Viewing Study NCT03789292

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Ignite Creation Date: 2025-12-24 @ 3:31 PM
Ignite Modification Date: 2025-12-25 @ 3:47 PM
Study NCT ID: NCT03789292
Status: COMPLETED
Last Update Posted: 2021-11-17
First Post: 2018-12-27
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jiwoong.lim@celltrion.com', 'phone': '032-850-5806', 'title': 'JiWoong Lim', 'organization': 'Celltrion Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).', 'description': 'Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment 1: CT-P17', 'description': 'Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.', 'otherNumAtRisk': 324, 'deathsNumAtRisk': 324, 'otherNumAffected': 96, 'seriousNumAtRisk': 324, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Treatment 1: EU-approved Humira', 'description': 'Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.', 'otherNumAtRisk': 324, 'deathsNumAtRisk': 324, 'otherNumAffected': 118, 'seriousNumAtRisk': 324, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Treatment 2: CT-P17 Maintenance', 'description': 'All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.', 'otherNumAtRisk': 303, 'deathsNumAtRisk': 303, 'otherNumAffected': 50, 'seriousNumAtRisk': 303, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Treatment 2: Humira Maintenance', 'description': 'Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 35, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Treatment 2: Switched to CT-P17', 'description': 'Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 33, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitreous hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonalcoholic fatty liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extradural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb crushing injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign muscle neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amyotrophic lateral sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rheumatoid lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'American College of Rheumatology(ACR)20 Response Rate at Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P17 Subcutaneous(SC) (Adalimumab)', 'description': 'Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.\n\nTreatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.'}, {'id': 'OG001', 'title': 'EU-approved Humira SC (Adalimumab)', 'description': 'Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.\n\nTreatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.'}], 'classes': [{'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'ACR50 and ACR70 Response Rate at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P17', 'description': 'Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.'}, {'id': 'OG001', 'title': 'EU-approved Humira', 'description': 'Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.'}], 'classes': [{'title': 'ACR50 at Week 24', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 at Week 24', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'ACR20, ACR50, and ACR70 Response Rate up to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P17 Maintenance', 'description': 'All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.'}, {'id': 'OG001', 'title': 'Humira Maintenance', 'description': 'Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.'}, {'id': 'OG002', 'title': 'Switched to CT-P17', 'description': 'Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.'}], 'classes': [{'title': 'ACR20 at Week 52', 'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}]}, {'title': 'ACR50 at Week 52', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}, {'title': 'ACR70 at Week 52', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 52', 'description': 'ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P17', 'description': 'Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.'}, {'id': 'OG001', 'title': 'EU-approved Humira', 'description': 'Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.738', 'spread': '1.1911', 'groupId': 'OG000'}, {'value': '-2.734', 'spread': '1.2052', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': "The Disease activity score (DAS28) (c-reactive protein \\[CRP\\]) score was derived using the following formulae:\n\nDAS28 (CRP) = 0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.014\\*(GH) + 0.36\\*ln(CRP+1) + 0.96\n\nWhere:\n\nTJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).\n\nDAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P17 Maintenance', 'description': 'All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.'}, {'id': 'OG001', 'title': 'Humira Maintenance', 'description': 'Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.'}, {'id': 'OG002', 'title': 'Switched to CT-P17', 'description': 'Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.945', 'spread': '1.1273', 'groupId': 'OG000'}, {'value': '-3.074', 'spread': '1.1926', 'groupId': 'OG001'}, {'value': '-2.983', 'spread': '1.2529', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 52', 'description': "The Disease activity score (DAS28) (c-reactive protein \\[CRP\\]) score was derived using the following formulae:\n\nDAS28 (CRP) = 0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.014\\*(GH) + 0.36\\*ln(CRP+1) + 0.96\n\nWhere:\n\nTJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).\n\nDAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CT-P17 Subcutaneous(SC) (Adalimumab)', 'description': 'Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.\n\nTreatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.'}, {'id': 'FG001', 'title': 'EU-approved Humira SC (Adalimumab)', 'description': 'Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.\n\nTreatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.'}, {'id': 'FG002', 'title': 'Switched to CT-P17', 'description': 'Treatment Period 1: N/A\n\nTreatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.'}], 'periods': [{'title': 'Treatment Period I (Week 0 to Week 26)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '324'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}, {'groupId': 'FG001', 'numSubjects': '305'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Significant dose delay', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period II (Week 26 to Week 52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}, {'comment': 'Patients who had administrated Humira SC during Treatment Period 1 has been devided into 2 groups - maintaining Humira SC and switched to CT-P17.', 'groupId': 'FG001', 'numSubjects': '153'}, {'comment': 'Patients who had administrated Humira SC during Treatment Period 1 has been devided into 2 groups - maintaining Humira SC and switched to CT-P17.', 'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '147'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Significant dose delay', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Could not visit the site due to COVID-19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '648', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CT-P17', 'description': 'Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.'}, {'id': 'BG001', 'title': 'EU-approved Humira', 'description': 'Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '75'}, {'value': '54.0', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '75'}, {'value': '54.0', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-06', 'size': 2401485, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-03T04:33', 'hasProtocol': True}, {'date': '2020-06-19', 'size': 1800747, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-03T04:07', 'hasProtocol': False}]}}, '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': 648}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2018-12-27', 'resultsFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2018-12-27', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-20', 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American College of Rheumatology(ACR)20 Response Rate at Week 24.', 'timeFrame': 'Week 24', 'description': 'ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)'}], 'secondaryOutcomes': [{'measure': 'ACR50 and ACR70 Response Rate at Week 24', 'timeFrame': 'Week 24', 'description': 'ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.'}, {'measure': 'ACR20, ACR50, and ACR70 Response Rate up to Week 52', 'timeFrame': 'Up to Week 52', 'description': 'ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.'}, {'measure': 'Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)', 'timeFrame': 'Week 24', 'description': "The Disease activity score (DAS28) (c-reactive protein \\[CRP\\]) score was derived using the following formulae:\n\nDAS28 (CRP) = 0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.014\\*(GH) + 0.36\\*ln(CRP+1) + 0.96\n\nWhere:\n\nTJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).\n\nDAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity."}, {'measure': 'Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)', 'timeFrame': 'Up to Week 52', 'description': "The Disease activity score (DAS28) (c-reactive protein \\[CRP\\]) score was derived using the following formulae:\n\nDAS28 (CRP) = 0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.014\\*(GH) + 0.36\\*ln(CRP+1) + 0.96\n\nWhere:\n\nTJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).\n\nDAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '34142111', 'type': 'DERIVED', 'citation': 'Furst DE, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Kim SH, Bae YJ, Yang GE, Yoo JK, Kay J, Keystone E. Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis. Rheumatology (Oxford). 2022 Apr 11;61(4):1385-1395. doi: 10.1093/rheumatology/keab460.'}, {'pmid': '33546755', 'type': 'DERIVED', 'citation': 'Kay J, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Bae YJ, Yang GE, Yoo JK, Furst DE, Keystone E. Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study. Arthritis Res Ther. 2021 Feb 5;23(1):51. doi: 10.1186/s13075-020-02394-7.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis', 'detailedDescription': 'CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is male or female aged 18 to 75 years old, both inclusive.\n* Patient has had a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology(ACR)/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug .\n\nExclusion Criteria:\n\n* Patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.\n* Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.'}, 'identificationModule': {'nctId': 'NCT03789292', 'briefTitle': 'A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'CT-P17 3.1'}, 'secondaryIdInfos': [{'id': '2018-001690-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-P17 Subcutaneous(SC) (adalimumab)', 'description': 'CT-P17 SC (adalimumab)', 'interventionNames': ['Biological: CT-P17 SC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humira SC (adalimumab)', 'description': 'Humira SC (adalimumab)', 'interventionNames': ['Biological: CT-P17 SC', 'Biological: Humira SC']}], 'interventions': [{'name': 'CT-P17 SC', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous injection of Adalimumab 40mg every two weeks', 'armGroupLabels': ['CT-P17 Subcutaneous(SC) (adalimumab)', 'Humira SC (adalimumab)']}, {'name': 'Humira SC', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous injection of Adalimumab 40mg every two weeks', 'armGroupLabels': ['Humira SC (adalimumab)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'National Multiprofile Transport Hospital Tsar Boris III', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'overallOfficials': [{'name': 'MinJi Ma', 'role': 'STUDY_CHAIR', 'affiliation': 'Celltrion, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltrion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}