Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-01 @ 9:49 AM
Study NCT ID:
NCT05516758
Status:
TERMINATED
Last Update Posted:
2025-12-04
First Post:
2022-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '08005455979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to end of follow-up (up to 72 weeks)', 'description': 'All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Peresolimab 1000 mg SC Q4W (Discontinued Before Week 24)', 'description': 'Participants who received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 (discontinued before Week 24) were reported under this group.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q4W', 'description': 'Participants who received peresolimab 1000 mg SC Q4W from Week 0 to Week 24, then continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60 were reported under this group.', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 70, 'seriousNumAtRisk': 103, 'deathsNumAffected': 1, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W', 'description': 'Participants who received peresolimab 1000 mg SC Q4W from Week 0 to Week 24, then switched to peresolimab 1000 mg SC Q12W from Week 24 to Week 60 were reported under this group.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 16, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Peresolimab 400 mg SC Q4W (Discontinued Before Week 24)', 'description': 'Participants who received peresolimab 400 mg SC Q4W from Week 0 to Week 24 (discontinued before Week 24) were reported under this group.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 9, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q4W', 'description': 'Participants who received peresolimab 400 mg SC Q4W from Week 0 to Week 24, then continued peresolimab 400 mg SC Q4W from Week 24 to Week 60 were reported under this group.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 60, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG005', 'title': 'Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W', 'description': 'Participants who received peresolimab 400 mg SC Q4W from Week 0 to Week 24, then switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60 were reported under this group.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 13, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'Participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported under this group.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 48, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Placebo SC Q4W Only', 'description': 'Participants who received peresolimab matched Placebo SC Q4W only from Week 0 to Week 12 were reported under this group.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 9, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'Placebo SC Q4W to Peresolimab 1000 mg SC Q4W', 'description': 'Participants who received peresolimab-matched Placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60 were reported under this group.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 40, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG009', 'title': 'Placebo SC Q4W to Peresolimab 400 mg SC Q4W', 'description': 'Participants who received peresolimab-matched Placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60 were reported under this group.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 29, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial escape rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Left atrial enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab -matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '43.5', 'upperLimit': '60.0'}, {'value': '51.1', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': '59.3'}, {'value': '44.1', 'groupId': 'OG002', 'lowerLimit': '32.3', 'upperLimit': '55.9'}, {'value': '39.3', 'groupId': 'OG003', 'lowerLimit': '31.2', 'upperLimit': '47.4'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '1.14', 'ciUpperLimit': '3.11', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.098', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '0.92', 'ciUpperLimit': '2.52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.534', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.66', 'ciUpperLimit': '2.23', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The ACR20 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR20 responders were participants with at least 20% improvement from baseline in tender joint count (TJC) and swollen joint count (SJC), and at least 20% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response= (number of ACR20 responders)/ (number of participants analyzed) \\*100.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug. Non-Responder Imputation (NRI) was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab -matched Placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '29.6'}, {'value': '19.1', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '25.6'}, {'value': '11.8', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '19.4'}, {'value': '10.7', 'groupId': 'OG003', 'lowerLimit': '5.6', 'upperLimit': '15.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The ACR50 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR50 responders were participants with at least 50% improvement from baseline in TJC and SJC, and at least 50% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, HAQ-DI which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \\* 100.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70) Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '11.3'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '10.4'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '13.6'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '5.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The ACR70 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR70 responders were participants with at least 70% improvement from baseline in TJC and SJC, and at least 70% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, HAQ-DI which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \\* 100.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP) ≤3.2 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '24.0'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '23.2'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '8.6', 'upperLimit': '26.7'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '2.9', 'upperLimit': '11.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "DAS28-hsCRP LDA was defined as DAS28-hsCRP score of ≤3.2. The Disease Activity Score (DAS) based on 28 joint counts consisted of a composite numerical score derived from the following variables: tender joint count (0 to 28), swollen joint count (0 to 28), high-sensitivity C-reactive protein (hsCRP, mg/mL), and the patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56\\*square root (sqrt) (TJC28) plus (+) 0.28\\*sqrt (SJC28)+ 0.014\\* participant's global assessment of disease activity+ 0.36\\*natural log(hsCRP+1) + 0.96. Total Scores ranged from 1.0 to 9.4, with lower scores indicating less disease activity.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Remission According to DAS28-hsCRP Score <2.6 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '16.6'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '14.9'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '11.5'}, {'value': '4.3', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '7.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "DAS28-hsCRP remission is defined as DAS28-hsCRP \\<2.6. DAS based on 28 joints consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP=0.56\\*sqrt (TJC28) + 0.28\\*sqrt (SJC28) + 0.014\\* patient's global assessment of disease activity + 0.36\\*natural log(hsCRP+1) +0.96. Total Scores ranged from 1.0-9.4, where lower scores indicated less disease activity.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving LDA According to Clinical Disease Activity Index (CDAI) Score ≤10 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '29.6'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '27.2'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '8.6', 'upperLimit': '26.7'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '6.7', 'upperLimit': '17.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "Low disease activity was defined as a CDAI score of ≤10. CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Remission According to CDAI Score ≤2.8 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '5.6'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '9.5'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.3'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "Remission was defined as a CDAI score of ≤2.8. CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28-hsCRP Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'groupId': 'OG000', 'lowerLimit': '-1.89', 'upperLimit': '-1.46'}, {'value': '-1.41', 'groupId': 'OG001', 'lowerLimit': '-1.63', 'upperLimit': '-1.19'}, {'value': '-1.29', 'groupId': 'OG002', 'lowerLimit': '-1.59', 'upperLimit': '-0.99'}, {'value': '-1.08', 'groupId': 'OG003', 'lowerLimit': '-1.30', 'upperLimit': '-0.85'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "DAS based on 28 joints consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP = 0.56\\*sqrt (TJC28) + 0.28\\*sqrt (SJC28)+ 0.014\\* patient's global assessment of disease activity + 0.36\\*natural log(hsCRP+1) +0.96. Total scores ranged 1.0-9.4; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) with treatment, stratification factors, baseline value, visit, treatment-by-visit interaction as fixed factors and participant as a random factor.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug and had data for DAS28-hsCRP. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CDAI Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.98', 'groupId': 'OG000', 'lowerLimit': '-22.34', 'upperLimit': '-17.63'}, {'value': '-17.20', 'groupId': 'OG001', 'lowerLimit': '-19.64', 'upperLimit': '-14.77'}, {'value': '-15.42', 'groupId': 'OG002', 'lowerLimit': '-18.63', 'upperLimit': '-12.21'}, {'value': '-14.04', 'groupId': 'OG003', 'lowerLimit': '-16.48', 'upperLimit': '-11.60'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity(scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity).CDAI is calculated by summing values of 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. Negative change from baseline indicates improvement. LS Mean was calculated using MMRM with treatment, stratification factors, baseline value, visit, treatment-by-visit interaction as fixed factors and participant as a random factor.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug and had data for CDAI. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAQ-DI Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'OG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-0.53', 'upperLimit': '-0.35'}, {'value': '-0.42', 'groupId': 'OG001', 'lowerLimit': '-0.51', 'upperLimit': '-0.32'}, {'value': '-0.23', 'groupId': 'OG002', 'lowerLimit': '-0.35', 'upperLimit': '-0.10'}, {'value': '-0.26', 'groupId': 'OG003', 'lowerLimit': '-0.36', 'upperLimit': '-0.17'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'HAQ-DI was a patient-reported questionnaire used in rheumatoid arthritis to assess physical function over the past week. It covered 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Total score was computed as the sum of domain scores and divided by the number of domains answered. The total score ranges from 0 to 3, with higher scores indicating greater physical limitations. LS Mean was calculated using MMRM with treatment, stratification factors, baseline value, visit and treatment-by-visit interaction as fixed effects and participant as a random effect.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug and had data for HAQ-DI outcome. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Concentration of Peresolimab by Treatment-Emergent Anti-Drug Antibody (TE ADA) Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'OG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}], 'classes': [{'title': 'TE-ADA Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2060', 'spread': '28', 'groupId': 'OG001'}, {'value': '487', 'spread': '248', 'groupId': 'OG002'}]}]}, {'title': 'TE-ADA Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14700', 'spread': '113', 'groupId': 'OG000'}, {'value': '4800', 'spread': '155', 'groupId': 'OG001'}, {'value': '1150', 'spread': '152', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline through Week 12', 'description': 'Minimum observed concentration of peresolimab was assessed and stratified by Treatment-Emergent Anti-Drug Antibody (TE-ADA) status (TE ADA positive and TE ADA negative).\n\nA TE ADA evaluable participant was defined as TE ADA positive if they met the following criteria:\n\n1. Had baseline status of ADA Not Present and at least 1 postbaseline status of ADA Present with titer ≥ 2×minimum required dilution (MRD) of the ADA assay (Treatment Induced TE ADA). The MRD of peresolimab is 1:10.\n2. Had baseline and postbaseline status of ADA Present, with the postbaseline titer being 2 dilutions (4-fold) greater than the baseline titer.\n\nTE-ADA negative participants were defined as those not meeting the TE ADA positive criteria.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received atleast one dose of study drug and had TE-ADA data for this outcome. Participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups). No study participant treated with peresolimab 1000 mg Q4W had a positive TE-ADA result up to Week 12; thus, zero participants analyzed and no data were collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'Participants received peresolimab 1000 milligram (mg) subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 24. At Week 24, based on their Clinical Disease Activity Index (CDAI) score, participants continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60.'}, {'id': 'FG001', 'title': 'Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W', 'description': 'Participants received peresolimab 1000 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 1000 mg SC once every 12 weeks (Q12W) from Week 24 to Week 60.'}, {'id': 'FG002', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants continued peresolimab 400 mg SC Q4W from Week 24 to Week 60.'}, {'id': 'FG003', 'title': 'Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W', 'description': 'Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60.'}, {'id': 'FG004', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'Participants received peresolimab 100 mg SC Q4W from Week 0 to Week 60.'}, {'id': 'FG005', 'title': 'Placebo SC Q4W to Peresolimab 1000 mg SC Q4W', 'description': 'Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60.'}, {'id': 'FG006', 'title': 'Placebo SC Q4W to Peresolimab 400 mg SC Q4W', 'description': 'Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '69'}, {'groupId': 'FG005', 'numSubjects': '73'}, {'groupId': 'FG006', 'numSubjects': '67'}]}, {'type': 'Received Atleast One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '68'}, {'groupId': 'FG005', 'numSubjects': '73'}, {'groupId': 'FG006', 'numSubjects': '67'}]}, {'type': 'Peresolimab 1000 mg Q4W (Discontinued Before Week 24)', 'comment': 'Safety Analysis Population: All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received throughout the study period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Peresolimab 1000 mg Q4W to Peresolimab 1000 mg Q4W', 'comment': 'Safety Analysis Population: Participants who received peresolimab 1000 mg SC Q4W throughout the study (Weeks 0-60).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Peresolimab 400 mg Q4W (Discontinued Before Week 24)', 'comment': 'Safety Analysis Population: All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received throughout the study period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Peresolimab 400 mg Q4W to Peresolimab 400 mg Q4W', 'comment': 'Safety Analysis Population: Participants who received peresolimab 400 mg SC Q4W throughout the study (Weeks 0-60).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '94'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Placebo SC Q4W Only', 'comment': 'Safety Analysis Population: Placebo SC Q4W only = 14: Included 7 participants from the "Placebo to peresolimab 1000 mg Q4W" arm and 7 participants from the "Placebo to peresolimab 400 mg SC Q4W" arm who received placebo SC Q4W only and discontinued before Week 12. For analyses, based on the actual treatment received, these participants were analyzed together.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '7'}]}, {'type': 'Placebo SC Q4W to Peresolimab 1000 mg SC Q4W', 'comment': 'Safety Analysis Population: All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received throughout the study period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '66'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Placebo SC Q4W to Peresolimab 400 mg SC Q4W', 'comment': 'Safety Analysis Population: All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received throughout the study period.', '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': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '73'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '48'}, {'groupId': 'FG005', 'numSubjects': '47'}, {'groupId': 'FG006', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'Assigned treatment by mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'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': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Other- As reported by the site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Non-compliance With Study Drug', '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': '0'}]}, {'type': 'Site Terminated by Sponsor', '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'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Participants not proceeding to Follow-up phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'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': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}, {'value': '490', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Peresolimab 1000 mg SC Q4W', 'description': 'All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'BG001', 'title': 'Peresolimab 400 mg SC Q4W', 'description': 'All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.'}, {'id': 'BG002', 'title': 'Peresolimab 100 mg SC Q4W', 'description': 'All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.'}, {'id': 'BG003', 'title': 'Placebo SC Q4W', 'description': 'All participants received peresolimab-matched Placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.20', 'spread': '11.73', 'groupId': 'BG000'}, {'value': '54.50', 'spread': '11.56', 'groupId': 'BG001'}, {'value': '54.40', 'spread': '12.08', 'groupId': 'BG002'}, {'value': '54.00', 'spread': '10.15', 'groupId': 'BG003'}, {'value': '54.00', 'spread': '11.28', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '404', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '267', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '215', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}, {'value': '364', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '135', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-31', 'size': 2307858, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-19T19:12', 'hasProtocol': True}, {'date': '2024-12-01', 'size': 2473731, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-19T19:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 491}}, 'statusModule': {'whyStopped': 'Study terminated due to an unfavourable benefit-risk profile observed in interim data analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'dispFirstSubmitDate': '2024-05-01', 'completionDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2022-08-24', 'resultsFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2022-08-24', 'dispFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-20', 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Response at Week 12', 'timeFrame': 'Week 12', 'description': "The ACR20 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR20 responders were participants with at least 20% improvement from baseline in tender joint count (TJC) and swollen joint count (SJC), and at least 20% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response= (number of ACR20 responders)/ (number of participants analyzed) \\*100."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 12', 'timeFrame': 'Week 12', 'description': "The ACR50 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR50 responders were participants with at least 50% improvement from baseline in TJC and SJC, and at least 50% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, HAQ-DI which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \\* 100."}, {'measure': 'Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70) Response at Week 12', 'timeFrame': 'Week 12', 'description': "The ACR70 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR70 responders were participants with at least 70% improvement from baseline in TJC and SJC, and at least 70% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, HAQ-DI which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \\* 100."}, {'measure': 'Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP) ≤3.2 at Week 12', 'timeFrame': 'Week 12', 'description': "DAS28-hsCRP LDA was defined as DAS28-hsCRP score of ≤3.2. The Disease Activity Score (DAS) based on 28 joint counts consisted of a composite numerical score derived from the following variables: tender joint count (0 to 28), swollen joint count (0 to 28), high-sensitivity C-reactive protein (hsCRP, mg/mL), and the patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56\\*square root (sqrt) (TJC28) plus (+) 0.28\\*sqrt (SJC28)+ 0.014\\* participant's global assessment of disease activity+ 0.36\\*natural log(hsCRP+1) + 0.96. Total Scores ranged from 1.0 to 9.4, with lower scores indicating less disease activity."}, {'measure': 'Percentage of Participants With Remission According to DAS28-hsCRP Score <2.6 at Week 12', 'timeFrame': 'Week 12', 'description': "DAS28-hsCRP remission is defined as DAS28-hsCRP \\<2.6. DAS based on 28 joints consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP=0.56\\*sqrt (TJC28) + 0.28\\*sqrt (SJC28) + 0.014\\* patient's global assessment of disease activity + 0.36\\*natural log(hsCRP+1) +0.96. Total Scores ranged from 1.0-9.4, where lower scores indicated less disease activity."}, {'measure': 'Percentage of Participants Achieving LDA According to Clinical Disease Activity Index (CDAI) Score ≤10 at Week 12', 'timeFrame': 'Week 12', 'description': "Low disease activity was defined as a CDAI score of ≤10. CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity."}, {'measure': 'Percentage of Participants Achieving Remission According to CDAI Score ≤2.8 at Week 12', 'timeFrame': 'Week 12', 'description': "Remission was defined as a CDAI score of ≤2.8. CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity."}, {'measure': 'Change From Baseline in DAS28-hsCRP Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "DAS based on 28 joints consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP = 0.56\\*sqrt (TJC28) + 0.28\\*sqrt (SJC28)+ 0.014\\* patient's global assessment of disease activity + 0.36\\*natural log(hsCRP+1) +0.96. Total scores ranged 1.0-9.4; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) with treatment, stratification factors, baseline value, visit, treatment-by-visit interaction as fixed factors and participant as a random factor."}, {'measure': 'Change From Baseline in CDAI Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity(scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity).CDAI is calculated by summing values of 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. Negative change from baseline indicates improvement. LS Mean was calculated using MMRM with treatment, stratification factors, baseline value, visit, treatment-by-visit interaction as fixed factors and participant as a random factor."}, {'measure': 'Change From Baseline in HAQ-DI Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'HAQ-DI was a patient-reported questionnaire used in rheumatoid arthritis to assess physical function over the past week. It covered 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Total score was computed as the sum of domain scores and divided by the number of domains answered. The total score ranges from 0 to 3, with higher scores indicating greater physical limitations. LS Mean was calculated using MMRM with treatment, stratification factors, baseline value, visit and treatment-by-visit interaction as fixed effects and participant as a random effect.'}, {'measure': 'Minimum Observed Concentration of Peresolimab by Treatment-Emergent Anti-Drug Antibody (TE ADA) Status', 'timeFrame': 'Baseline through Week 12', 'description': 'Minimum observed concentration of peresolimab was assessed and stratified by Treatment-Emergent Anti-Drug Antibody (TE-ADA) status (TE ADA positive and TE ADA negative).\n\nA TE ADA evaluable participant was defined as TE ADA positive if they met the following criteria:\n\n1. Had baseline status of ADA Not Present and at least 1 postbaseline status of ADA Present with titer ≥ 2×minimum required dilution (MRD) of the ADA assay (Treatment Induced TE ADA). The MRD of peresolimab is 1:10.\n2. Had baseline and postbaseline status of ADA Present, with the postbaseline titer being 2 dilutions (4-fold) greater than the baseline titer.\n\nTE-ADA negative participants were defined as those not meeting the TE ADA positive criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Arthritis', 'Joint Diseases', 'Musculoskeletal Diseases', 'Rheumatic Diseases', 'Connective Tissue Diseases', 'Autoimmune Diseases', 'Immune System Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/356796', 'label': 'A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (RESOLUTION-1)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria\n* Have moderately-to-severely active RA, at screening and baseline, defined by the presence of\n\n * ≥6 swollen joints based on 66 joint count, and\n * ≥6 tender joints based on 68 joint count.\n* Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.\n\nExclusion Criteria:\n\n* Have Class IV RA according to ACR revised criteria.\n* Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to\n\n * poorly controlled diabetes or hypertension\n * chronic kidney disease stage IIIb, IV, or V\n * symptomatic heart failure according to New York Heart Association Class II, III, or IV\n * myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization\n * severe chronic pulmonary disease, for example, requiring oxygen therapy\n * major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,\n\n * systemic lupus erythematosus\n * psoriatic arthritis\n * axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis\n * reactive arthritis\n * gout\n * scleroderma\n * polymyositis\n * dermatomyositis\n * active fibromyalgia, or\n * multiple sclerosis'}, 'identificationModule': {'nctId': 'NCT05516758', 'acronym': 'RESOLUTION-1', 'briefTitle': 'A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '18525'}, 'secondaryIdInfos': [{'id': 'J1A-MC-KDAF', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2022-501425-20-00', 'type': 'OTHER', 'domain': 'EU Trial Number'}, {'id': 'U1111-1283-9566', 'type': 'OTHER', 'domain': 'Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peresolimab 1000 mg SC Q4W', 'description': 'Participants received peresolimab 1000 milligram (mg) subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 24. At Week 24, based on their Clinical Disease Activity Index (CDAI) score, participants continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60.', 'interventionNames': ['Drug: Peresolimab']}, {'type': 'EXPERIMENTAL', 'label': 'Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W', 'description': 'Participants received peresolimab 1000 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 1000 mg SC once every 12 weeks (Q12W) from Week 24 to Week 60.', 'interventionNames': ['Drug: Peresolimab']}, {'type': 'EXPERIMENTAL', 'label': 'Peresolimab 400 mg SC Q4W', 'description': 'Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants continued peresolimab 400 mg SC Q4W from Week 24 to Week 60.', 'interventionNames': ['Drug: Peresolimab']}, {'type': 'EXPERIMENTAL', 'label': 'Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W', 'description': 'Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. 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Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}