'description': 'Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.'}], 'periods': [{'title': 'Double-Blind Period Days 1 to 169', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '433'}, {'groupId': 'FG001', 'numSubjects': '219'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unknown Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-Blind Period Days 170 to 365', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Poor/Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'No Longer Met Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '539'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '379'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '160'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'No Longer Met Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Administrative Decision By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Unknown Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Participants in this evaluation were enrolled 116 sites worldwide: 31 sites in the United States; 32 sites in Europe, 13 sites in Canada; 4 sites in Australia; 7 sites in Argentina; 7 sites in Brazil; 7 sites in Mexico; 3 sites in Peru; 5 sites in South Africa; 3 sites in Taiwan; and 4 sites in Turkey.', 'preAssignmentDetails': 'Of 1250 participants enrolled, 594 participants were not randomized (519 no longer met study criteria, 37 for unknown reasons, 33 withdrew consent, 3 lost to follow-up, 1 administrative reason by sponsor, and 1 adverse event). Four participants (2 per group) were randomized but never treated; 2 no longer met study criteria and 2 withdrew consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '652', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ABA + MTX DB', 'description': 'Abatacept was dosed by weight with participants weighing \\< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \\> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}, {'id': 'BG001', 'title': 'MTX + Placebo DB', 'description': 'Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of \\< 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '516', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '379', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '572', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Rheumatoid Arthritis (RA) Disease', 'classes': [{'title': '<= 2 years', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}, {'title': '> 2 years to <= 5 years', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': '> 5 years to <=10 years', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': '> 10 years', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with RA duration \\<= 2 years, \\> 2 years to \\<= 5 years, \\> 5 years to \\<= 10 years, and \\> 10 years as evaluated at baseline.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-26', 'studyFirstSubmitDate': '2002-11-02', 'resultsFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2002-11-12', 'lastUpdatePostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-26', 'studyFirstPostDateStruct': {'date': '2002-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169', 'timeFrame': 'Day 169', 'description': 'ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.'}, {'measure': 'Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365', 'timeFrame': 'Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value'}, {'measure': 'Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.'}, {'measure': 'Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'Marked abnormality criteria are: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.'}, {'measure': 'Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'Marked abnormality criteria are: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.'}, {'measure': 'Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'Sodium \\< 0.9 \\* LLN or \\> 1.05 \\* ULN or if BL \\< LLN then use \\< 0.95 \\* BL or \\> ULN or if BL \\> ULN then use \\>1.05 \\*BL or \\< LLN; Potassium: \\< 0.9 \\* LLN or \\> 1.1 \\* ULN or if BL \\< LLN then use \\< 0.9 \\* BL or \\> ULN or if BL \\> ULN then use 1.1 \\* BL or \\< LLN; Chloride: \\< 0.9 \\* LLN or \\> 1.1 \\* ULN or if BL \\< LLN then use \\<0.9 \\* BL or \\>ULN or if BL \\> ULN then use \\> 1.1 \\* BL or \\< LLN; Calcium \\<0.8 \\* LLN or \\> 1.2 \\* ULN or if BL \\< LLN then use \\<0.67 \\* BL or \\> ULN or if BL \\> ULN then use \\> 1.3 \\* BL or \\< LLN.'}, {'measure': 'Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'Glucose: \\< 65 mg/dL or \\> 220 mg/dL; Fasting Glucose: \\<0.8 \\* LLN or \\> 1.5 \\* ULN or if BL \\< LLN then use \\< 0.8 \\* BL or \\> ULN or if BL \\> ULN then use 1.1 \\* BL or \\< LLN; Total protein: \\< 0.9 \\* LLN or 1.1 \\* ULN or if BL \\< LLN then use 0.9 \\* BL or \\> ULN or if BL \\> ULN then use 1.1 \\* BL or \\< LLN; Albumin: \\< 0.9 \\* LLN or if BL \\< LLN then use 0.75 \\* BL; Uric acid: \\> 1.5 \\* ULN or if BL \\> ULN then use \\> 2.0 \\* BL. All urinalysis abnormalities were defined as: if missing BL then use \\>= 2 or if value \\>=4, or if BL = 0 or 0.5 then use \\>= 2, or if BL = 1.0 then use \\>= 3, or if BL = 2.0 then use \\>=4.'}, {'measure': 'Mean BL Immunoglobulins Over Time in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.'}, {'measure': 'Mean Change From BL in Immunoglobulins in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093'}, {'measure': 'Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period', 'timeFrame': 'Day 1 to Day 1,821', 'description': 'Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.'}, {'measure': 'Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period', 'timeFrame': 'Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.', 'description': 'Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.'}, {'measure': 'Number of Participants Experiencing AEs of Special Interest in the OL Period', 'timeFrame': 'Day 365 to Day 2,185', 'description': 'AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.'}, {'measure': 'Mean BL Hematocrit in the OL Period', 'timeFrame': 'Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.'}, {'measure': 'Mean Change From BL in Participant Hematocrit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.'}, {'measure': 'Mean BL Platelet Count in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.'}, {'measure': 'Mean Change From BL in Participant Platelet Count in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.'}, {'measure': 'Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.'}, {'measure': 'Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.'}, {'measure': 'Mean BL White Blood Cells in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.'}, {'measure': 'Mean Change From BL in White Blood Cells in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.'}, {'measure': 'Mean BL Liver Function Parameters in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.'}, {'measure': 'Mean Change From BL in Liver Function Parameters in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.'}, {'measure': 'Mean BL Select Laboratory Parameters in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.'}, {'measure': 'Mean Change From BL in Select Laboratory Parameters in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.'}, {'measure': 'Mean BL Serum Electrolytes in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.'}, {'measure': 'Mean Change From BL in Serum Electrolytes in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185', 'description': 'All changes in participant laboratory parameters were monitored on each day of study drug administration.'}], 'secondaryOutcomes': [{'measure': 'Mean Number of Tender Joints and Swollen Joints at DB BL', 'timeFrame': 'BL (Day 0)'}, {'measure': 'Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment', 'timeFrame': 'BL (Day 0)', 'description': 'Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.'}, {'measure': 'BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 365)', 'description': 'This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was \\> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.'}, {'measure': 'ACR 20 Responders at Day 365', 'timeFrame': 'Day 365', 'description': 'ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.'}, {'measure': 'ACR 20 Responders in the Double-Blind (DB) Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.'}, {'measure': 'ACR 50 Responders at Day 169', 'timeFrame': 'Day 169', 'description': 'ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.'}, {'measure': 'ACR 50 Responders at Day 365', 'timeFrame': 'Day 365', 'description': 'ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.'}, {'measure': 'ACR 50 Responders in the DB Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.'}, {'measure': 'ACR 70 Responders at Day 169', 'timeFrame': 'Day 169', 'description': 'ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.'}, {'measure': 'ACR 70 Responders at Day 365', 'timeFrame': 'Day 365', 'description': 'ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.'}, {'measure': 'ACR 70 Responders in the DB Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.'}, {'measure': 'Number of Participants Achieving Major Clinical Response By Day 365', 'timeFrame': 'Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.', 'description': 'A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.'}, {'measure': 'Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365', 'timeFrame': 'BL (Day 0), Day 169, Day 365, Day 169, Day 365', 'description': 'The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\\>5.1); low (≤3.2); remission (\\<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period', 'timeFrame': 'Day 1 to Day 365', 'description': 'AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.'}, {'measure': 'Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.'}, {'measure': 'Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Participants in the DB Period Achieving an Extended Major Clinical Response', 'timeFrame': 'Day 1 to Day 365', 'description': 'An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.'}, {'measure': 'Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.'}, {'measure': 'Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.'}, {'measure': 'Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.'}, {'measure': 'ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.'}, {'measure': 'ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.'}, {'measure': 'ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.'}, {'measure': 'ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365', 'description': 'CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.'}, {'measure': 'Number of Participants Discontinuing in the DB Period', 'timeFrame': 'Day 1 to Day 169, Day 170 to Day 365', 'description': 'Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.'}, {'measure': 'Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.'}, {'measure': 'Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period', 'timeFrame': 'Day 1 to Day 365', 'description': 'All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.'}, {'measure': 'Participants Experiencing AEs of Special Interest in the DB Period', 'timeFrame': 'Day 1 to Day 365', 'description': 'AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.'}, {'measure': 'Mean BL Individual Components of the HAQ DI at Day 169 and Day 365', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169', 'timeFrame': 'Day 169', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365', 'timeFrame': 'Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Number of Participants With Immunogenicity to Abatacept in the DB Period', 'timeFrame': 'Day 1 to Day 365', 'description': 'Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.'}, {'measure': 'Number of New Tender Joints and Number of New Swollen Joints in the DB Period', 'timeFrame': 'Day 169, Day 365', 'description': 'Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.'}, {'measure': 'Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period', 'timeFrame': 'Day 169, Day 365'}, {'measure': 'Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period', 'timeFrame': 'Day 1 to Day 365', 'description': 'Marked abnormality criteria were: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.'}, {'measure': 'Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period', 'timeFrame': 'Day 1 to Day 365', 'description': 'Marked abnormality criteria were: Aspartate Aminotransferase (AST) \\>3 \\* ULN or if BL \\> ULN then use \\>4 \\*BL; Alanine Aminotransferase (ALT) \\>3 \\* ULN or if BL \\> ULN then use \\> 4 \\* BL; Creatinine \\> 1.5 \\* BL.'}, {'measure': 'Mean BL ESR and CRP Levels in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185', 'description': 'Mean baseline values are reported for each cohort at each time point.'}, {'measure': 'Mean Change From BL in ESR in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185', 'description': 'Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.'}, {'measure': 'Participant RF Seroconversion in the OL Period', 'timeFrame': 'Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185', 'description': 'This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was \\> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.'}, {'measure': 'Number of ACR 20 Responders in the DB and OL Periods', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821', 'description': 'ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.'}, {'measure': 'Number of ACR 50 Responders in the DB and OL Periods', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821', 'description': 'ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.'}, {'measure': 'Number of ACR 70 Responders in the DB and OL Periods', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821', 'description': 'ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.'}, {'measure': 'Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\\> 5.1); low (≤ 3.2); remission (\\< 2.6).'}, {'measure': 'Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period', 'timeFrame': 'BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period', 'timeFrame': 'BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Change from baseline in participant were calculated at all study visits in the DB and OL periods.'}, {'measure': 'Mean BL DAS-28 ESR Over Time in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL in DAS-28 ESR Over Time in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.'}, {'measure': 'Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period', 'timeFrame': 'Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821', 'description': 'Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL Physical Function Component of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL General Health Component of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL Vitality Component of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL Mental Health Component of the SF-36 by Visit in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \\> 3 points were considered clinically meaningful.'}, {'measure': 'Mean BL Fatigue in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL in Fatigue in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.'}, {'measure': 'Mean BL Sleep Quality in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep \\[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.'}, {'measure': 'Mean Change From BL in Sleep Quality in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185', 'description': 'The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep \\[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.'}, {'measure': 'Mean BL Limitations on Activities of Daily Living in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457', 'description': 'Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL in Limitations on Activities of Daily Living in the OL Period', 'timeFrame': 'BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457', 'description': 'The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.'}, {'measure': 'Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.'}, {'measure': 'Mean Change From BL in RF in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.'}, {'measure': 'Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period', 'timeFrame': 'BL (Day 0), Day 169, Day 365', 'description': 'The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 365', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 449', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 449', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 533', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 533', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 617', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 617', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 729', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 729', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 813', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 813', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 897', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 897', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 981', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 981', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,093', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,093', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,177', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,177', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,261', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,261', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,345', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,345', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,457', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,457', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,625', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,625', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,821', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,821', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,989', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 1,989', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 2,185', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}, {'measure': 'Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period', 'timeFrame': 'BL (Day 0), Day 2,185', 'description': 'The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '16785475', 'type': 'RESULT', 'citation': 'Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Ge Z, Becker JC, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006 Jun 20;144(12):865-76. doi: 10.7326/0003-4819-144-12-200606200-00003.'}, {'pmid': '24786925', 'type': 'DERIVED', 'citation': 'Kremer JM, Peterfy C, Russell AS, Emery P, Abud-Mendoza C, Sibilia J, Becker JC, Westhovens R, Genant HK. Longterm safety, efficacy, and inhibition of structural damage progression over 5 years of treatment with abatacept in patients with rheumatoid arthritis in the abatacept in inadequate responders to methotrexate trial. J Rheumatol. 2014 Jun;41(6):1077-87. doi: 10.3899/jrheum.130263. Epub 2014 May 1.'}, {'pmid': '18383390', 'type': 'DERIVED', 'citation': 'Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Teng J, Becker JC, Westhovens R. Results of a two-year followup study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum. 2008 Apr;58(4):953-63. doi: 10.1002/art.23397.'}]}, 'descriptionModule': {'briefSummary': 'Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.\n\nLong Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis of RA.\n* Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.'}, 'identificationModule': {'nctId': 'NCT00048568', 'briefTitle': 'A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate', 'orgStudyIdInfo': {'id': 'IM101-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abatacept + Methotrexate', 'description': 'Short Term: Abatacept was dosed by weight with participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. Participants continued treatment with methotrexate (MTX) either orally or parenterally at a minimum dose of 15 mg.', 'interventionNames': ['Drug: Abatacept', 'Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Methotrexate', 'description': 'Short Term: Participants received a placebo solution intravenously and methotrexate at the dose employed prior to study enrollment and a minimum of 15 mg.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Abatacept + Methotrexate Open Label', 'description': 'Open Label: Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \\< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \\> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.', 'interventionNames': ['Drug: Abatacept', 'Drug: Methotrexate']}], 'interventions': [{'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['BMS-188667'], 'description': 'Intravenous (IV) Solution, - Weight Titered (500 mg \\< 60 kg); (750 mg 60-100 kg), )1 gram \\> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year', 'armGroupLabels': ['Abatacept + Methotrexate', 'Abatacept + Methotrexate Open Label']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['MTX'], 'description': 'Tablets, Oral, \\>= 15 mg, weekly, 1 year', 'armGroupLabels': ['Abatacept + Methotrexate', 'Abatacept + Methotrexate Open Label', 'Placebo + Methotrexate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year', 'armGroupLabels': ['Placebo + Methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Corona', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}, {'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Hamden', 'state': 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