Viewing Study NCT02557295

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Ignite Creation Date: 2025-12-24 @ 2:15 PM
Ignite Modification Date: 2026-02-27 @ 6:49 AM
Study NCT ID: NCT02557295
Status: TERMINATED
Last Update Posted: 2024-11-26
First Post: 2015-03-18
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, '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': '82-32-850-5702', 'title': 'JiWoong Lim', 'organization': 'Celltrion Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of study participation (up to 5 years)', 'description': 'The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.', 'eventGroups': [{'id': 'EG000', 'title': 'Remsima', 'description': 'Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 56, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Switch to Remsima I', 'description': 'Patients who switched from Remicade to Remsima were included in this analysis group.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Switch to Remsima II', 'description': 'Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 7, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Remicade', 'description': 'Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Switch to Remicade I', 'description': 'Patients who switched from Remsima to Remicade were included in this analysis group.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Switch to Remicade II', 'description': 'Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Other Anti-TNF', 'description': 'Following patients were included in other anti-TNF group.\n\n* Patients who have received only anti-TNF other than Remsima or Remicade\n* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade\n* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 39, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG007', 'title': 'Switch to Other Anti-TNF', 'description': 'Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Biologic Naïve', 'description': 'Patients who received only non-biologic treatment will be included in this analysis group.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 13, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oesophageal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Latent Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinea Pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 12}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic Enzyme Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal Column Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lactation Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticarial vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '81', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Remsima', 'description': 'Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.'}, {'id': 'OG001', 'title': 'Switch to Remsima I', 'description': 'Patients who switched from Remicade to Remsima were included in this analysis group.'}, {'id': 'OG002', 'title': 'Switch to Remsima II', 'description': 'Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.'}, {'id': 'OG003', 'title': 'Remicade', 'description': 'Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.'}, {'id': 'OG004', 'title': 'Switch to Remicade I', 'description': 'Patients who switched from Remsima to Remicade were included in this analysis group.'}, {'id': 'OG005', 'title': 'Switch to Remicade II', 'description': 'Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.'}, {'id': 'OG006', 'title': 'Other Anti-TNF', 'description': 'Following patients were included in other anti-TNF group.\n\n* Patients who have received only anti-TNF other than Remsima or Remicade\n* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade\n* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade'}, {'id': 'OG007', 'title': 'Switch to Other Anti-TNF', 'description': 'Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.'}, {'id': 'OG008', 'title': 'Biologic Naïve', 'description': 'Patients who received only non-biologic treatment will be included in this analysis group.'}], 'classes': [{'title': 'TEAE of Serious infections including sepsis (excluding opportunistic infections and tuberculosis)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'TEAE of tuberculosis', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'TEAE of Haematological reactions', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'TEAE of Systemic lupus erythematosus/lupus-like syndrom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'TEAE of Hepatobiliary events', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'TEAE of Malignancies (excluding lymphoma)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'TEAE of Infusion reactions associated with shortened infusion duration', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'TEAE of Infusion related reaction/hypersensitivity/ anaphylactic reaction', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of study participation (up to 5 years)', 'description': '* Hepatitis B virus reactivation\n* Congestive heart failure\n* Opportunistic infections (excluding tuberculosis)\n* Serious infections including sepsis (excluding opportunistic infections and tuberculosis)\n* Tuberculosis (TB)\n* Serum sickness (delayed hypersensitivity reactions)\n* Haematological reactions\n* Systemic lupus erythematosus/lupus-like syndrome\n* Demyelinating disorders\n* Lymphoma (not hepatosplenic T cell lymphoma)\n* Hepatobiliary events\n* Hepatosplenic T cell lymphoma (HSTCL)\n* Serious infusion reactions during a re-induction regimen following disease flare\n* Sarcoidosis/sarcoid-like reactions\n* Leukaemia\n* Malignancy (excluding lymphoma)\n* Skin cancer\n* Pregnancy exposure\n* Infusion reactions associated with shortened infusion duration\n* Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used. All patients data were analyzed; however, there were 0 patients recruited in the "Switch to Remicade I" and "Switch to Remicade II" groups.'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Remsima', 'description': 'Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.'}, {'id': 'OG001', 'title': 'Switch to Remsima', 'description': 'Patients who switched from Remicade to Remsima were included in this analysis group.'}, {'id': 'OG002', 'title': 'Remicade', 'description': 'Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.'}, {'id': 'OG003', 'title': 'Switch to Remicade', 'description': 'Patients who switched from Remsima to Remicade were included in this analysis group.'}], 'classes': [{'title': 'Day 0 DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.698', 'spread': '1.1035', 'groupId': 'OG000'}, {'value': '4.212', 'spread': '1.6056', 'groupId': 'OG001'}, {'value': '5.195', 'spread': '0.8118', 'groupId': 'OG002'}]}]}, {'title': 'Week 30 DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.575', 'spread': '1.4181', 'groupId': 'OG000'}, {'value': '3.833', 'spread': '1.5004', 'groupId': 'OG001'}, {'value': '3.509', 'spread': '2.2685', 'groupId': 'OG002'}]}]}, {'title': 'Week 54 DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.574', 'spread': '1.3803', 'groupId': 'OG000'}, {'value': '3.877', 'spread': '1.3921', 'groupId': 'OG001'}, {'value': '1.456', 'groupId': 'OG002'}]}]}, {'title': 'Week 78 DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.028', 'spread': '1.2306', 'groupId': 'OG000'}, {'value': '1.282', 'groupId': 'OG002'}]}]}, {'title': 'Week 102 DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.780', 'spread': '0.7859', 'groupId': 'OG000'}]}]}, {'title': 'Week 126 DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.573', 'spread': '0.6413', 'groupId': 'OG000'}]}]}, {'title': 'Week 150 DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.300', 'groupId': 'OG000'}]}]}, {'title': 'Week 174 DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.090', 'groupId': 'OG000'}]}]}, {'title': 'Week 198 DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.100', 'groupId': 'OG000'}]}]}, {'title': 'Day 0 DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.016', 'spread': '1.1541', 'groupId': 'OG000'}, {'value': '3.172', 'spread': '2.0141', 'groupId': 'OG001'}, {'value': '4.763', 'spread': '0.9537', 'groupId': 'OG002'}]}]}, {'title': 'Week 30 DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.969', 'spread': '1.2336', 'groupId': 'OG000'}, {'value': '2.775', 'spread': '1.3919', 'groupId': 'OG001'}, {'value': '3.665', 'spread': '1.7950', 'groupId': 'OG002'}]}]}, {'title': 'Week 54 DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.963', 'spread': '1.3779', 'groupId': 'OG000'}, {'value': '2.854', 'spread': '1.3705', 'groupId': 'OG001'}, {'value': '1.172', 'groupId': 'OG002'}]}]}, {'title': 'Week 78 DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.583', 'spread': '1.0857', 'groupId': 'OG000'}, {'value': '1.219', 'groupId': 'OG002'}]}]}, {'title': 'Week 102 DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.979', 'spread': '0.7980', 'groupId': 'OG000'}]}]}, {'title': 'Week 126 DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.200', 'spread': '0.7632', 'groupId': 'OG000'}]}]}, {'title': 'Week 150 DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.050', 'groupId': 'OG000'}]}]}, {'title': 'Week 174 DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.720', 'groupId': 'OG000'}]}]}, {'title': 'Week 198 DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.680', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 ~ Week 198 (every 6 months ±6 weeks)', 'description': 'Disease activity score in 28 joints (DAS28) will be calculated in two ways using the following two equations: DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln(ESR)) + (0.014 × GH); DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln(CRP + 1)) + (0.014 × GH) + 0.96\n\nWhere:\n\nTJC28 = number of tender joints (0-28): tender joint count (TJC); SJC28 = number of swollen joints (0-28): swollen joint count (SJC); ESR = ESR measurement (mm/h); CRP = CRP measurement (mg/L); GH = Patient Global Assessment of Disease Activity measured on VAS (0 - 100 mm)\n\nDisease activity is indexed as follows, on a 10 point scale, with higher numbers indicating worse disease activity:\n\nRemission: DAS28 \\< 2.6 Low Disease Activity: 2.6 ≤ DAS28 \\< 3.2 Moderate Disease Activity: 3.2 ≤ DAS28 ≤ 5.1 High Disease Activity: 5.1 \\< DAS28', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Remsima', 'description': 'Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.'}, {'id': 'OG001', 'title': 'Switch to Remsima', 'description': 'Patients who switched from Remicade to Remsima were included in this analysis group.'}, {'id': 'OG002', 'title': 'Remicade', 'description': 'Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.'}, {'id': 'OG003', 'title': 'Switch to Remicade', 'description': 'Patients who switched from Remsima to Remicade were included in this analysis group.'}], 'classes': [{'title': 'Day 0 HAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0377', 'spread': '0.64472', 'groupId': 'OG000'}, {'value': '0.5417', 'spread': '0.83229', 'groupId': 'OG001'}, {'value': '1.1875', 'spread': '1.14905', 'groupId': 'OG002'}]}]}, {'title': 'Week 30 HAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6141', 'spread': '0.60167', 'groupId': 'OG000'}, {'value': '0.5000', 'spread': '0.50000', 'groupId': 'OG001'}, {'value': '0.7500', 'spread': '1.08972', 'groupId': 'OG002'}]}]}, {'title': 'Week 54 HAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.7173', 'spread': '0.69955', 'groupId': 'OG000'}, {'value': '0.3333', 'spread': '0.47324', 'groupId': 'OG001'}, {'value': '0.4583', 'spread': '0.59073', 'groupId': 'OG002'}]}]}, {'title': 'Week 78 HAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6813', 'spread': '0.63670', 'groupId': 'OG000'}, {'value': '0.0000', 'groupId': 'OG002'}]}]}, {'title': 'Week 102 HAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6364', 'spread': '0.52278', 'groupId': 'OG000'}]}]}, {'title': 'Week 126 HAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.2917', 'spread': '0.40182', 'groupId': 'OG000'}]}]}, {'title': 'Week 150 HAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1250', 'groupId': 'OG000'}]}]}, {'title': 'Week 174 HAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000'}]}]}, {'title': 'Week 198 HAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6250', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 ~ Week 198 (every 6 months ±6 weeks)', 'description': 'The arthritis-related functional disability will be measured using the disability index of the Health Assessment Questionnaire (HAQ), a validated, self-administered form that assesses functional ability in a number of relevant areas, including the ability to dress, rise from bed, eat, walk, maintain personal hygiene, reach, grip and other activities on a scale ranging from 0 (without any difficulty) to 3 (unable to do). Scores range from 0 to 3, with higher scores indicating worse disability.\n\nThere are 8 categories within the Health Assessment Questionnaire. The answer to each question will be scored as follows: Without any difficulty = 0, With some difficulty = 1, With much difficulty = 2, Unable to do = 3.\n\nDivide the summed category scores (using the adjustment score) by the number of categories answered to obtain the HAQ estimate of physical ability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Remsima', 'description': 'Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.'}, {'id': 'FG001', 'title': 'Switch to Remsima', 'description': 'Patients who switched from Remicade to Remsima were included in this analysis group.'}, {'id': 'FG002', 'title': 'Switch to Remsima II', 'description': 'Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.'}, {'id': 'FG003', 'title': 'Remicade', 'description': 'Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.'}, {'id': 'FG004', 'title': 'Switch to Remicade', 'description': 'Patients who switched from Remsima to Remicade were included in this analysis group.'}, {'id': 'FG005', 'title': 'Switch to Remicade II', 'description': 'Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.'}, {'id': 'FG006', 'title': 'Other Anti-TNF', 'description': 'Following patients were included in other anti-TNF group.\n\n* Patients who have received only anti-TNF other than Remsima or Remicade\n* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade\n* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade'}, {'id': 'FG007', 'title': 'Switch to Other Anti-TNF', 'description': 'Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.'}, {'id': 'FG008', 'title': 'Biologic Naïve', 'description': 'Patients who received only non-biologic treatment will be included in this analysis group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '81'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '81'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '3'}]}, {'type': 'Disease Progression', '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'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Study Close', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '37'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '19'}]}, {'type': 'except for study close', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participant flow was summarized by all analysis groups as prespecified in Statistical Analysis Plan.\n\nAccording to study protocol inclusion criteria, without prior RA medication restrictions, patients who received Remsima, Remicade, Other anti-TNF and biologic naïve were enrolled and switching between were allowed', 'preAssignmentDetails': 'A total of 302 patients were screened, and 248 patients were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '81', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}, {'value': '248', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Remsima', 'description': 'Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.'}, {'id': 'BG001', 'title': 'Switch to Remsima I', 'description': 'Patients who switched from Remicade to Remsima were included in this analysis group.'}, {'id': 'BG002', 'title': 'Switch to Remsima II', 'description': 'Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group'}, {'id': 'BG003', 'title': 'Remicade', 'description': 'Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.'}, {'id': 'BG004', 'title': 'Switch to Remicade I', 'description': 'Patients who switched from Remsima to Remicade were included in this analysis group.'}, {'id': 'BG005', 'title': 'Switch to Remicade II', 'description': 'Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.'}, {'id': 'BG006', 'title': 'Other Anti-TNF', 'description': 'Following patients were included in other anti-TNF group.\n\n* Patients who have received only anti-TNF other than Remsima or Remicade\n* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade\n* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade'}, {'id': 'BG007', 'title': 'Switch to Other Anti-TNF', 'description': 'Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.'}, {'id': 'BG008', 'title': 'Biologic Naïve', 'description': 'Patients who received only non-biologic treatment will be included in this analysis group.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '78'}, {'value': '57.5', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '71'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '67'}, {'value': '53.0', 'groupId': 'BG003', 'lowerLimit': '52', 'upperLimit': '56'}, {'value': '53.0', 'groupId': 'BG006', 'lowerLimit': '22', 'upperLimit': '75'}, {'value': '44', 'groupId': 'BG007', 'lowerLimit': '29', 'upperLimit': '58'}, {'value': '54', 'groupId': 'BG008', 'lowerLimit': '38', 'upperLimit': '78'}, {'value': '54.6', 'groupId': 'BG009', 'lowerLimit': '22', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '22', 'groupId': 'BG008'}, {'value': '198', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '50', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}, {'value': '226', 'groupId': 'BG009'}]}, {'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': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '22', 'groupId': 'BG009'}]}, {'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': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All patients data were analyzed; however, there were 0 patients recruited in the "Switch to Remicade I" and "Switch to Remicade II" groups.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-03', 'size': 1472168, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-23T00:46', 'hasProtocol': True}, {'date': '2020-06-19', 'size': 486191, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-23T00:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2015-03-18', 'resultsFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2015-09-21', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-30', 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)', 'timeFrame': 'Duration of study participation (up to 5 years)', 'description': '* Hepatitis B virus reactivation\n* Congestive heart failure\n* Opportunistic infections (excluding tuberculosis)\n* Serious infections including sepsis (excluding opportunistic infections and tuberculosis)\n* Tuberculosis (TB)\n* Serum sickness (delayed hypersensitivity reactions)\n* Haematological reactions\n* Systemic lupus erythematosus/lupus-like syndrome\n* Demyelinating disorders\n* Lymphoma (not hepatosplenic T cell lymphoma)\n* Hepatobiliary events\n* Hepatosplenic T cell lymphoma (HSTCL)\n* Serious infusion reactions during a re-induction regimen following disease flare\n* Sarcoidosis/sarcoid-like reactions\n* Leukaemia\n* Malignancy (excluding lymphoma)\n* Skin cancer\n* Pregnancy exposure\n* Infusion reactions associated with shortened infusion duration\n* Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction'}], 'secondaryOutcomes': [{'measure': 'Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)', 'timeFrame': 'Day 0 ~ Week 198 (every 6 months ±6 weeks)', 'description': 'Disease activity score in 28 joints (DAS28) will be calculated in two ways using the following two equations: DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln(ESR)) + (0.014 × GH); DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln(CRP + 1)) + (0.014 × GH) + 0.96\n\nWhere:\n\nTJC28 = number of tender joints (0-28): tender joint count (TJC); SJC28 = number of swollen joints (0-28): swollen joint count (SJC); ESR = ESR measurement (mm/h); CRP = CRP measurement (mg/L); GH = Patient Global Assessment of Disease Activity measured on VAS (0 - 100 mm)\n\nDisease activity is indexed as follows, on a 10 point scale, with higher numbers indicating worse disease activity:\n\nRemission: DAS28 \\< 2.6 Low Disease Activity: 2.6 ≤ DAS28 \\< 3.2 Moderate Disease Activity: 3.2 ≤ DAS28 ≤ 5.1 High Disease Activity: 5.1 \\< DAS28'}, {'measure': 'Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability', 'timeFrame': 'Day 0 ~ Week 198 (every 6 months ±6 weeks)', 'description': 'The arthritis-related functional disability will be measured using the disability index of the Health Assessment Questionnaire (HAQ), a validated, self-administered form that assesses functional ability in a number of relevant areas, including the ability to dress, rise from bed, eat, walk, maintain personal hygiene, reach, grip and other activities on a scale ranging from 0 (without any difficulty) to 3 (unable to do). Scores range from 0 to 3, with higher scores indicating worse disability.\n\nThere are 8 categories within the Health Assessment Questionnaire. The answer to each question will be scored as follows: Without any difficulty = 0, With some difficulty = 1, With much difficulty = 2, Unable to do = 3.\n\nDivide the summed category scores (using the adjustment score) by the number of categories answered to obtain the HAQ estimate of physical ability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '34250583', 'type': 'DERIVED', 'citation': 'Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.', 'detailedDescription': 'This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with RA in comparison with patients receiving non-biologic treatmentsor other anti-TNF drugs. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment (3 mg/kg of RemsimaTM by IV infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). For patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of at least 950 male and female patients with Rheumatoid Arthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients\n2. Patients with active RA diagnosed according to the revised 1987 ACR or 2010 ACR/EULAR classification criteria\n\nExclusion Criteria:\n\n1. Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins.\n2. Patients with a current or past history of chronic infection\n3. Patients with moderate or severe heart failure (NYHA class III/IV).'}, 'identificationModule': {'nctId': 'NCT02557295', 'briefTitle': 'An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'CT-P13 4.2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Remsima™', 'description': 'Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.'}, {'label': 'Switch to Remsima I', 'description': 'Patients who switched from Remicade to Remsima were included in this analysis group.'}, {'label': 'Switch to Remsima II', 'description': 'Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.'}, {'label': 'Remicade', 'description': 'Patients who have received only Remicade or switched from non-biologic treatment to Remsima were included in this analysis group.'}, {'label': 'Switch to Remicade I', 'description': 'Patients who switched from Remsima to Remicade were included in this analysis group.'}, {'label': 'Switch to Remicade II', 'description': 'Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.'}, {'label': 'Other Anti-TNF', 'description': 'Following patients were included in other anti-TNF group.\n\n* Patients who have received only anti-TNF other than Remsima or Remicade\n* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade\n* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade'}, {'label': 'Switch to Other Anti-TNF', 'description': 'Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group'}, {'label': 'Biologic Naïve', 'description': 'Patients who received only non-biologic treatment will be included in this analysis group'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Klara Sirova', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltrion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}