Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-04-10 @ 7:19 PM
Study NCT ID:
NCT00989235
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2009-10-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Abatacept 5mg/kg (ST)', 'otherNumAtRisk': 50, 'otherNumAffected': 17, 'seriousNumAtRisk': 50, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Abatacept 10mg/kg (ST)', 'otherNumAtRisk': 58, 'otherNumAffected': 18, 'seriousNumAtRisk': 58, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Abatacept 10mg/kg (Open-Label)', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Xerophtalmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hiatus Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fibrocystic Breast Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiopulmonary Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diabetes Mellitus Inadequate Control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acquired Claw Toe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Disease Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 12 Months of treatment', 'description': 'Disease relapse is defined as additional DMARD therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 CRP score \\>= 3.2 at 2 consecutive visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed=number randomized.'}, {'type': 'SECONDARY', 'title': 'Mean Time-Matched Baseline DAS28 CRP Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Day 29 Cohort (n=45, 40)', 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 Cohort (n=47, 37)', 'categories': [{'measurements': [{'value': '2.06', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 Cohort (n=46, 42)', 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.09', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 Cohort (n=49, 39)', 'categories': [{'measurements': [{'value': '2.06', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '2.09', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 Cohort (n=47, 40)', 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 Cohort (n=46, 36)', 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 197 Cohort (n=44, 38)', 'categories': [{'measurements': [{'value': '2.08', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 Cohort (n=44, 38)', 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Day 253 Cohort (n=46, 37)', 'categories': [{'measurements': [{'value': '2.07', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 Cohort (n=45, 38)', 'categories': [{'measurements': [{'value': '2.07', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 309 Cohort (n=45, 37)', 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 337 Cohort (n=44, 36)', 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 Cohort (n=41, 35)', 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\\>5.1=high disease activity; \\<3.2=low disease activity; \\<2.6=remission).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed=number of participants randomized; n=All treated participants with available DAS28 CRP scores at that time point. Mean time-matched baseline values reflect changing n-values over time.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Day 29 (n=45, 40)', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n=47, 37)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n=46, 42)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (n=49, 39)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (n=47, 40)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n=46, 36)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 197 (n=44, 38)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (n=44, 38)', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 253 (n=46, 37)', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 281 (n=45, 38)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Day 309 (n=45, 37)', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Day 337 (n=44, 36)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=41, 35)', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.46', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.17', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 57', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.20', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 85', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.04', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 113', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.32', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 141', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.15', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 169', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.13', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 197', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.25', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 225', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.36', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 253', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.38', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 281', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.22', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 309', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.31', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 337', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.55', 'estimateComment': 'Change from Baseline = Post-baseline - Baseline value.', 'groupDescription': 'Day 365', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365', 'description': 'Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\\>5.1=high disease activity; \\<3.2=low disease activity; \\<2.6=remission).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed=number of participants randomized; n=the number of participants with available DAS28 CRP scores at that time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '33.1'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '33.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-17.2', 'ciUpperLimit': '18.0', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For 95% CI: normal approximation with continuity correction.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'After 12 months of treatment', 'description': 'DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\\>5.1=high disease activity; \\<3.2=low disease activity; \\<2.6=remission).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed= number of participants randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '8.1'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '21.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.6', 'ciLowerLimit': '-20.3', 'ciUpperLimit': '3.2', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For 95% CI: normal approximation with continuity correction.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'After 12 months of treatment', 'description': 'Additional DMARD therapy is defined as a re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed= number of participants randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 12 months of treatment', 'description': 'A course of high dose steroids is defined as a course of intramuscular, intravenous, or high dose oral corticosteroids (use of \\> 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed= number of participants randomized.'}, {'type': 'PRIMARY', 'title': 'Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Month 1 (n=55, 49)', 'categories': [{'measurements': [{'value': '5.17', 'groupId': 'OG000'}, {'value': '2.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=52, 47)', 'categories': [{'measurements': [{'value': '8.65', 'groupId': 'OG000'}, {'value': '4.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=51, 42)', 'categories': [{'measurements': [{'value': '10.41', 'groupId': 'OG000'}, {'value': '12.35', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=50, 38)', 'categories': [{'measurements': [{'value': '12.17', 'groupId': 'OG000'}, {'value': '22.78', 'groupId': 'OG001'}]}]}, {'title': 'Month 5 (n=47, 35)', 'categories': [{'measurements': [{'value': '13.96', 'groupId': 'OG000'}, {'value': '26.96', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=42, 33)', 'categories': [{'measurements': [{'value': '23.11', 'groupId': 'OG000'}, {'value': '31.13', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=41, 32)', 'categories': [{'measurements': [{'value': '24.94', 'groupId': 'OG000'}, {'value': '33.22', 'groupId': 'OG001'}]}]}, {'title': 'Month 8 (n=40, 31)', 'categories': [{'measurements': [{'value': '26.77', 'groupId': 'OG000'}, {'value': '33.22', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=38, 31)', 'categories': [{'measurements': [{'value': '30.43', 'groupId': 'OG000'}, {'value': '33.22', 'groupId': 'OG001'}]}]}, {'title': 'Month 10 (n=37, 31)', 'categories': [{'measurements': [{'value': '32.27', 'groupId': 'OG000'}, {'value': '33.22', 'groupId': 'OG001'}]}]}, {'title': 'Month 11 (n=37, 30)', 'categories': [{'measurements': [{'value': '32.27', 'groupId': 'OG000'}, {'value': '35.37', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=36, 28)', 'categories': [{'measurements': [{'value': '32.27', 'groupId': 'OG000'}, {'value': '35.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.870', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.69', 'estimateComment': 'Hazard ratio determined by a Cox proportional hazards model with treatment as the only covariate.', 'groupDescription': 'Through Month 12', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12', 'description': 'An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score \\>=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse).', 'unitOfMeasure': 'Percentage of Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed=number of participants randomized. n=number of participants at risk at the end of a specified month.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '13.4'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '15.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-12.9', 'ciUpperLimit': '10.7', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For 95% CI: normal approximation with continuity correction.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'After 12 months of treatment', 'description': 'All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg or 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed= number of participants randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Modified Therapy During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '18.2'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '28.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-22.6', 'ciUpperLimit': '7.3', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '95% CI: normal approximation with continuity correction.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'After 12 months of treatment', 'description': 'Modified therapy=additional DMARD therapy, 2 or more courses of high dose steroids or rescue medication. Additional DMARD therapy=re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. A course of high dose steroids=a course of intramuscular, intravenous, or high dose oral corticosteroids (use of \\> 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). Rescue medication=abatacept 10 mg/kg.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed= number of participants randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Lost Remission Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000', 'lowerLimit': '40.6', 'upperLimit': '66.3'}, {'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '50.7', 'upperLimit': '77.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'estimate of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.6', 'ciLowerLimit': '-31.1', 'ciUpperLimit': '10.0', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '95% CI: normal approximation with continuity correction.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'After 12 months of treatment', 'description': 'Loss of remission is defined as DAS 28 CRP \\>=2.6.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed= number of participants randomized.'}, {'type': 'SECONDARY', 'title': 'Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Main Study Day 701 (n=41, 36)', 'categories': [{'measurements': [{'value': '22992.0', 'spread': '9722.1', 'groupId': 'OG000'}, {'value': '21713.5', 'spread': '9520.5', 'groupId': 'OG001'}]}]}, {'title': 'Sub-Study Day 1 (n=46, 41)', 'categories': [{'measurements': [{'value': '22213.0', 'spread': '9275.8', 'groupId': 'OG000'}, {'value': '23620.7', 'spread': '9648.0', 'groupId': 'OG001'}]}]}, {'title': 'Sub-Study Day 85 (n=47, 43)', 'categories': [{'measurements': [{'value': '24919.5', 'spread': '14516.2', 'groupId': 'OG000'}, {'value': '11922.1', 'spread': '5681.8', 'groupId': 'OG001'}]}]}, {'title': 'Sub-Study Day 169 (n=48, 43)', 'categories': [{'measurements': [{'value': '25725.7', 'spread': '18500.5', 'groupId': 'OG000'}, {'value': '9959.2', 'spread': '5045.0', 'groupId': 'OG001'}]}]}, {'title': 'Sub-Study Day 253 (n=47, 42)', 'categories': [{'measurements': [{'value': '28524.7', 'spread': '19989.9', 'groupId': 'OG000'}, {'value': '13516.2', 'spread': '6564.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 701 of the main study; sub-study Days 1, 85, 169, 253', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed= number of participants randomized; n =randomized participants with measurement at given time point. For the Day 701 measure, one apparent outlier sample was deleted..'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed = All treated participants during the double-blind period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Total Participants with Infection and Infestation', 'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000'}, {'value': '26.0', 'groupId': 'OG001'}]}]}, {'title': 'Upper Respiratory Tract Infection', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'Nasopharyngitis', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Influenza', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Tract Infection', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Onychomycosis', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngitis', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Rhinitis', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Ear Infection', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal Infection', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Appendicitis', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Furuncle', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis Bacterial', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Endocarditis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Fungal Skin Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Herpes Simplex', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Labyrinthitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Oral Herpes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Tract Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Infection and Infestation AEs = any AE within the System Organ Class Infection and Infestation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed = All treated participants during the double-blind period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 5 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'All neoplasms were assessed by medical review as to whether or not the event was malignant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed = All treated participants during the double-blind period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Total Participants with AIAEs (mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Total Participants with AIAEs (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Participants with AIAEs (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Participants with AIAEs (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorders - Hypertension (mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorders - Hypertension (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorders - Hypertension (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorders - Hypertension (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorders - Hypertension (unknown)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Acute Infusional AE= a subset of the peri-infusional AEs with onset during the first hour after the start of the study drug infusion. A total of 105 infusional events were prespecified in the protocol.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed = All treated participants during the double-blind period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Total Participants with PIAEs (mild)', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Total Participants with PIAEs (moderate)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Participants with PIAEs (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Participants with PIAEs (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorders, Nausea (mild)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorders, Nausea (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorders, Nausea (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorders, Nausea (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorders, Vomiting (mild)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorders, Vomiting (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorders, Vomiting (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorders, Vomiting (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorders, Dizziness (mild)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorders, Dizziness (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorders, Dizziness (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorders, Dizziness (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorders, Headache (mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorders, Headache (moderate)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorders, Headache (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorders, Headache (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC, Malaise (mild)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC, Malaise (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC, Malaise (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC, Malaise (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC, Chest Pain (mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC, Chest Pain (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC, Chest Pain (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC, Chest Pain (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RTMD, Asthma (mild)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RTMD, Asthma (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RTMD, Asthma (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RTMD, Asthma (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RTMD, Cough (mild)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RTMD, Cough (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RTMD, Cough (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RTMD, Cough (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorders, Hypertension (mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorders, Hypertension (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorders, Hypertension (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorders, Hypertension (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Peri-infusional AE=a pre-specified infusional AE occuring during the first 24 hours after the start of study drug infusion.A total of 105 infusional events were prespecified in the protocol. GDASC=General Disorders and Administration Site Conditions, RTMD=Respiratory, Thoracic and Mediastinal Disorders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed = All treated participants during the double-blind period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Total Participants with ADs (mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Total Participants with ADs (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Participants with ADs (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Participants with ADs (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eye Disorders - Episcleritis (mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Eye Disorders - Episcleritis (moderate)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eye Disorders - Episcleritis (severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eye Disorders - Episcleritis (very severe)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': "MCTDs - Sjogren's Syndrome (mild)", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': "MCTDs - Sjogren's Syndrome (moderate)", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': "MCTDs - Sjogren's Syndrome (severe)", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': "MCTDs - Sjogren's Syndrome (very severe)", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed = All treated participants during the double-blind period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'Hemoglobin, Low: >3 g/dL ↓ from pre rx (n=51, 48)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit, Low: <0.75 x pre rx (n=51, 48)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythrocytes, Low: <0.75 x pre rx (n=51, 48)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALP, High: >2 x upper limit normal (ULN)(n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Calcium, Low: <0.8 x Lower LN(LLN)(n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelet Count, Low: <0.67 x LLN (n=51, 48)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelet Count, High: >1.5 x ULN (n=51, 48)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes, Low: <0.75 x LLN (n=51, 48)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'N+B (absolute), Low: < 1.00 x 10^3 c/uL (n=55, 49)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (absolute), Low (*) (n=55, 49)', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (absolute), High (*) (n=55, 49)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes (absolute), High: >2000/mm^3 (n=55, 49)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Basophils (absolute), High: > 400/mm^3 (n=55, 49)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils (absolute), High (*) (n=55, 49)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'AST, High: >3 x ULN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT, High: >3 x ULN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GGT, High: >2 x ULN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Total, High: >1.5 x ULN (n=52, 46)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen, High: >2 x pre rx (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium, Low: <0.95 x LLN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium, High: >1.05 x ULN, (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium, Low: <0.9 x LLN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium, High: >1.1 x ULN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride, Low: <0.9 x LLN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride, High: >1.1 x ULN, (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Calcium, High: >1.2 x ULN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorus, Low: <0.75 x LLN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic Phosphorus, High: >1.25 x ULN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose, Low: <65 mg/dL (n=55, 48)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose, High: >220 mg/dL (n=55, 48)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein, Low: <0.9 x LLN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein, High: >1.1 x ULN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, Low: <0.9 x LLN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid, High: >1.5 x ULN (n=52, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein, High: >=2-4 (n=55, 47)', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Urine Glucose, High: >=2-4 (n=55, 47)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Blood, High: >=2-4 (n=55, 47)', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Urine Leukocyte Esterase, High: >=2-4 (n=20, 16)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Urine White Blood Cells, High: >=2-4 (n=22, 14)', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Urine Red Blood Cells, High: >=2-4 (n=22, 14)', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'Not evaluated: high hemoglobin,high hematocrit,high erythrocytes,high neutrophils+bands(N+B),low monocytes,low basophils,low eosinophils,low alkaline phosphatase(ALP),low aspartate aminotransferase(AST),low alanine aminotransferase(ALT),low G-Glutamyl transferase(GGT),low total bilirubin,low blood urea nitrogen,low creatinine,high albumin,low uric acid,low urine protein,low urine glucose,low urine blood,low urine leukocyte esterase,low urine white blood cells,low red blood cells.Pre Rx=pretreatment,(\\*)Lymphocytes(c/uL):Low\\<.750x10\\^3,High\\>7.50x10\\^3.(\\*)Eosinophils:\\>.750x10\\^3 c/uL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed = All treated participants during the double-blind period; n=number of participants with specific measure'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Vital Signs and Physical Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 5 mg/kg'}], 'paramType': 'NUMBER', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done because clinically significant changes in vital signs and physical findings were reported as adverse events.'}, {'type': 'SECONDARY', 'title': 'Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 10 mg/kg'}, {'id': 'OG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study treated with double-blind abatacept 5 mg/kg'}], 'classes': [{'title': 'CTLA4 and Possibly IG', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'IG and/or Junction Region', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 12 months of treatment', 'description': "A positive antibody response to Abatacept (measured by the ECL assay) is further classified as a positive response for either Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig)' or 'Ig and/or Junction Region'", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed= Number of participants with available immunogenicity measurements'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All subjects in the sub-study randomized to receive double-blind abatacept 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.'}, {'id': 'FG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'Number Rescued to Open-Label Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'comment': 'Of these, 1 was discontinued from open-label treatment (lost to follow-up).', 'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Number Completing Double-Blind Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Desire to Become Pregnant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized by Mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'IM101023 (NCT00122382) was a 2-year study completing on Day 729, in which subjects were randomized to receive abatacept or placebo in combination with methotrexate (MTX) for the 1st year of the study and were then switched to open-label abatacept+MTX in the 2nd year. All subjects had received abatacept for a least 1 year prior start of sub-study.', 'preAssignmentDetails': 'Of the 433 participants who completed the main study (IM101-023 NCT00122382), 108 enrolled in the sub-study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg'}, {'id': 'BG001', 'title': 'Abatacept (5 mg/kg)', 'description': 'All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '50.6', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '72.9', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '73.8', 'spread': '16.0', 'groupId': 'BG001'}, {'value': '73.4', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'One participant in the 10 mg/kg group did not have weight reported.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Activity Scores Using C-reactive Protein (DAS 28 [CRP])', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\\>5.1=high disease activity; \\<3.2=low disease activity; \\<2.6=remission).DAS 28 is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28 joints, C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm based on the following formula:\n\nDAS 28 = 0.56\\*sqrt(TJC28) + 0.28\\*sqrt(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*GH + 0.96.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-18', 'studyFirstSubmitDate': '2009-10-02', 'resultsFirstSubmitDate': '2011-05-12', 'studyFirstSubmitQcDate': '2009-10-02', 'lastUpdatePostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-12', 'studyFirstPostDateStruct': {'date': '2009-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12', 'description': 'An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score \\>=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Disease Relapse', 'timeFrame': 'After 12 Months of treatment', 'description': 'Disease relapse is defined as additional DMARD therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 CRP score \\>= 3.2 at 2 consecutive visits.'}, {'measure': 'Mean Time-Matched Baseline DAS28 CRP Scores', 'timeFrame': 'Baseline', 'description': 'Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\\>5.1=high disease activity; \\<3.2=low disease activity; \\<2.6=remission).'}, {'measure': 'Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment', 'timeFrame': 'Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365', 'description': 'Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\\>5.1=high disease activity; \\<3.2=low disease activity; \\<2.6=remission).'}, {'measure': 'Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)', 'timeFrame': 'After 12 months of treatment', 'description': 'DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\\>5.1=high disease activity; \\<3.2=low disease activity; \\<2.6=remission).'}, {'measure': 'Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment', 'timeFrame': 'After 12 months of treatment', 'description': 'Additional DMARD therapy is defined as a re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD.'}, {'measure': 'Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids', 'timeFrame': 'After 12 months of treatment', 'description': 'A course of high dose steroids is defined as a course of intramuscular, intravenous, or high dose oral corticosteroids (use of \\> 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals).'}, {'measure': 'Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment', 'timeFrame': 'After 12 months of treatment', 'description': 'All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg or 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg.'}, {'measure': 'Percentage of Participants Who Modified Therapy During Double-Blind Treatment', 'timeFrame': 'After 12 months of treatment', 'description': 'Modified therapy=additional DMARD therapy, 2 or more courses of high dose steroids or rescue medication. Additional DMARD therapy=re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. A course of high dose steroids=a course of intramuscular, intravenous, or high dose oral corticosteroids (use of \\> 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). Rescue medication=abatacept 10 mg/kg.'}, {'measure': 'Percentage of Participants Who Lost Remission Status', 'timeFrame': 'After 12 months of treatment', 'description': 'Loss of remission is defined as DAS 28 CRP \\>=2.6.'}, {'measure': 'Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment', 'timeFrame': 'Day 701 of the main study; sub-study Days 1, 85, 169, 253'}, {'measure': 'Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.'}, {'measure': 'Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Infection and Infestation AEs = any AE within the System Organ Class Infection and Infestation.'}, {'measure': 'Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'All neoplasms were assessed by medical review as to whether or not the event was malignant.'}, {'measure': 'Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Acute Infusional AE= a subset of the peri-infusional AEs with onset during the first hour after the start of the study drug infusion. A total of 105 infusional events were prespecified in the protocol.'}, {'measure': 'Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Peri-infusional AE=a pre-specified infusional AE occuring during the first 24 hours after the start of study drug infusion.A total of 105 infusional events were prespecified in the protocol. GDASC=General Disorders and Administration Site Conditions, RTMD=Respiratory, Thoracic and Mediastinal Disorders.'}, {'measure': 'Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders'}, {'measure': 'Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'Not evaluated: high hemoglobin,high hematocrit,high erythrocytes,high neutrophils+bands(N+B),low monocytes,low basophils,low eosinophils,low alkaline phosphatase(ALP),low aspartate aminotransferase(AST),low alanine aminotransferase(ALT),low G-Glutamyl transferase(GGT),low total bilirubin,low blood urea nitrogen,low creatinine,high albumin,low uric acid,low urine protein,low urine glucose,low urine blood,low urine leukocyte esterase,low urine white blood cells,low red blood cells.Pre Rx=pretreatment,(\\*)Lymphocytes(c/uL):Low\\<.750x10\\^3,High\\>7.50x10\\^3.(\\*)Eosinophils:\\>.750x10\\^3 c/uL.'}, {'measure': 'Clinically Significant Changes in Vital Signs and Physical Findings', 'timeFrame': 'From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)', 'description': 'Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature.'}, {'measure': 'Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment', 'timeFrame': 'After 12 months of treatment', 'description': "A positive antibody response to Abatacept (measured by the ECL assay) is further classified as a positive response for either Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig)' or 'Ig and/or Junction Region'"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NOS'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '25550337', 'type': 'DERIVED', 'citation': 'Westhovens R, Robles M, Ximenes AC, Wollenhaupt J, Durez P, Gomez-Reino J, Grassi W, Haraoui B, Shergy W, Park SH, Genant H, Peterfy C, Becker JC, Murthy B. Maintenance of remission following 2 years of standard treatment then dose reduction with abatacept in patients with early rheumatoid arthritis and poor prognosis. Ann Rheum Dis. 2015 Mar;74(3):564-8. doi: 10.1136/annrheumdis-2014-206149. Epub 2014 Dec 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 \\[DAS 28\\]-erythrocyte sedimentation rate \\[ESR\\] \\< 2.6) at Day 701 of study IM101023.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have completed the main study, are willing to participate and have a DAS 28 ESR score of \\< 2.6 on Day 701 of the main study\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00989235', 'briefTitle': 'Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study', 'orgStudyIdInfo': {'id': 'IM101-023 LT (Sub study)'}, 'secondaryIdInfos': [{'id': 'Eudrac # 2002-000784-26'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Abatacept (10 mg/Kg)', 'interventionNames': ['Drug: Abatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abatacept (5 mg/Kg)', 'interventionNames': ['Drug: Abatacept']}], 'interventions': [{'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['BMS-188667'], 'description': 'IV solution, IV, 10 mg/Kg, Once monthly, 1 year', 'armGroupLabels': ['Abatacept (10 mg/Kg)']}, {'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['BMS-188667'], 'description': 'IV solution, IV, 5 mg/Kg, Once monthly, 1 year', 'armGroupLabels': ['Abatacept (5 mg/Kg)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}