Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT00094458
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2004-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D001379', 'term': 'Azathioprine'}, {'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '215 325-7405', 'title': 'Study Director', 'organization': 'Centocor Ortho Biotech Services, L.L.C.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '1 patient in AZA+PBO group(gp),3 in IFX+PBO gp,1 in IFX+AZA gp were randomized but not treated(Excluded from safety analyses).Safety population for IFX+AZA gp included 11 patients assigned to one of monotherapy gps but inadvertently were given at least one dose of both active oral and intravenous therapy(8 patients in AZA+PBO gp,3 in IFX+PBO gp).', 'eventGroups': [{'id': 'EG000', 'title': 'W30-Azathioprine + Placebo', 'description': 'Azathioprine (AZA) oral capsules 2.5 mg/kg/day and Placebo (PBO) infusion through Week 30.', 'otherNumAtRisk': 161, 'otherNumAffected': 120, 'seriousNumAtRisk': 161, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'W30-Infliximab + Placebo', 'description': 'Placebo (PBO) oral daily and Infliximab (IFX) infusions 5 mg/kg through Week 30.', 'otherNumAtRisk': 163, 'otherNumAffected': 122, 'seriousNumAtRisk': 163, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'W30-Infliximab + Azathioprine', 'description': 'Azathioprine (AZA) oral daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5mg/kg through Week 30.', 'otherNumAtRisk': 179, 'otherNumAffected': 133, 'seriousNumAtRisk': 179, 'seriousNumAffected': 25}, {'id': 'EG003', 'title': 'W50-Azathioprine + Placebo', 'description': '(AZA) oral daily 2.5 mg/kg/day and Placebo (PBO) infusion Week 30 through Week 50.', 'otherNumAtRisk': 75, 'otherNumAffected': 44, 'seriousNumAtRisk': 75, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'W50-Infliximab + Placebo', 'description': 'Placebo (PBO) oral capsules daily and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.', 'otherNumAtRisk': 97, 'otherNumAffected': 69, 'seriousNumAtRisk': 97, 'seriousNumAffected': 15}, {'id': 'EG005', 'title': 'W50-Infliximab + Azathioprine', 'description': 'Azathioprine (AZA) oral capsules daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.', 'otherNumAtRisk': 108, 'otherNumAffected': 61, 'seriousNumAtRisk': 108, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'OLE-Azathioprine + Placebo/Infliximab', 'description': 'Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and Placebo (PBO) infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'OLE-Infliximab + Placebo/Infliximab', 'description': 'Placebo (PBO) oral capsules daily and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.', 'otherNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'OLE-Infliximab + Azathioprine/Infliximab', 'description': 'Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.', 'otherNumAtRisk': 17, 'otherNumAffected': 15, 'seriousNumAtRisk': 17, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Amaurosis Fugax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eyelids Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Panophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aphthous Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 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17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Female Genital Tract Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyshidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Miscarriage of Partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Corticosteriod-free Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}, {'value': '56.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline", 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline", 'testedNonInferiority': False}, {'pValue': '0.022', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': "Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (\\<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (\\>=) 3 weeks and have not received budesonide at a dose \\> 6 milligram per day (mg/day) for \\>= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population includes all randomized participants in the analysis, according to the treatment group to which they were randomized, regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mucosal Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000'}, {'value': '30.1', 'groupId': 'OG001'}, {'value': '43.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline", 'testedNonInferiority': False}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline", 'testedNonInferiority': False}, {'pValue': '0.055', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population for mucosal healing was per protocol. All subjects with lesions at Baseline (Week 0) and an Endoscopy at Week 26 were included in the analysis. Here, 'N' \\[number of participants analyzed\\] signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '60.8', 'groupId': 'OG001'}, {'value': '72.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 50', 'description': "Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) \\< 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for \\>= 3 weeks and have not received budesonide at a dose \\> 6 milligram per day (mg/day) for \\>= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed included all randomized participants enrolled in Study Extension.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Remission (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}, {'value': '36.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}, {'value': '49.1', 'groupId': 'OG001'}, {'value': '52.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '47.3', 'groupId': 'OG001'}, {'value': '59.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000'}, {'value': '49.7', 'groupId': 'OG001'}, {'value': '60.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000'}, {'value': '47.9', 'groupId': 'OG001'}, {'value': '60.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 6, 10, 18 and 26', 'description': 'Clinical remission is defined as a CDAI \\< 150, compared to baseline (Week 0)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed included all randomized participants enrolled in the main study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Remission (Study Extension)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}], 'classes': [{'title': 'Week 34', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}, {'value': '66.0', 'groupId': 'OG001'}, {'value': '69.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 42', 'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000'}, {'value': '72.2', 'groupId': 'OG001'}, {'value': '73.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 50', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '66.0', 'groupId': 'OG001'}, {'value': '74.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 34, 42 and 50', 'description': 'Clinical remission is defined as a CDAI \\< 150, compared to baseline (Week 0)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed included all randomized participants enrolled in the Study Extension.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response Over Time (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}, {'value': '47.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000'}, {'value': '54.4', 'groupId': 'OG001'}, {'value': '63.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}, {'value': '55.0', 'groupId': 'OG001'}, {'value': '62.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000'}, {'value': '54.4', 'groupId': 'OG001'}, {'value': '62.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 6, 10, 18, 26', 'description': 'Clinical response, defined as a \\>=100-point decrease in CDAI from Baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed included all randomized participants during the Main Study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response Over Time (Study Extension)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}], 'classes': [{'title': 'Week 34', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '76.3', 'groupId': 'OG001'}, {'value': '76.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 42', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}, {'value': '77.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 50', 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000'}, {'value': '72.2', 'groupId': 'OG001'}, {'value': '78.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 34, 42, 50', 'description': 'Clinical response, defined as a \\>=100-point decrease in CDAI from Baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed included all randomized participants during the Study Extension.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}], 'classes': [{'title': 'Week 2 (n= 160, 160, 163)', 'categories': [{'measurements': [{'value': '20.1', 'spread': '24.29', 'groupId': 'OG000'}, {'value': '27.7', 'spread': '26.08', 'groupId': 'OG001'}, {'value': '31.4', 'spread': '29.60', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 (n= 162, 161, 165)', 'categories': [{'measurements': [{'value': '28.3', 'spread': '31.25', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '31.79', 'groupId': 'OG001'}, {'value': '39.9', 'spread': '32.90', 'groupId': 'OG002'}]}]}, {'title': 'Week 10 (n= 162, 161, 165)', 'categories': [{'measurements': [{'value': '31.0', 'spread': '31.66', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '35.56', 'groupId': 'OG001'}, {'value': '42.4', 'spread': '34.67', 'groupId': 'OG002'}]}]}, {'title': 'Week 18 (n= 162, 161, 165)', 'categories': [{'measurements': [{'value': '30.3', 'spread': '33.92', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '34.17', 'groupId': 'OG001'}, {'value': '43.7', 'spread': '34.56', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (n= 162, 161, 165)', 'categories': [{'measurements': [{'value': '31.4', 'spread': '35.43', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '36.62', 'groupId': 'OG001'}, {'value': '45.2', 'spread': '35.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 2, 6, 10, 18, 26', 'description': 'Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Population analyzed included all randomized participants enrolled in Main Study with last observation carried forward method to impute missing data. 'n' signifies number of participants who were evaluable at specified time point, for each arm respectively."}, {'type': 'SECONDARY', 'title': 'Average Corticosteroid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'OG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}], 'classes': [{'title': 'Week 2 (n=48, 50, 49)', 'categories': [{'measurements': [{'value': '22.92', 'spread': '12.476', 'groupId': 'OG000'}, {'value': '21.20', 'spread': '11.883', 'groupId': 'OG001'}, {'value': '22.75', 'spread': '11.923', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 (n=53, 52, 51)', 'categories': [{'measurements': [{'value': '18.56', 'spread': '11.588', 'groupId': 'OG000'}, {'value': '17.68', 'spread': '10.993', 'groupId': 'OG001'}, {'value': '18.26', 'spread': '11.635', 'groupId': 'OG002'}]}]}, {'title': 'Week 10 (n=56, 56, 52)', 'categories': [{'measurements': [{'value': '16.19', 'spread': '11.160', 'groupId': 'OG000'}, {'value': '15.68', 'spread': '14.924', 'groupId': 'OG001'}, {'value': '15.01', 'spread': '11.087', 'groupId': 'OG002'}]}]}, {'title': 'Week 18 (n=59, 57, 56)', 'categories': [{'measurements': [{'value': '13.49', 'spread': '10.929', 'groupId': 'OG000'}, {'value': '13.23', 'spread': '17.206', 'groupId': 'OG001'}, {'value': '11.64', 'spread': '10.904', 'groupId': 'OG002'}]}]}, {'title': 'Week 26 (n=60, 60, 58)', 'categories': [{'measurements': [{'value': '11.57', 'spread': '10.246', 'groupId': 'OG000'}, {'value': '10.96', 'spread': '15.990', 'groupId': 'OG001'}, {'value': '9.35', 'spread': '10.052', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 6, 10, 18 and 26', 'description': 'Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)', 'unitOfMeasure': 'milligram per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Population analyzed included all randomized participants taking corticosteroids for Crohn's disease. n' signifies number of participants who were evaluable at specified time point, for each arm respectively."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'FG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'FG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'FG003', 'title': 'Azathioprine + Placebo/Infliximab', 'description': 'Participants received daily AZA oral capsules 2.5mg/kg/day and Placebo infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (EU and Israel) open-Label Extension.'}, {'id': 'FG004', 'title': 'Infliximab + Placebo/Infliximab', 'description': 'Participants received Placebo oral capsules daily and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.'}, {'id': 'FG005', 'title': 'Infliximab + Azathioprine/Infliximab', 'description': 'Participants received daily AZA oral capsules 2.5mg/kg/day and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.'}], 'periods': [{'title': 'Main Study: Through Week 30', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '169'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '121'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Eligibility criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Study Extension: Week 30 Through Week 50', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '108'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'OLE: Open-Label Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Inadequate therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '508', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Azathioprine + Placebo', 'description': 'Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'BG001', 'title': 'Infliximab + Placebo', 'description': 'Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'BG002', 'title': 'Infliximab + Azathioprine', 'description': 'Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '12.92', 'groupId': 'BG000'}, {'value': '36.6', 'spread': '13', 'groupId': 'BG001'}, {'value': '35.9', 'spread': '11.97', 'groupId': 'BG002'}, {'value': '36.3', 'spread': '12.62', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '262', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'AUSTRIA', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'DENMARK', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'GREECE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'ISRAEL', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'NETHERLANDS', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'NORWAY', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'PORTUGAL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'UK', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'USA', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 508}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2004-10-19', 'resultsFirstSubmitDate': '2009-04-30', 'studyFirstSubmitQcDate': '2004-10-19', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-04', 'studyFirstPostDateStruct': {'date': '2004-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Corticosteriod-free Clinical Remission', 'timeFrame': 'Week 26', 'description': "Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (\\<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (\\>=) 3 weeks and have not received budesonide at a dose \\> 6 milligram per day (mg/day) for \\>= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse)."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Mucosal Healing', 'timeFrame': 'Week 26', 'description': 'Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.'}, {'measure': 'Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)', 'timeFrame': 'Week 50', 'description': "Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) \\< 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for \\>= 3 weeks and have not received budesonide at a dose \\> 6 milligram per day (mg/day) for \\>= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse)."}, {'measure': 'Percentage of Participants With Clinical Remission (Main Study)', 'timeFrame': 'Weeks 2, 6, 10, 18 and 26', 'description': 'Clinical remission is defined as a CDAI \\< 150, compared to baseline (Week 0)'}, {'measure': 'Percentage of Participants With Clinical Remission (Study Extension)', 'timeFrame': 'Weeks 34, 42 and 50', 'description': 'Clinical remission is defined as a CDAI \\< 150, compared to baseline (Week 0)'}, {'measure': 'Percentage of Participants With Clinical Response Over Time (Main Study)', 'timeFrame': 'Weeks 2, 6, 10, 18, 26', 'description': 'Clinical response, defined as a \\>=100-point decrease in CDAI from Baseline.'}, {'measure': 'Percentage of Participants With Clinical Response Over Time (Study Extension)', 'timeFrame': 'Weeks 34, 42, 50', 'description': 'Clinical response, defined as a \\>=100-point decrease in CDAI from Baseline.'}, {'measure': 'Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)', 'timeFrame': 'Baseline and Weeks 2, 6, 10, 18, 26', 'description': 'Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).'}, {'measure': 'Average Corticosteroid Use', 'timeFrame': 'Weeks 2, 6, 10, 18 and 26', 'description': 'Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's Disease", 'infliximab', 'azathioprine', 'Remicade', 'SONIC'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '20393175', 'type': 'RESULT', 'citation': "Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492."}, {'pmid': '34216825', 'type': 'DERIVED', 'citation': "Dulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30."}, {'pmid': '30267864', 'type': 'DERIVED', 'citation': "Colombel JF, Adedokun OJ, Gasink C, Gao LL, Cornillie FJ, D'Haens GR, Rutgeerts PJ, Reinisch W, Sandborn WJ, Hanauer SB. Combination Therapy With Infliximab and Azathioprine Improves Infliximab Pharmacokinetic Features and Efficacy: A Post Hoc Analysis. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1525-1532.e1. doi: 10.1016/j.cgh.2018.09.033. Epub 2018 Sep 26."}, {'pmid': '25728587', 'type': 'DERIVED', 'citation': "Colombel JF, Reinisch W, Mantzaris GJ, Kornbluth A, Rutgeerts P, Tang KL, Oortwijn A, Bevelander GS, Cornillie FJ, Sandborn WJ. Randomised clinical trial: deep remission in biologic and immunomodulator naive patients with Crohn's disease - a SONIC post hoc analysis. Aliment Pharmacol Ther. 2015 Apr;41(8):734-46. doi: 10.1111/apt.13139. Epub 2015 Mar 1."}, {'pmid': '25245629', 'type': 'DERIVED', 'citation': "Reinisch W, Colombel JF, Sandborn WJ, Mantzaris GJ, Kornbluth A, Adedokun OJ, Miller M, Tang KL, Rutgeerts P, Cornillie F. Factors associated with short- and long-term outcomes of therapy for Crohn's disease. Clin Gastroenterol Hepatol. 2015 Mar;13(3):539-547.e2. doi: 10.1016/j.cgh.2014.09.031. Epub 2014 Sep 19."}, {'pmid': '23974954', 'type': 'DERIVED', 'citation': "Peyrin-Biroulet L, Reinisch W, Colombel JF, Mantzaris GJ, Kornbluth A, Diamond R, Rutgeerts P, Tang LK, Cornillie FJ, Sandborn WJ. Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn's disease in the SONIC trial. Gut. 2014 Jan;63(1):88-95. doi: 10.1136/gutjnl-2013-304984. Epub 2013 Aug 23."}, {'pmid': '23954314', 'type': 'DERIVED', 'citation': "Ferrante M, Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens GR, van der Woude CJ, Danese S, Diamond RH, Oortwijn AF, Tang KL, Miller M, Cornillie F, Rutgeerts PJ; International Organization for the Study of Inflammatory Bowel Diseases. Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC. Gastroenterology. 2013 Nov;145(5):978-986.e5. doi: 10.1053/j.gastro.2013.08.010. Epub 2013 Aug 14."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.", 'detailedDescription': 'Crohns disease is characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (open sores) of the intestines. Crohns disease is treated with medications that decrease inflammation, and reduce diarrhea, abdominal pain and other symptoms of Crohns disease. In addition, Crohns disease can be treated with medications that suppress the immune system (the body system involved in inflammation and infections) or with surgery. This study will investigate the effectiveness of infliximab and azathioprine in the treatment of patients with moderate-to-severe Crohns disease. Infliximab is currently approved by the FDA for the treatment of both Crohns disease and rheumatoid arthritis. Azathioprine, which is an investigational drug, has not been approved by the FDA for the treatment of Crohns disease, but it is a well-established therapy that has been used for many years to treat Crohns disease. This study seeks to determine whether infliximab, azathioprine, or the combination of both drugs would be the most appropriate treatment for Crohns disease patients who have not responded well to certain drugs called 5-ASA drugs (e.g. Asacol, Pentasa, sulfasalazine) and/or require frequent treatment with corticosteroids. This research study will involve approximately 500 patients. Patients may participate in the main study for up to 34 weeks (approximately 8 months). During the main study, patients will be asked to visit the study center for 10 visits. If patients enroll into the extension of the study, the total time for participation may be up to 54 weeks (approximately 13 months). Patients enrolled in the Study Extension will be asked to visit the study center for an additional 5 visits. A country-specific (EU and Israel only), prospective, multi-center, open-label extension of the study will further evaluate the long-term safety and efficacy of scheduled maintenance therapy with infliximab in patients with Crohns Disease. Patients who have completed treatment through Week 50 in the SONIC main study and who, in the opinion of the investigator, would benefit from infliximab treatment may enter the open-label extension. Patients will be randomly assigned to one of three treatment groups (either infliximab plus placebo capsules, infliximab plus azathioprine, or azathioprine plus placebo infusions - there is no possibility of being assigned to placebo only in this trial - patients will receive one or both of these medications) at the beginning of the study. Oral medication will be taken daily. There are 5 infusion (which will be either infliximab or placebo) visits during the main study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Crohns Disease for at least 6 weeks\n* Moderate to severe disease activity (CDAI \\>= 220 and \\<=450)\n* No history of azathioprine, 6-MP (6 Mercaptopurine), or biologic treatments\n* Are either: Corticosteriod-dependent, OR considered for a 2nd (or greater) course of corticosteriod, OR 5-ASA failures, Or Budesonide failures\n\nExclusion Criteria:\n\n* History of abdominal surgery within the last 6 months\n* Have an ostomy or stoma \\[An operation to create an opening from an area inside the body to the outside\\]\n* Are pregnant, nursing, or planning pregnancy (both men and women)\n* Serious simultaneous illness that could interfere with study participation\n* Use of any investigational drug within 30 days\n* Have a concomitant diagnosis or any history of congestive heart failure\n* Weigh more than 140 kilograms (or 310 pounds)'}, 'identificationModule': {'nctId': 'NCT00094458', 'briefTitle': "Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC", 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor Ortho Biotech Services, L.L.C.'}, 'officialTitle': "Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy", 'orgStudyIdInfo': {'id': 'CR004804'}, 'secondaryIdInfos': [{'id': 'C0168T67'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '003', 'description': 'infliximab (IFX) infusion; azathioprine (AZA) caps AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22', 'interventionNames': ['Other: infliximab (IFX) infusion; azathioprine (AZA) caps']}, {'type': 'EXPERIMENTAL', 'label': '001', 'description': 'infliximab (IFX) placebo infusion; azathioprine (AZA) caps AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22', 'interventionNames': ['Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps']}, {'type': 'EXPERIMENTAL', 'label': '002', 'description': 'infliximab infusion; AZA placebo caps Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules', 'interventionNames': ['Biological: infliximab infusion; AZA placebo caps']}], 'interventions': [{'name': 'infliximab infusion; AZA placebo caps', 'type': 'BIOLOGICAL', 'description': 'Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules', 'armGroupLabels': ['002']}, {'name': 'infliximab (IFX) infusion; azathioprine (AZA) caps', 'type': 'OTHER', 'description': 'AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22', 'armGroupLabels': ['003']}, {'name': 'infliximab (IFX) placebo infusion; azathioprine (AZA) caps', 'type': 'DRUG', 'description': 'AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Roseville', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 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