Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT02504268
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2015-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'Saudi Arabia', 'United Arab Emirates']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email:', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'approximately 54 months', 'description': 'Participants from the Induction period (IP) cohorts randomized to the De-Escalation period. Participants from the induction period also entered the Open Label period. Participants from the De-Escalation period entered 1 of 2 the open label period or the open label extension period.', 'eventGroups': [{'id': 'EG000', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)', 'description': 'Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week', 'otherNumAtRisk': 451, 'deathsNumAtRisk': 451, 'otherNumAffected': 237, 'seriousNumAtRisk': 451, 'deathsNumAffected': 1, 'seriousNumAffected': 32}, {'id': 'EG001', 'title': 'Placebo + Methotrexate (Cohort 1, IP)', 'description': 'Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week', 'otherNumAtRisk': 301, 'deathsNumAtRisk': 301, 'otherNumAffected': 152, 'seriousNumAtRisk': 301, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)', 'description': 'Active abatacept SC (125 mg) weekly + methotrexate weekly', 'otherNumAtRisk': 242, 'deathsNumAtRisk': 242, 'otherNumAffected': 123, 'seriousNumAtRisk': 242, 'deathsNumAffected': 0, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Abatacept + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + MTX weekly', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 12, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Abatacept (End of Week) + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 22, 'seriousNumAtRisk': 50, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Abatacept Monotherapy (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + placebo MTX weekly', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 10, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Methotrexate Monotherapy (De-Escalation Period)', 'description': 'Placebo Abatacept SC weekly + methotrexate weekly', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 16, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Abatacept + Methotrexate (Open Label Period)', 'description': 'weekly abatacept SC 125 mg + methotrexate', 'otherNumAtRisk': 685, 'deathsNumAtRisk': 685, 'otherNumAffected': 230, 'seriousNumAtRisk': 685, 'deathsNumAffected': 1, 'seriousNumAffected': 40}, {'id': 'EG008', 'title': 'Abatacept + Methotrexate (Open Label Extension Period)', 'description': 'abatacept SC (125 mg) qw for 24 weeks', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 15, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 10}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 13}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 23}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 21}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Drug intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 24}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 13}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 59}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 18}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 28}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 26}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 20}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 11}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza A virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 20}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 11}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vaginal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Knee operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)', 'description': 'Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG001', 'title': 'Placebo + Methotrexate (Cohort 1, IP)', 'description': 'Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG002', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)', 'description': 'Active abatacept SC (125 mg) weekly + methotrexate weekly'}, {'id': 'OG003', 'title': 'Abatacept + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + MTX weekly'}, {'id': 'OG004', 'title': 'Abatacept (End of Week) + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly'}, {'id': 'OG005', 'title': 'Abatacept Monotherapy (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + placebo MTX weekly'}, {'id': 'OG006', 'title': 'Methotrexate Monotherapy (De-Escalation Period)', 'description': 'Placebo Abatacept SC weekly + methotrexate weekly'}, {'id': 'OG007', 'title': 'Abatacept + Methotrexate (Open Label Period)', 'description': 'weekly abatacept SC 125 mg + methotrexate'}, {'id': 'OG008', 'title': 'Abatacept + Methotrexate (Open Label Extension Period)', 'description': 'abatacept SC (125 mg) qw for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '26.7'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '21.9'}]}]}], 'analyses': [{'pValue': '0.2359', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \\<= 3.3.\n\nUsing a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \\<= 3.3 indicates disease remission and SDAI \\>26 = high disease activity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis population included the first 50 Japanese and 325 rest of world (ROW) randomized and treated subjects in cohort 1 in the Induction Period. Intention to treat analysis. Non-Responder imputation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)', 'description': 'Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG001', 'title': 'Placebo + Methotrexate (Cohort 1, IP)', 'description': 'Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG002', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)', 'description': 'Active abatacept SC (125 mg) weekly + methotrexate weekly'}, {'id': 'OG003', 'title': 'Abatacept + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + MTX weekly'}, {'id': 'OG004', 'title': 'Abatacept (End of Week) + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly'}, {'id': 'OG005', 'title': 'Abatacept Monotherapy (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + placebo MTX weekly'}, {'id': 'OG006', 'title': 'Methotrexate Monotherapy (De-Escalation Period)', 'description': 'Placebo Abatacept SC weekly + methotrexate weekly'}, {'id': 'OG007', 'title': 'Abatacept + Methotrexate (Open Label Period)', 'description': 'weekly abatacept SC 125 mg + methotrexate'}, {'id': 'OG008', 'title': 'Abatacept + Methotrexate (Open Label Extension Period)', 'description': 'abatacept SC (125 mg) qw for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '32.3', 'upperLimit': '45.0'}, {'value': '25.3', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '32.3'}]}]}], 'analyses': [{'pValue': '0.0112', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP \\<= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis population included the first 50 Japanese and 325 rest of world (ROW) randomized and treated subjects in cohort 1 in the Induction Period. Intention to treat analysis. Non-Responder imputation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in SDAI Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)', 'description': 'Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG001', 'title': 'Placebo + Methotrexate (Cohort 1, IP)', 'description': 'Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG002', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)', 'description': 'Active abatacept SC (125 mg) weekly + methotrexate weekly'}, {'id': 'OG003', 'title': 'Abatacept + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + MTX weekly'}, {'id': 'OG004', 'title': 'Abatacept (End of Week) + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly'}, {'id': 'OG005', 'title': 'Abatacept Monotherapy (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + placebo MTX weekly'}, {'id': 'OG006', 'title': 'Methotrexate Monotherapy (De-Escalation Period)', 'description': 'Placebo Abatacept SC weekly + methotrexate weekly'}, {'id': 'OG007', 'title': 'Abatacept + Methotrexate (Open Label Period)', 'description': 'weekly abatacept SC 125 mg + methotrexate'}, {'id': 'OG008', 'title': 'Abatacept + Methotrexate (Open Label Extension Period)', 'description': 'abatacept SC (125 mg) qw for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '35.8'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '21.1'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \\<= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \\<= 3.3 indicates disease remission and SDAI \\>26 = high disease activity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis population included the first 50 Japanese and 325 rest of world (ROW) randomized and treated subjects in cohort 1 in the Induction Period. Intention to treat analysis. Non-Responder imputation.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)', 'description': 'Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG001', 'title': 'Placebo + Methotrexate (Cohort 1, IP)', 'description': 'Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG002', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)', 'description': 'Active abatacept SC (125 mg) weekly + methotrexate weekly'}, {'id': 'OG003', 'title': 'Abatacept + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + MTX weekly'}, {'id': 'OG004', 'title': 'Abatacept (End of Week) + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly'}, {'id': 'OG005', 'title': 'Abatacept Monotherapy (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + placebo MTX weekly'}, {'id': 'OG006', 'title': 'Methotrexate Monotherapy (De-Escalation Period)', 'description': 'Placebo Abatacept SC weekly + methotrexate weekly'}, {'id': 'OG007', 'title': 'Abatacept + Methotrexate (Open Label Period)', 'description': 'weekly abatacept SC 125 mg + methotrexate'}, {'id': 'OG008', 'title': 'Abatacept + Methotrexate (Open Label Extension Period)', 'description': 'abatacept SC (125 mg) qw for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '2.279', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '6.205', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'rank-based ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.', 'unitOfMeasure': 'Total Sharp Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 1 analysis population included all randomized and treated subjects in the Induction Period. Intention to treat analysis. Linear extrapolation imputation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Boolean Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)', 'description': 'Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG001', 'title': 'Placebo + Methotrexate (Cohort 1, IP)', 'description': 'Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'OG002', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)', 'description': 'Active abatacept SC (125 mg) weekly + methotrexate weekly'}, {'id': 'OG003', 'title': 'Abatacept + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + MTX weekly'}, {'id': 'OG004', 'title': 'Abatacept (End of Week) + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly'}, {'id': 'OG005', 'title': 'Abatacept Monotherapy (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + placebo MTX weekly'}, {'id': 'OG006', 'title': 'Methotrexate Monotherapy (De-Escalation Period)', 'description': 'Placebo Abatacept SC weekly + methotrexate weekly'}, {'id': 'OG007', 'title': 'Abatacept + Methotrexate (Open Label Period)', 'description': 'weekly abatacept SC 125 mg + methotrexate'}, {'id': 'OG008', 'title': 'Abatacept + Methotrexate (Open Label Extension Period)', 'description': 'abatacept SC (125 mg) qw for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '25.3'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '15.2'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 1 analysis population included all randomized and treated subjects in the Induction Period. Intention to treat analysis. Non-Responder imputation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)', 'description': 'Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'FG001', 'title': 'Placebo + Methotrexate (Cohort 1, IP)', 'description': 'Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'FG002', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)', 'description': 'Active abatacept SC (125 mg) weekly + methotrexate weekly'}, {'id': 'FG003', 'title': 'Abatacept + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + MTX weekly'}, {'id': 'FG004', 'title': 'Abatacept (End of Week) + Methotrexate (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly'}, {'id': 'FG005', 'title': 'Abatacept Monotherapy (De-Escalation Period)', 'description': 'Active Abatacept SC (125 mg) weekly + placebo MTX weekly'}, {'id': 'FG006', 'title': 'Methotrexate Monotherapy (De-Escalation Period)', 'description': 'Placebo Abatacept SC weekly + methotrexate weekly'}, {'id': 'FG007', 'title': 'Abatacept + Methotrexate (Open Label Period)', 'description': 'weekly abatacept SC 125 mg + methotrexate'}, {'id': 'FG008', 'title': 'Abatacept + Methotrexate (Open Label Extension Period)', 'description': 'abatacept SC (125 mg) qw for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '= Started the Induction Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '451'}, {'groupId': 'FG001', 'numSubjects': '301'}, {'groupId': 'FG002', 'numSubjects': '242'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Induction to Open Label', 'comment': 'Number of participants who completed induction period and treated in Open Label Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '196'}, {'groupId': 'FG002', 'numSubjects': '147'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Early Escaped to Open Label', 'comment': 'Number of participants who early escaped and treated in open label period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Induction to De-Escalation', 'comment': 'Number of participants who completed induction period and treated in de-escalation period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Randomized in De-Escalation Period', 'comment': 'Participants after induction period randomized into De-Escalation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '50'}, {'groupId': 'FG005', 'numSubjects': '47'}, {'groupId': 'FG006', 'numSubjects': '37'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'De-Escalation to Open Label Extension', 'comment': 'Number of participants who completed De-escalation period and treated in Open Label Extension Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '30'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '22'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Early Escaped De-Escalation to Open Label Period', 'comment': 'Number of participants who early escaped the De-Escalation Period and treated in the Open Label Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Open Label and Open Label Extension Period', 'comment': 'Participants who entered Open Label and Open Label Extension Periods', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '685'}, {'groupId': 'FG008', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Completed Induction Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '388'}, {'groupId': 'FG001', 'numSubjects': '233'}, {'groupId': 'FG002', 'numSubjects': '201'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Subject Request to Discontinue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'No Longer Meets Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Poor/Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Not Disclosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '994 treated in the induction period (IP). 184 from IP randomized and treated in De-Escalation (DeE), 685 treated in the Open Label (OL) and 120 treated in the Open Label Extension (OLE) period. Participants in IP could move to the OL period after IP completion or through early IP escape. Participants from DeE could transfer to OL through early escape or to OLE after completing DeE.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)', 'description': 'Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'BG001', 'title': 'Placebo + Methotrexate (Cohort 1, IP)', 'description': 'Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week'}, {'id': 'BG002', 'title': 'Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)', 'description': 'Active abatacept SC (125 mg) weekly + methotrexate weekly'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '48.9', 'spread': '12.74', 'groupId': 'BG000'}, {'value': '48.8', 'spread': '13.99', 'groupId': 'BG001'}, {'value': '50.0', 'spread': '12.91', 'groupId': 'BG002'}, {'value': '49.1', 'spread': '13.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '781', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'WHITE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}, {'value': '698', 'groupId': 'BG003'}]}]}, {'title': 'BLACK/AFRICAN AMERICAN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'AMERICAN INDIAN/ALASKA NATIVE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'ASIAN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}, {'title': 'RACE - OTHER/ NOT REPORTED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}]}, {'title': 'HISPANIC OR LATINO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'NOT HISPANIC OR LATINO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}]}, {'title': 'ETHNICITY - NOT REPORTED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '994', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '400', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '860', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity data was collected for US Subjects only.'}, {'title': 'MODIFIED SHARP/VAN DER HEIJDE TOTAL SCORE (mTSS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '734', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9.82', 'spread': '16.342', 'groupId': 'BG000'}, {'value': '12.99', 'spread': '19.769', 'groupId': 'BG001'}, {'value': '11.08', 'spread': '17.839', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Cohort 1 Analysis Population'}, {'title': 'Tender Joints - 28', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '746', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13.2', 'spread': '6.76', 'groupId': 'BG000'}, {'value': '13.7', 'spread': '6.77', 'groupId': 'BG001'}, {'value': '13.4', 'spread': '6.76', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'number of painful joints from 28 joints', 'unitOfMeasure': 'Joint Count', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Cohort 1 Analysis Population'}, {'title': 'Swollen Joints - 28', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '746', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '5.71', 'groupId': 'BG000'}, {'value': '10.7', 'spread': '5.85', 'groupId': 'BG001'}, {'value': '10.3', 'spread': '5.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'number of swollen joints from 28 joints', 'unitOfMeasure': 'Joint Count', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Cohort 1 Analysis Population'}, {'title': 'Subject global assessment of disease activity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '751', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '65.7', 'spread': '22.7', 'groupId': 'BG000'}, {'value': '62.7', 'spread': '24.05', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '23.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Subject's global assessment of disease activity by using a Visual Analog Scale (VAS). The scale ranges from 0 mm to 100 mm, \\[0 mm=no pain to 100 mm=worst possible pain\\]", 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Cohort 1 Analysis Population'}, {'title': 'Physician global assessment of disease activity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '742', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '65.1', 'spread': '18.48', 'groupId': 'BG000'}, {'value': '66.1', 'spread': '19.75', 'groupId': 'BG001'}, {'value': '65.5', 'spread': '18.99', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "physician's global assessment of disease activity using a Visual Analog Scale (VAS). The scale ranges from 0 to 100 mm, \\[0=no arthritis activity to 100 =extremely active arthritis\\]", 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Cohort 1 Analysis Population'}, {'title': 'C-Reactive Protein (CRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '751', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.998', 'spread': '2.7062', 'groupId': 'BG000'}, {'value': '1.904', 'spread': '2.1956', 'groupId': 'BG001'}, {'value': '1.960', 'spread': '2.5129', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Cohort 1 Analysis Population'}, {'title': 'DAS28-CRP', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '744', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.56', 'spread': '1.062', 'groupId': 'BG000'}, {'value': '5.61', 'spread': '1.032', 'groupId': 'BG001'}, {'value': '5.58', 'spread': '1.049', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Disease Activity Score (DAS28-CRP) =0.56×sqrt(tender joints \\[count:1-28\\])+0.28×sqrt(swollen joints \\[count:1-28\\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \\[100=most severe\\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Cohort 1 Analysis Population'}, {'title': 'SDAI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'BG000'}, {'value': '294', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '737', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38.24', 'spread': '14.084', 'groupId': 'BG000'}, {'value': '39.36', 'spread': '13.770', 'groupId': 'BG001'}, {'value': '38.69', 'spread': '13.961', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Simple Disease Activity Index is the numerical sum of five outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on a visual analogue scale scale (range 0 to 10 cm), and C-reactive protein measured in mg/dL. SDAI total score range: 0 to 86. SDAI \\<= 3.3 indicates disease remission and SDAI \\>26 = high disease activity.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Cohort 1 Analysis Population'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 994}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2017-12-06', 'completionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-25', 'studyFirstSubmitDate': '2015-07-20', 'dispFirstSubmitQcDate': '2017-12-06', 'resultsFirstSubmitDate': '2019-01-16', 'studyFirstSubmitQcDate': '2015-07-20', 'dispFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-04', 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24', 'timeFrame': 'Week 24', 'description': 'Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \\<= 3.3.\n\nUsing a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \\<= 3.3 indicates disease remission and SDAI \\>26 = high disease activity.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24', 'timeFrame': 'Week 24', 'description': 'DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP \\<= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.'}, {'measure': 'Percentage of Participants in SDAI Remission at Week 52', 'timeFrame': 'Week 52', 'description': 'Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \\<= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \\<= 3.3 indicates disease remission and SDAI \\>26 = high disease activity.'}, {'measure': 'Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52', 'timeFrame': 'Week 52', 'description': 'The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.'}, {'measure': 'Percentage of Participants in Boolean Remission at Week 52', 'timeFrame': 'Week 52', 'description': 'Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '39814436', 'type': 'DERIVED', 'citation': 'Emery P, Fleischmann R, Wong R, Lozenski K, Tanaka Y, Bykerk V, Bingham CO 3rd, Huizinga TWJ, Citera G, Perera V, Murthy B, Maxwell KF, Passarell J, Hedrich WD, Williams D. Association Between Abatacept Exposure Levels and Infection Occurrence in Patients With Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study. J Rheumatol. 2025 May 1;52(5):426-435. doi: 10.3899/jrheum.2024-0498.'}, {'pmid': '37087459', 'type': 'DERIVED', 'citation': 'Emery P, Tanaka Y, Bykerk VP, Bingham CO, Huizinga TWJ, Citera G, Huang KG, Wu C, Connolly SE, Elbez Y, Wong R, Lozenski K, Fleischmann R. The trajectory of clinical responses in patients with early rheumatoid arthritis who achieve sustained remission in response to abatacept: subanalysis of AVERT-2, a randomized phase IIIb study. Arthritis Res Ther. 2023 Apr 22;25(1):67. doi: 10.1186/s13075-023-03038-2.'}, {'pmid': '36869251', 'type': 'DERIVED', 'citation': 'Emery P, Tanaka Y, Bykerk VP, Huizinga TWJ, Citera G, Bingham CO 3rd, Banerjee S, Soule BP, Nys M, Connolly SE, Lozenski KL, Zhuo J, Wong R, Huang KG, Fleischmann R. Sustained Remission and Outcomes with Abatacept plus Methotrexate Following Stepwise Dose De-escalation in Patients with Early Rheumatoid Arthritis. Rheumatol Ther. 2023 Jun;10(3):707-727. doi: 10.1007/s40744-022-00519-9. Epub 2023 Mar 3.'}, {'pmid': '36585217', 'type': 'DERIVED', 'citation': 'Wu C, Hu Y, Schafer P, Connolly SE, Wong R, Nielsen SH, Bay-Jensen AC, Emery P, Tanaka Y, Bykerk VP, Bingham CO, Huizinga TW, Fleischmann R, Liu J. Baseline serum levels of cross-linked carboxy-terminal telopeptide of type I collagen predict abatacept treatment response in methotrexate-naive, anticitrullinated protein antibody-positive patients with early rheumatoid arthritis. RMD Open. 2022 Dec;8(2):e002683. doi: 10.1136/rmdopen-2022-002683.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.', 'detailedDescription': 'Subcutaneous (SC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Rheumatoid arthritis (RA) diagnosis less than 6 months\n* CRP \\> 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h\n* At least 3 swollen and 3 tender joints\n* Anti-citrullinated protein antibodies (ACPA) positive\n\nExclusion Criteria:\n\n* At risk for tuberculosis\n* Have acute infection\n* Have chronic or recurrent bacterial or serious latent viral infection\n* History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma\n* Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)'}, 'identificationModule': {'nctId': 'NCT02504268', 'acronym': 'AVERT-2', 'briefTitle': 'Effects of Abatacept in Patients With Early Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive', 'orgStudyIdInfo': {'id': 'IM101-550'}, 'secondaryIdInfos': [{'id': '2015-001275-50', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination Therapy: Abatacept + Methotrexate', 'description': 'Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week', 'interventionNames': ['Drug: Abatacept', 'Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methotrexate treatment', 'description': 'Methotrexate at least 15mg per week tablet or capsule orally', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Abatacept Placebo', 'description': 'Placebo for Abatacept subcutaneous injection once per week', 'interventionNames': ['Other: Abatacept Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Methotrexate Placebo', 'description': 'Placebo to match Methotrexate capsule orally once per week', 'interventionNames': ['Other: Methotrexate Placebo']}], 'interventions': [{'name': 'Abatacept', 'type': 'DRUG', 'armGroupLabels': ['Combination Therapy: Abatacept + Methotrexate']}, {'name': 'Methotrexate', 'type': 'DRUG', 'armGroupLabels': ['Combination Therapy: Abatacept + Methotrexate', 'Methotrexate treatment']}, {'name': 'Abatacept Placebo', 'type': 'OTHER', 'armGroupLabels': ['Abatacept Placebo']}, {'name': 'Methotrexate Placebo', 'type': 'OTHER', 'armGroupLabels': ['Methotrexate Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheumatology Associates Of North Alabama, P.C.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research PLLC', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research PLLC', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research PLLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85037', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research PLLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research PLLC', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'CHI St. Vincent Medical Group Hot Springs', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Primary Care Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Heritage Medical Group', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92646', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Healthcare Partners Medical Group', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Valerius Medical Group and Research Center', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Inland Rheumatology Clinical Trials Inc.', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Joao Nascimento', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Rheumatology Associates Of Central Florida, P.A.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Medical Group, Pa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83814', 'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': "Coeur D'Alene Arthrit Clin", 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'zip': '71203', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Arthritis And Diabetes Clinic', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Klein And Associates, M.D., Pa', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '55121', 'city': 'Eagan', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St. Paul Rheumatology, P.A.', 'geoPoint': {'lat': 44.80413, 'lon': -93.16689}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Arthritis Consultants', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Physician Research Collaboration, Llc', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '07728', 'city': 'Freehold', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Arthritis And Osteoporosis Associates, Pa', 'geoPoint': {'lat': 40.26011, 'lon': -74.27376}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Physicians Research Center, Llc', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Albuquerque Center For Rheumatology', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Albuquerque Clinical Trials', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10021-4892', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital For Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pmg Research Of Salisbury', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Arthritis Associates', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pmg Research Of Wilmington Llc', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Health Research Of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Ctr For Arthritis Therapy And Research, Inc.', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center For Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '19152', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Arthritis Group', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research Center Of Reading, Llp', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'West Tennessee Research Institute', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Clinical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Institute For Clinical Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22205', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Arthritis Clinic Of 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Cordoba S.A.', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Centro De Investigaciones Reumatologicas', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Centro Medico Privado De Reumatologia', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '4558', 'city': 'Maroochydore', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -26.66008, 'lon': 153.09953}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 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