Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00195702
Status:
COMPLETED
Last Update Posted:
2011-08-26
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With 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': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)', 'description': 'The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.', 'eventGroups': [{'id': 'EG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.', 'otherNumAtRisk': 212, 'otherNumAffected': 167, 'seriousNumAtRisk': 212, 'seriousNumAffected': 34}, {'id': 'EG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.', 'otherNumAtRisk': 207, 'otherNumAffected': 148, 'seriousNumAtRisk': 207, 'seriousNumAffected': 27}, {'id': 'EG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.', 'otherNumAtRisk': 200, 'otherNumAffected': 149, 'seriousNumAtRisk': 200, 'seriousNumAffected': 20}, {'id': 'EG003', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).', 'otherNumAtRisk': 553, 'otherNumAffected': 511, 'seriousNumAtRisk': 553, 'seriousNumAffected': 271}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 120}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 103}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 106}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 72}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 97}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 63}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 79}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 95}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 116}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 74}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 94}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 77}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 76}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 83}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 42}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 51}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 225}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 118}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 119}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 150}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 123}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1 and 13.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 39}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 59}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 31}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 33}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 50}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 46}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pelvic prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pulmonary toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoaesthesia facial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ankle operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Breast prosthesis implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Breast reconstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Finger amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Foot operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastric bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mastectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Spinal laminectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 553, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': "The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Modified Total Sharp X-ray Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '4.9', 'groupId': 'OG000', 'lowerLimit': '-14.5', 'upperLimit': '50.5'}, {'value': '0.1', 'spread': '4.8', 'groupId': 'OG001', 'lowerLimit': '-37.0', 'upperLimit': '23.5'}, {'value': '2.7', 'spread': '6.8', 'groupId': 'OG002', 'lowerLimit': '-25.0', 'upperLimit': '39.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.', 'groupDescription': 'The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.', 'groupDescription': 'The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \\[normal\\] to 398 \\[maximal disease\\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 24 or early termination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting ACR20 Response Criteria at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Total Sharp X-ray Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \\[normal\\] to 398 \\[maximal disease\\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 52.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.52', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. LOCF data analysis was used for missing values.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.56', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.', 'groupDescription': 'The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.', 'groupDescription': 'The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Last observation carried forward (LOCF) data analysis was used for missing values.'}, {'type': 'SECONDARY', 'title': 'Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'title': 'Maintained Response', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': 'Did Not Maintain Response', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a \\>= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were responders at Week 12 or 24 were evaluated to determine whether the response was maintained. LOCF data analysis was used for missing values.'}, {'type': 'SECONDARY', 'title': 'Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'title': 'Maintained Response', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Did Not Maintain Response', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were ACR20 responders at Week 24 were evaluated to determine whether the response was maintained. Observed data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 52', 'description': 'Patients were responders if they had: \\>= 70% improvement in tender joint count; \\>= 70% improvement in swollen joint count; and \\>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'title': 'Non-responder', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 52', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR20 response criteria for the first time at each time point is presented.'}, {'type': 'SECONDARY', 'title': 'Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'title': 'Non-responder', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 52', 'description': 'Patients were responders if they had: \\>= 50% improvement in tender joint count; \\>= 50% improvement in swollen joint count; and \\>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR50 response criteria for the first time at each time point is presented.'}, {'type': 'SECONDARY', 'title': 'Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'title': 'Non-responder', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 52', 'description': 'Patients were responders if they had: \\>= 70% improvement in tender joint count; \\>= 70% improvement in swollen joint count; and \\>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR70 response criteria for the first time at each time point is presented.'}, {'type': 'SECONDARY', 'title': 'Estimated Yearly Progression of Rheumatoid Arthritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'OG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}], 'classes': [{'title': 'Estimated yearly progression', 'categories': [{'measurements': [{'value': '11.11', 'spread': '16.75', 'groupId': 'OG000'}, {'value': '9.46', 'spread': '10.42', 'groupId': 'OG001'}, {'value': '9.97', 'spread': '12.84', 'groupId': 'OG002'}]}]}, {'title': 'Actual progression during study', 'categories': [{'measurements': [{'value': '0.77', 'spread': '4.90', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '4.75', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '6.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '553', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '413', 'groupId': 'OG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group', 'description': 'Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '553', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'title': '< 40 years', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Between 40 and 64 years', 'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}]}]}, {'title': 'Between 65 and 74 years', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group', 'description': 'Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 260', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed as observed (without imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 520', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (without imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 260', 'description': 'Patients were responders if they had: \\>= 50% improvement in tender joint count; \\>= 50% improvement in swollen joint count; and \\>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 520', 'description': 'Patients were responders if they had: \\>= 50% improvement in tender joint count; \\>= 50% improvement in swollen joint count; and \\>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 260', 'description': 'Patients were responders if they had: \\>= 70% improvement in tender joint count; \\>= 70% improvement in swollen joint count; and \\>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 520', 'description': 'Patients were responders if they had: \\>= 70% improvement in tender joint count; \\>= 70% improvement in swollen joint count; and \\>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 520', 'description': 'Patients were responders if they had: \\>=70% improvement in tender joint count; \\>=70% improvement in swollen joint count; and \\>=70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing response. Analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 260', 'description': "The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 520', 'description': "The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 260', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab Through Year 10', 'description': 'Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 520', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Modified Total Sharp X-ray Score at Week 416', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).'}, {'id': 'OG002', 'title': 'DB Placebo ew/OL Adalimumab 40 mg Eow', 'description': 'Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.16', 'spread': '7.969', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '9.310', 'groupId': 'OG001'}, {'value': '4.83', 'spread': '10.012', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 416', 'description': 'Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \\[normal\\] to 398 \\[maximal disease\\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Modified Total Sharp X-ray Score at Week 520', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).'}, {'id': 'OG001', 'title': 'DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).'}, {'id': 'OG002', 'title': 'DB Placebo ew/OL Adalimumab 40 mg Eow', 'description': 'Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.60', 'spread': '8.822', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '10.430', 'groupId': 'OG001'}, {'value': '6.18', 'spread': '12.071', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 520', 'description': 'Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \\[normal\\] to 398 \\[maximal disease\\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'FG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'FG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'FG003', 'title': 'DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 20 mg weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.'}, {'id': 'FG004', 'title': 'DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.'}, {'id': 'FG005', 'title': 'DB Placebo ew/OL Adalimumab 40 mg Eow', 'description': 'Subjects received placebo weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.'}], 'periods': [{'title': 'Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'For all groups, started indicates when the subjects entered the 52-week double-blind phase.', 'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '200'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '159'}, {'groupId': 'FG002', 'numSubjects': '140'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Open-label Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': '3 subjects completed the double-blind phase but did not enter the open-label extension phase.', 'groupId': 'FG003', 'numSubjects': '165'}, {'comment': '1 subject completed the double-blind phase but did not enter the open-label extension phase.', 'groupId': 'FG004', 'numSubjects': '158'}, {'comment': '6 subjects completed the double-blind phase but did not enter the open-label extension phase.', 'groupId': 'FG005', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '66'}, {'groupId': 'FG004', 'numSubjects': '80'}, {'groupId': 'FG005', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '99'}, {'groupId': 'FG004', 'numSubjects': '78'}, {'groupId': 'FG005', 'numSubjects': '78'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at 95 sites in the United States and Canada between February 2000 and August 2001.', 'preAssignmentDetails': 'Eligible subjects who were taking disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) entered a 4- to 6-week washout period, during which previous DMARDs (except MTX) were discontinued. Subjects who were not taking DMARDs, other than MTX, entered directly into the 52-week double-blind treatment period of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}, {'value': '619', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DB Adalimumab 20 mg ew', 'description': 'Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.'}, {'id': 'BG001', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'BG002', 'title': 'DB Placebo ew', 'description': 'Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 40 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'Between 40 and 64 years', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '402', 'groupId': 'BG003'}]}]}, {'title': 'Between 65 and 74 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '464', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 619}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-23', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-02', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)', 'timeFrame': 'Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group', 'description': 'Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.'}, {'measure': 'Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)', 'timeFrame': 'Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group', 'description': 'Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.'}, {'measure': 'Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260', 'timeFrame': 'Week 260', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.'}, {'measure': 'Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520', 'timeFrame': 'Week 520', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.'}, {'measure': 'Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260', 'timeFrame': 'Week 260', 'description': 'Patients were responders if they had: \\>= 50% improvement in tender joint count; \\>= 50% improvement in swollen joint count; and \\>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.'}, {'measure': 'Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520', 'timeFrame': 'Week 520', 'description': 'Patients were responders if they had: \\>= 50% improvement in tender joint count; \\>= 50% improvement in swollen joint count; and \\>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.'}, {'measure': 'Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260', 'timeFrame': 'Week 260', 'description': 'Patients were responders if they had: \\>= 70% improvement in tender joint count; \\>= 70% improvement in swollen joint count; and \\>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.'}, {'measure': 'Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520', 'timeFrame': 'Week 520', 'description': 'Patients were responders if they had: \\>= 70% improvement in tender joint count; \\>= 70% improvement in swollen joint count; and \\>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.'}, {'measure': 'Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10', 'timeFrame': 'Baseline through Week 520', 'description': 'Patients were responders if they had: \\>=70% improvement in tender joint count; \\>=70% improvement in swollen joint count; and \\>=70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein.'}, {'measure': 'Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260', 'timeFrame': 'Week 260', 'description': "The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change."}, {'measure': 'Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520', 'timeFrame': 'Week 520', 'description': "The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change."}, {'measure': 'Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260', 'timeFrame': 'Baseline and Week 260', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.'}, {'measure': 'Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520', 'timeFrame': 'Baseline and Week 520', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.'}, {'measure': 'Change From Baseline in Modified Total Sharp X-ray Score at Week 416', 'timeFrame': 'Baseline and Week 416', 'description': 'Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \\[normal\\] to 398 \\[maximal disease\\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.'}, {'measure': 'Change From Baseline in Modified Total Sharp X-ray Score at Week 520', 'timeFrame': 'Baseline and Week 520', 'description': 'Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \\[normal\\] to 398 \\[maximal disease\\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.'}], 'primaryOutcomes': [{'measure': 'Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24', 'timeFrame': 'Week 24', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.'}, {'measure': 'Change From Baseline in Modified Total Sharp X-ray Score at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \\[normal\\] to 398 \\[maximal disease\\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.'}, {'measure': 'Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Meeting ACR20 Response Criteria at Week 52', 'timeFrame': 'Week 52', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.'}, {'measure': 'Change From Baseline in Modified Total Sharp X-ray Score at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \\[normal\\] to 398 \\[maximal disease\\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.'}, {'measure': 'Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.'}, {'measure': 'Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24', 'timeFrame': 'Week 52', 'description': 'Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a \\>= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.'}, {'measure': 'Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24', 'timeFrame': 'Week 52', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.'}, {'measure': 'Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment', 'timeFrame': 'Baseline through Week 52', 'description': 'Patients were responders if they had: \\>= 70% improvement in tender joint count; \\>= 70% improvement in swollen joint count; and \\>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.'}, {'measure': 'Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point', 'timeFrame': 'Baseline through Week 52', 'description': 'Patients were responders if they had: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.'}, {'measure': 'Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point', 'timeFrame': 'Baseline through Week 52', 'description': 'Patients were responders if they had: \\>= 50% improvement in tender joint count; \\>= 50% improvement in swollen joint count; and \\>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.'}, {'measure': 'Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point', 'timeFrame': 'Baseline through Week 52', 'description': 'Patients were responders if they had: \\>= 70% improvement in tender joint count; \\>= 70% improvement in swollen joint count; and \\>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.'}, {'measure': 'Estimated Yearly Progression of Rheumatoid Arthritis', 'timeFrame': 'Baseline and Week 52', 'description': 'Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31707982', 'type': 'DERIVED', 'citation': 'Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL. Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials. Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.'}, {'pmid': '29018564', 'type': 'DERIVED', 'citation': 'Keystone EC, Breedveld FC, van der Heijde D, van Vollenhoven RF, Emery P, Smolen JS, Sainsbury I, Florentinus S, Kupper H, Chen K, Kavanaugh A. Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. eCollection 2017.'}, {'pmid': '27338778', 'type': 'DERIVED', 'citation': 'Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.'}, {'pmid': '25139667', 'type': 'DERIVED', 'citation': 'Emery P, Kavanaugh A, Bao Y, Ganguli A, Mulani P. Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis? Ann Rheum Dis. 2015 Dec;74(12):2165-74. doi: 10.1136/annrheumdis-2014-205302. Epub 2014 Aug 19.'}, {'pmid': '25073879', 'type': 'DERIVED', 'citation': 'Landewe R, Ostergaard M, Keystone EC, Florentinus S, Liu S, van der Heijde D. Analysis of integrated radiographic data from two long-term, open-label extension studies of adalimumab for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):180-6. doi: 10.1002/acr.22426.'}, {'pmid': '23818718', 'type': 'DERIVED', 'citation': 'Keystone EC, van der Heijde D, Kavanaugh A, Kupper H, Liu S, Guerette B, Mozaffarian N. Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10-year data in longstanding rheumatoid arthritis. J Rheumatol. 2013 Sep;40(9):1487-97. doi: 10.3899/jrheum.120964. Epub 2013 Jul 1.'}, {'pmid': '21285171', 'type': 'DERIVED', 'citation': 'Keystone EC, Kavanaugh A, Weinblatt ME, Patra K, Pangan AL. Clinical consequences of delayed addition of adalimumab to methotrexate therapy over 5 years in patients with rheumatoid arthritis. J Rheumatol. 2011 May;38(5):855-62. doi: 10.3899/jrheum.100752. Epub 2011 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.', 'detailedDescription': 'This was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. Data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through Week 52 and for all patients who received at least one dose of adalimumab during the 10-year study (the Intent-to-Treat \\[ITT\\] population).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older and in good health (Investigator discretion) with a recent stable medical history\n* Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid arthritis (RA) and had at both screening and baseline visits \\>=6 swollen joints and \\>=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints \\[DIPs\\] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs \\[DMARDs\\] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.)\n* Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX intolerant).\n* If patient on a second-line treatment (DMARD) other than MTX, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period).\n* Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week.\n* Both rheumatoid factor positivity and a C-reactive protein value \\>=1 mg/dL, or at least one joint erosion on X-ray.\n\nExclusion Criteria:\n\n* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.\n* Female subject who was pregnant or breast-feeding or considering becoming pregnant.\n* Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab.\n* Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.\n* Intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit.\n* Subject was wheelchair bound or bedridden.'}, 'identificationModule': {'nctId': 'NCT00195702', 'briefTitle': 'Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate', 'orgStudyIdInfo': {'id': 'DE019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DB adalimumab 20 mg ew', 'description': 'Subjects received 20 mg adalimumab subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.', 'interventionNames': ['Biological: Adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'DB adalimumab 40 mg eow', 'description': 'Subjects received 40 mg adalimumab subcutaneously (SC) every other week (eow) and concomitant methotrexate (MTX) during the double-blind (DB) phase. Subjects received placebo injections SC and concomitant MTX on the alternate weeks during the DB phase.', 'interventionNames': ['Biological: Adalimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DB placebo ew', 'description': 'Subjects received placebo subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DB adalimumab 20 mg ew/OL adalimumab 40 mg eow', 'description': 'Subjects received adalimumab 20 mg subcutaneously (SC) once weekly (ew) during the double-blind (DB) phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).', 'interventionNames': ['Biological: Adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'DB adalimumab 40 mg eow/OL adalimumab 40 mg eow', 'description': 'Subjects received adalimumab 40 mg subcutaneously (SC) every other week (eow) with placebo on alternate weeks during the double-blind (DB) phase, then adalimumab 40 mg SC eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).', 'interventionNames': ['Biological: Adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'DB placebo ew/OL adalimumab 40 mg eow', 'description': 'Subjects received placebo subcutaneously (SC) once weekly (ew) during the double-blind phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).', 'interventionNames': ['Biological: Adalimumab']}], 'interventions': [{'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-D2E7', 'Humira'], 'description': 'Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.', 'armGroupLabels': ['DB adalimumab 20 mg ew']}, {'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-D2E7', 'Humira'], 'description': 'Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.', 'armGroupLabels': ['DB adalimumab 40 mg eow']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.', 'armGroupLabels': ['DB placebo ew']}, {'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-D2E7', 'Humira'], 'description': 'Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.', 'armGroupLabels': ['DB adalimumab 20 mg ew/OL adalimumab 40 mg eow']}, {'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-D2E7', 'Humira'], 'description': 'Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.', 'armGroupLabels': ['DB adalimumab 40 mg eow/OL adalimumab 40 mg eow']}, {'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-D2E7', 'Humira'], 'description': 'Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.', 'armGroupLabels': ['DB placebo ew/OL adalimumab 40 mg eow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site Ref # / Investigator 424', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2510', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site Ref # / Investigator 60729', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site Ref # / Investigator 725', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Site Ref # / Investigator 60736', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Site Ref # / Investigator 360', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92037-0943', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Site Ref # / Investigator 714', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Site Ref # / Investigator 469', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92260', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Site Ref # / Investigator 419', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '95126', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Site Ref # / Investigator 492', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '93405', 'city': 'San Louis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'Site Ref # / Investigator 60734'}, {'zip': '91405', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'facility': 'Site Ref # / Investigator 60739', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Site Ref # / Investigator 712', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Ref # / Investigator 710', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '34698', 'city': 'Dunedin', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Ref # / Investigator 498', 'geoPoint': {'lat': 28.0199, 'lon': -82.77323}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Ref # / Investigator 499', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Ref # / Investigator 729', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33542', 'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Ref # / Investigator 463', 'geoPoint': {'lat': 28.23362, 'lon': -82.18119}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2436', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Site Ref # / Investigator 485', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site Ref # / Investigator 60732', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site Ref # / Investigator 726', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2506', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Site Ref # / Investigator 732', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '66216', 'city': 'Shawnee Mission', 'state': 'Kansas', 'country': 'United States', 'facility': 'Site Ref # / Investigator 60730', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'zip': '67203', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Site Ref # / Investigator 467', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Site Ref # / Investigator 494', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Site Ref # / Investigator 491', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2508', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '21239', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site Ref # / Investigator 392', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21502', 'city': 'Cumberland', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site Ref # / Investigator 354', 'geoPoint': {'lat': 39.65287, 'lon': -78.76252}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site Ref # / Investigator 730', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site Ref # / Investigator 465', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '01610', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site Ref # / Investigator 2512', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '49506', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site Ref # / Investigator 471', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site Ref # / Investigator 473', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Site Ref # 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