Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-26 @ 4:58 PM
Study NCT ID:
NCT01373151
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2011-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Peru']}, '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': 'C000604955', 'term': 'clazakizumab'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cslbehring.com', 'phone': '610-878-4000', 'title': 'Study Director', 'organization': 'CSL Behring'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 weeks per participant', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 24, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 43, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 43, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 51, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 43, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 50, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 35, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ejection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site macule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiraory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gamma-glutamyltransferease increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 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'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '76.3', 'groupId': 'OG001'}, {'value': '55.0', 'groupId': 'OG002'}, {'value': '73.3', 'groupId': 'OG003'}, {'value': '61.0', 'groupId': 'OG004'}, {'value': '60.0', 'groupId': 'OG005'}, {'value': '76.3', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 Weeks', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With ACR 20 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '81.4', 'groupId': 'OG001'}, {'value': '58.3', 'groupId': 'OG002'}, {'value': '65.0', 'groupId': 'OG003'}, {'value': '57.6', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}, {'value': '66.1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving ACR 50 Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '49.2', 'groupId': 'OG001'}, {'value': '26.7', 'groupId': 'OG002'}, {'value': '43.3', 'groupId': 'OG003'}, {'value': '28.8', 'groupId': 'OG004'}, {'value': '26.7', 'groupId': 'OG005'}, {'value': '30.5', 'groupId': 'OG006'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '47.5', 'groupId': 'OG001'}, {'value': '36.7', 'groupId': 'OG002'}, {'value': '46.7', 'groupId': 'OG003'}, {'value': '33.9', 'groupId': 'OG004'}, {'value': '43.3', 'groupId': 'OG005'}, {'value': '47.5', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 12 and 24', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving ACR 70 Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}, {'value': '13.3', 'groupId': 'OG002'}, {'value': '26.7', 'groupId': 'OG003'}, {'value': '11.9', 'groupId': 'OG004'}, {'value': '13.3', 'groupId': 'OG005'}, {'value': '11.9', 'groupId': 'OG006'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '27.1', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}, {'value': '25.4', 'groupId': 'OG004'}, {'value': '30.0', 'groupId': 'OG005'}, {'value': '18.6', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 12 and 24', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '54', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.1652', 'groupId': 'OG000'}, {'value': '-2.65', 'spread': '0.1610', 'groupId': 'OG001'}, {'value': '-2.29', 'spread': '0.1603', 'groupId': 'OG002'}, {'value': '-2.68', 'spread': '0.1597', 'groupId': 'OG003'}, {'value': '-2.34', 'spread': '0.1665', 'groupId': 'OG004'}, {'value': '-2.52', 'spread': '0.1610', 'groupId': 'OG005'}, {'value': '-2.04', 'spread': '0.1647', 'groupId': 'OG006'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-1.69', 'spread': '0.1825', 'groupId': 'OG000'}, {'value': '-3.01', 'spread': '0.1684', 'groupId': 'OG001'}, {'value': '-2.60', 'spread': '0.1719', 'groupId': 'OG002'}, {'value': '-3.06', 'spread': '0.1713', 'groupId': 'OG003'}, {'value': '-2.55', 'spread': '0.1769', 'groupId': 'OG004'}, {'value': '-2.95', 'spread': '0.1706', 'groupId': 'OG005'}, {'value': '-2.52', 'spread': '0.1769', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants (participants with missing values at each timepoint were not included)'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Remission by DAS28-CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'week 12', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '35.6', 'groupId': 'OG001'}, {'value': '21.7', 'groupId': 'OG002'}, {'value': '35.0', 'groupId': 'OG003'}, {'value': '25.4', 'groupId': 'OG004'}, {'value': '26.7', 'groupId': 'OG005'}, {'value': '20.3', 'groupId': 'OG006'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '49.2', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}, {'value': '35.6', 'groupId': 'OG004'}, {'value': '41.7', 'groupId': 'OG005'}, {'value': '23.7', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 12 and 24', 'description': 'DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Clinical Disease Activity Index (CDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-14.5', 'spread': '1.727', 'groupId': 'OG000'}, {'value': '-22.7', 'spread': '1.686', 'groupId': 'OG001'}, {'value': '-17.7', 'spread': '1.687', 'groupId': 'OG002'}, {'value': '-23.1', 'spread': '1.701', 'groupId': 'OG003'}, {'value': '-19.8', 'spread': '1.738', 'groupId': 'OG004'}, {'value': '-21.0', 'spread': '1.697', 'groupId': 'OG005'}, {'value': '-22.4', 'spread': '1.702', 'groupId': 'OG006'}]}]}, {'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-20.3', 'spread': '1.703', 'groupId': 'OG000'}, {'value': '-26.1', 'spread': '1.587', 'groupId': 'OG001'}, {'value': '-22.0', 'spread': '1.613', 'groupId': 'OG002'}, {'value': '-26.9', 'spread': '1.622', 'groupId': 'OG003'}, {'value': '-21.7', 'spread': '1.643', 'groupId': 'OG004'}, {'value': '-25.6', 'spread': '1.606', 'groupId': 'OG005'}, {'value': '-26.2', 'spread': '1.631', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.\n\nCDAI \\<= 2.8 = Remission CDAI \\> 2.8 and \\<= 10 = Low Disease Activity CDAI \\> 10 and \\<= 22 = Moderate Disease Activity CDAI \\> 22 = High Disease Activity', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants (participants with missing values at each timepoint were not included)'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Remission by CDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'week 12', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '8.3', 'groupId': 'OG003'}, {'value': '3.4', 'groupId': 'OG004'}, {'value': '3.3', 'groupId': 'OG005'}, {'value': '8.5', 'groupId': 'OG006'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}, {'value': '6.7', 'groupId': 'OG002'}, {'value': '21.7', 'groupId': 'OG003'}, {'value': '6.8', 'groupId': 'OG004'}, {'value': '20.0', 'groupId': 'OG005'}, {'value': '8.5', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 12 and 24', 'description': 'CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.\n\nCDAI \\<= 2.8 = Remission CDAI \\> 2.8 and \\<= 10 = Low Disease Activity CDAI \\> 10 and \\<= 22 = Moderate Disease Activity CDAI \\> 22 = High Disease Activity', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Simplified Disease Activity Index (SDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '54', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-14.5', 'spread': '1.794', 'groupId': 'OG000'}, {'value': '-24.9', 'spread': '1.749', 'groupId': 'OG001'}, {'value': '-20.4', 'spread': '1.745', 'groupId': 'OG002'}, {'value': '-25.3', 'spread': '1.734', 'groupId': 'OG003'}, {'value': '-22.2', 'spread': '1.811', 'groupId': 'OG004'}, {'value': '-23.3', 'spread': '1.747', 'groupId': 'OG005'}, {'value': '-23.2', 'spread': '1.785', 'groupId': 'OG006'}]}]}, {'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-20.6', 'spread': '1.812', 'groupId': 'OG000'}, {'value': '-28.4', 'spread': '1.670', 'groupId': 'OG001'}, {'value': '-24.5', 'spread': '1.704', 'groupId': 'OG002'}, {'value': '-29.1', 'spread': '1.698', 'groupId': 'OG003'}, {'value': '-23.5', 'spread': '1.755', 'groupId': 'OG004'}, {'value': '-27.6', 'spread': '1.691', 'groupId': 'OG005'}, {'value': '-27.6', 'spread': '1.752', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.\n\n0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects (participants with missing values at each timepoint were not included)'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Remission by SDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'week 12', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '8.3', 'groupId': 'OG003'}, {'value': '6.8', 'groupId': 'OG004'}, {'value': '5.0', 'groupId': 'OG005'}, {'value': '10.2', 'groupId': 'OG006'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}, {'value': '6.7', 'groupId': 'OG002'}, {'value': '20.', 'groupId': 'OG003'}, {'value': '6.8', 'groupId': 'OG004'}, {'value': '23.3', 'groupId': 'OG005'}, {'value': '8.5', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 12 and 24', 'description': 'SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.\n\n0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Remission Rate by Boolean Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'week 12', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}, {'value': '6.7', 'groupId': 'OG002'}, {'value': '10.', 'groupId': 'OG003'}, {'value': '1.7', 'groupId': 'OG004'}, {'value': '5.0', 'groupId': 'OG005'}, {'value': '5.1', 'groupId': 'OG006'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}, {'value': '5.0', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}, {'value': '5.1', 'groupId': 'OG004'}, {'value': '18.3', 'groupId': 'OG005'}, {'value': '10.2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 12 and 24', 'description': 'Boolean-based definition:\n\nAt any time point, a patient must satisfy all of the following:\n\nTJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'spread': '0.0827', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.0801', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '0.0807', 'groupId': 'OG002'}, {'value': '-0.70', 'spread': '0.0811', 'groupId': 'OG003'}, {'value': '-0.51', 'spread': '0.0834', 'groupId': 'OG004'}, {'value': '-0.60', 'spread': '0.0807', 'groupId': 'OG005'}, {'value': '-0.60', 'spread': '0.0819', 'groupId': 'OG006'}]}]}, {'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.0861', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.0806', 'groupId': 'OG001'}, {'value': '-0.64', 'spread': '0.0823', 'groupId': 'OG002'}, {'value': '-0.79', 'spread': '0.0823', 'groupId': 'OG003'}, {'value': '-0.60', 'spread': '0.0840', 'groupId': 'OG004'}, {'value': '-0.71', 'spread': '0.0811', 'groupId': 'OG005'}, {'value': '-0.66', 'spread': '0.0833', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects (participants with missing values at each timepoint were not included)'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'Mental component (week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.274', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '1.240', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '1.251', 'groupId': 'OG002'}, {'value': '7.3', 'spread': '1.244', 'groupId': 'OG003'}, {'value': '4.0', 'spread': '1.283', 'groupId': 'OG004'}, {'value': '5.7', 'spread': '1.230', 'groupId': 'OG005'}, {'value': '6.4', 'spread': '1.250', 'groupId': 'OG006'}]}]}, {'title': 'Mental component (week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.327', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.208', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '1.247', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '1.247', 'groupId': 'OG003'}, {'value': '5.3', 'spread': '1.271', 'groupId': 'OG004'}, {'value': '8.0', 'spread': '1.219', 'groupId': 'OG005'}, {'value': '7.1', 'spread': '1.246', 'groupId': 'OG006'}]}]}, {'title': 'Physical component (week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.030', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '0.999', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '1.010', 'groupId': 'OG002'}, {'value': '9.5', 'spread': '1.002', 'groupId': 'OG003'}, {'value': '6.8', 'spread': '1.028', 'groupId': 'OG004'}, {'value': '7.3', 'spread': '0.994', 'groupId': 'OG005'}, {'value': '8.4', 'spread': '1.006', 'groupId': 'OG006'}]}]}, {'title': 'Physical component (week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.149', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.045', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '1.080', 'groupId': 'OG002'}, {'value': '10.9', 'spread': '1.076', 'groupId': 'OG003'}, {'value': '7.7', 'spread': '1.094', 'groupId': 'OG004'}, {'value': '8.2', 'spread': '1.057', 'groupId': 'OG005'}, {'value': '8.2', 'spread': '1.077', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects (participants with missing values at each timepoint were not included)'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Fatigue Severity (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-14.3', 'spread': '3.146', 'groupId': 'OG000'}, {'value': '-20.8', 'spread': '3.060', 'groupId': 'OG001'}, {'value': '-19.4', 'spread': '3.077', 'groupId': 'OG002'}, {'value': '-27.4', 'spread': '3.077', 'groupId': 'OG003'}, {'value': '-21.7', 'spread': '3.180', 'groupId': 'OG004'}, {'value': '-18.6', 'spread': '3.056', 'groupId': 'OG005'}, {'value': '-26.3', 'spread': '3.080', 'groupId': 'OG006'}]}]}, {'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-12.9', 'spread': '3.306', 'groupId': 'OG000'}, {'value': '-23.9', 'spread': '3.052', 'groupId': 'OG001'}, {'value': '-22.3', 'spread': '3.131', 'groupId': 'OG002'}, {'value': '-31.3', 'spread': '3.103', 'groupId': 'OG003'}, {'value': '-17.7', 'spread': '3.184', 'groupId': 'OG004'}, {'value': '-23.4', 'spread': '3.056', 'groupId': 'OG005'}, {'value': '-27.0', 'spread': '3.134', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects (participants with missing values at each timepoint were not included)'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '3.273', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '3.443', 'groupId': 'OG001'}, {'value': '-8.7', 'spread': '3.673', 'groupId': 'OG002'}, {'value': '-12.0', 'spread': '3.081', 'groupId': 'OG003'}, {'value': '-13.7', 'spread': '3.285', 'groupId': 'OG004'}, {'value': '-10.0', 'spread': '3.575', 'groupId': 'OG005'}, {'value': '-11.7', 'spread': '6.281', 'groupId': 'OG006'}]}]}, {'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-10.7', 'spread': '4.033', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.893', 'groupId': 'OG001'}, {'value': '-17.1', 'spread': '4.200', 'groupId': 'OG002'}, {'value': '-12.1', 'spread': '3.448', 'groupId': 'OG003'}, {'value': '-5.9', 'spread': '3.788', 'groupId': 'OG004'}, {'value': '-12.6', 'spread': '3.938', 'groupId': 'OG005'}, {'value': '-4.7', 'spread': '6.379', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'The WPAI yeilds four types of scores:\n\n1. Absenteeism (work time missed)\n2. Presenteesism (impairment at work / reduced on-the-job effectiveness)\n3. Work productivty loss (overall work impairment / absenteeism plus presenteeism)\n4. Activity Impairment WPAI outcomes are expressed as impairment percentages with each subscale score ranging from 0-100. The subscale scores are added and averaged to produce a total WPAI score between 0-100. Higher scores indicate greater impairment and less productivity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects (participants with missing values at each timepoint were not included)'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'title': 'Erosion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.352', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.341', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.356', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.334', 'groupId': 'OG003'}, {'value': '1.0', 'spread': '0.369', 'groupId': 'OG004'}, {'value': '-0.2', 'spread': '0.341', 'groupId': 'OG005'}, {'value': '-0.5', 'spread': '0.348', 'groupId': 'OG006'}]}]}, {'title': 'Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.009', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '0.993', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '1.015', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '0.998', 'groupId': 'OG003'}, {'value': '-4.6', 'spread': '1.036', 'groupId': 'OG004'}, {'value': '-5.1', 'spread': '0.993', 'groupId': 'OG005'}, {'value': '-3.1', 'spread': '1.008', 'groupId': 'OG006'}]}]}, {'title': 'Synovitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.436', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '0.427', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.440', 'groupId': 'OG002'}, {'value': '-2.2', 'spread': '0.426', 'groupId': 'OG003'}, {'value': '-2.9', 'spread': '0.447', 'groupId': 'OG004'}, {'value': '-2.5', 'spread': '0.427', 'groupId': 'OG005'}, {'value': '-2.9', 'spread': '0.435', 'groupId': 'OG006'}]}]}, {'title': 'Narrowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.130', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.135', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.126', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.139', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.129', 'groupId': 'OG005'}, {'value': '-0.2', 'spread': '0.132', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'unitOfMeasure': 'cubic millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects (participants with missing values at each timepoint were not included)'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}, {'value': '54', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'OG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.353', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.320', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.327', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.324', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.330', 'groupId': 'OG004'}, {'value': '0.1', 'spread': '0.336', 'groupId': 'OG005'}, {'value': '0.1', 'spread': '0.333', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'The Sharp-van der Heijde total score ranges from 0-528. Scores for erosion range from 0 to 5 in the hands and 0 to 10 in the feet and reflect erosion size, with 0 defined as no erosion and 3 defined as a large erosion passing the midline of the joint. If there is \\> 1 erosion per joint, scores can be combined to give a maximum score of 5 per joint in the hands and 10 per joint in the feet (a maximum of 5 at each side of the joint). Joint space narrowing scores vary from 0 to 4 in both the hands and feet, with 0 being normal and 4 being the absence of joint space with evident ankylosis or subluxation. Gross osteolysis and pencil-in-cup change are scored separately and, if present, are assigned the maximum score for erosion and joint space narrowing for the same affected joint. Higher scores indicate increased joint damage.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated subjects (participants with missing values at each timepoint were not included)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'FG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'FG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'FG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'FG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'FG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'FG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '60'}, {'groupId': 'FG006', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '59'}, {'groupId': 'FG004', 'numSubjects': '54'}, {'groupId': 'FG005', 'numSubjects': '56'}, {'groupId': 'FG006', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '59'}, {'groupId': 'FG004', 'numSubjects': '54'}, {'groupId': 'FG005', 'numSubjects': '55'}, {'groupId': 'FG006', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '52'}, {'groupId': 'FG005', 'numSubjects': '55'}, {'groupId': 'FG006', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'subject request to discontinue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}, {'value': '418', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo+MTX', 'description': 'BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo\n\nBMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'BG001', 'title': 'Clazakizumab(25)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'BG002', 'title': 'Clazakizumab(100)', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'BG003', 'title': 'Clazakizumab(100)+MTX', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'BG004', 'title': 'Clazakizumab(200)', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'BG005', 'title': 'Clazakizumab(200)+MTX', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo\n\nBMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks\n\nMethotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only\n\nAdalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks'}, {'id': 'BG006', 'title': 'ADA+MTX', 'description': 'Adalimumab(ADA) + Methotrexate\n\nMethotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks\n\nAdalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}, {'value': '366', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '11.03', 'groupId': 'BG000'}, {'value': '47.4', 'spread': '10.97', 'groupId': 'BG001'}, {'value': '55.0', 'spread': '12.21', 'groupId': 'BG002'}, {'value': '49.9', 'spread': '13.95', 'groupId': 'BG003'}, {'value': '50.0', 'spread': '12.53', 'groupId': 'BG004'}, {'value': '46.4', 'spread': '11.91', 'groupId': 'BG005'}, {'value': '52.8', 'spread': '11.41', 'groupId': 'BG006'}, {'value': '50.4', 'spread': '12.26', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}, {'value': '343', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '75', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 418}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2015-07-24', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2011-06-13', 'dispFirstSubmitQcDate': '2015-07-24', 'resultsFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2011-06-13', 'dispFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-03', 'studyFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate', 'timeFrame': 'At 12 Weeks', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants With ACR 20 Response', 'timeFrame': 'At 24 weeks', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).'}, {'measure': 'Percent of Participants Achieving ACR 50 Response Rate', 'timeFrame': 'At weeks 12 and 24', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).'}, {'measure': 'Percent of Participants Achieving ACR 70 Response Rate', 'timeFrame': 'At weeks 12 and 24', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).'}, {'measure': 'Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.'}, {'measure': 'Percent of Participants With Remission by DAS28-CRP', 'timeFrame': 'At weeks 12 and 24', 'description': 'DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.'}, {'measure': 'Mean Change From Baseline in Clinical Disease Activity Index (CDAI)', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.\n\nCDAI \\<= 2.8 = Remission CDAI \\> 2.8 and \\<= 10 = Low Disease Activity CDAI \\> 10 and \\<= 22 = Moderate Disease Activity CDAI \\> 22 = High Disease Activity'}, {'measure': 'Percent of Participants With Remission by CDAI', 'timeFrame': 'At weeks 12 and 24', 'description': 'CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.\n\nCDAI \\<= 2.8 = Remission CDAI \\> 2.8 and \\<= 10 = Low Disease Activity CDAI \\> 10 and \\<= 22 = Moderate Disease Activity CDAI \\> 22 = High Disease Activity'}, {'measure': 'Mean Change From Baseline in Simplified Disease Activity Index (SDAI)', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.\n\n0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity'}, {'measure': 'Percent of Participants With Remission by SDAI', 'timeFrame': 'At weeks 12 and 24', 'description': 'SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.\n\n0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity'}, {'measure': 'Percent of Participants With Remission Rate by Boolean Definition', 'timeFrame': 'At weeks 12 and 24', 'description': 'Boolean-based definition:\n\nAt any time point, a patient must satisfy all of the following:\n\nTJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)'}, {'measure': 'Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.'}, {'measure': 'Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.'}, {'measure': 'Mean Change From Baseline in Fatigue Severity (VAS) Score', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.'}, {'measure': 'Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores', 'timeFrame': 'Baseline, weeks 12 and 24', 'description': 'The WPAI yeilds four types of scores:\n\n1. Absenteeism (work time missed)\n2. Presenteesism (impairment at work / reduced on-the-job effectiveness)\n3. Work productivty loss (overall work impairment / absenteeism plus presenteeism)\n4. Activity Impairment WPAI outcomes are expressed as impairment percentages with each subscale score ranging from 0-100. The subscale scores are added and averaged to produce a total WPAI score between 0-100. Higher scores indicate greater impairment and less productivity.'}, {'measure': 'Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing)', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score', 'timeFrame': 'Baseline and week 24', 'description': 'The Sharp-van der Heijde total score ranges from 0-528. Scores for erosion range from 0 to 5 in the hands and 0 to 10 in the feet and reflect erosion size, with 0 defined as no erosion and 3 defined as a large erosion passing the midline of the joint. If there is \\> 1 erosion per joint, scores can be combined to give a maximum score of 5 per joint in the hands and 10 per joint in the feet (a maximum of 5 at each side of the joint). Joint space narrowing scores vary from 0 to 4 in both the hands and feet, with 0 being normal and 4 being the absence of joint space with evident ankylosis or subluxation. Gross osteolysis and pencil-in-cup change are scored separately and, if present, are assigned the maximum score for erosion and joint space narrowing for the same affected joint. Higher scores indicate increased joint damage.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '26138593', 'type': 'DERIVED', 'citation': 'Weinblatt ME, Mease P, Mysler E, Takeuchi T, Drescher E, Berman A, Xing J, Zilberstein M, Banerjee S, Emery P. The efficacy and safety of subcutaneous clazakizumab in patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate: results from a multinational, phase IIb, randomized, double-blind, placebo/active-controlled, dose-ranging study. Arthritis Rheumatol. 2015 Oct;67(10):2591-600. doi: 10.1002/art.39249.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inadequate response to Methotrexate\n* Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization\n* American College of Rheumatology (ACR) global function status class 1-3\n* Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist\n* High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL\n\nExclusion Criteria:\n\n* Previously received or currently receiving concomitant biologic therapy'}, 'identificationModule': {'nctId': 'NCT01373151', 'briefTitle': 'Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.', 'orgStudyIdInfo': {'id': 'IM133-001'}, 'secondaryIdInfos': [{'id': '2010-023956-99', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1', 'description': 'BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo', 'interventionNames': ['Drug: BMS-945429 Placebo', 'Biological: BMS-945429', 'Drug: Methotrexate', 'Drug: Adalimumab Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo', 'interventionNames': ['Biological: BMS-945429', 'Drug: Methotrexate', 'Drug: Adalimumab Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo', 'interventionNames': ['Biological: BMS-945429', 'Drug: Methotrexate', 'Drug: Adalimumab Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'BMS-945429 + Methotrexate + Adalimumab Placebo', 'interventionNames': ['Biological: BMS-945429', 'Drug: Methotrexate', 'Drug: Adalimumab Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo', 'interventionNames': ['Biological: BMS-945429', 'Drug: Methotrexate Placebo', 'Drug: Methotrexate', 'Drug: Adalimumab Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6', 'description': 'BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo', 'interventionNames': ['Biological: BMS-945429', 'Drug: Methotrexate Placebo', 'Drug: Methotrexate', 'Drug: Adalimumab Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 7', 'description': 'Adalimumab + Methotrexate', 'interventionNames': ['Drug: Methotrexate', 'Drug: Adalimumab']}], 'interventions': [{'name': 'BMS-945429 Placebo', 'type': 'DRUG', 'description': 'Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only', 'armGroupLabels': ['Arm 1']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only', 'armGroupLabels': ['Arm 4']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks', 'armGroupLabels': ['Arm 3', 'Arm 6']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48', 'armGroupLabels': ['Arm 1', 'Arm 4']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks', 'armGroupLabels': ['Arm 2', 'Arm 5']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only', 'armGroupLabels': ['Arm 1']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Tablets, Oral, 15 mg, Weekly, 48 weeks', 'armGroupLabels': ['Arm 2', 'Arm 3', 'Arm 4', 'Arm 7']}, {'name': 'Methotrexate Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only', 'armGroupLabels': ['Arm 5', 'Arm 6']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only', 'armGroupLabels': ['Arm 5', 'Arm 6']}, {'name': 'Adalimumab Placebo', 'type': 'DRUG', 'description': 'Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4', 'Arm 5', 'Arm 6']}, {'name': 'Adalimumab', 'type': 'DRUG', 'description': 'Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks', 'armGroupLabels': ['Arm 7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sun Valley Arthritis Center, Ltd.', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Arthritis Medical Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06611', 'city': 'Trumbull', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Research Associates, Llc', 'geoPoint': {'lat': 41.24287, 'lon': -73.20067}}, {'zip': '62301', 'city': 'Quincy', 'state': 'Illinois', 'country': 'United 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