Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT01545050
Status:
TERMINATED
Last Update Posted:
2021-12-03
First Post:
2012-03-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Brazil', 'Russia', 'Singapore']}, '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': 'C000604955', 'term': 'clazakizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cslbehring.com', 'phone': '610-878-4000', 'title': 'Study Director', 'organization': 'CSL behring'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The interpretation of the PK analysis is limited for several reasons. First, the concentration data that was collected only allowed for reporting of Cmin concentrations. Second, the sample size was limited.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 weeks per participant', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nail dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin depigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Monocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Protein total decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': "Cronh's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorectal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal fistula infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG002', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG003', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day'}, {'id': 'OG004', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '18.8', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 8 weeks during the Induction Period', 'description': 'CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat (mITT) defined as all randomized and treated subjects who had a chance to reach Day 57 by the date of study termination'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG002', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG003', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day'}, {'id': 'OG004', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day'}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '31.3', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 8 weeks during the Induction Period', 'description': 'CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG002', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG003', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day'}, {'id': 'OG004', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '23.01', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '28.93', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '36.46', 'groupId': 'OG002'}, {'value': '15.5', 'spread': '32.01', 'groupId': 'OG003'}, {'value': '14.8', 'spread': '33.7', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '33.65', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '34.62', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '61.06', 'groupId': 'OG002'}, {'value': '20.1', 'spread': '36.32', 'groupId': 'OG003'}, {'value': '18.7', 'spread': '35.62', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8 and Week 12', 'description': 'IBDQ consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants During the Induction Period With Anti-clazakizumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG002', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG003', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day'}, {'id': 'OG004', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG001', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG002', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day'}, {'id': 'OG003', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.0816', 'spread': '8.19326', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.1026', 'spread': '14.49349', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 8', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, only a limited number of PK samples were collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG001', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG002', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day'}, {'id': 'OG003', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day'}], 'timeFrame': 'Week 0 and Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'The interpretation of the PK analysis is limited for several reasons. First, the concentration data that was collected only allowed for reporting of Cmin concentrations. Second, the sample size was limited.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG001', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'OG002', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day'}, {'id': 'OG003', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day'}], 'timeFrame': 'Week 0, Week 4, Week 8', 'reportingStatus': 'POSTED', 'populationDescription': 'The interpretation of the PK analysis is limited for several reasons. First, the concentration data that was collected only allowed for reporting of Cmin concentrations. Second, the sample size was limited.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks'}, {'id': 'FG001', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'FG002', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'FG003', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day'}, {'id': 'FG004', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Discontinued study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks'}, {'id': 'BG001', 'title': 'Clazakizumab (150 IV/100 SC)', 'description': 'IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'BG002', 'title': 'Clazakizumab (300 IV/100 SC)', 'description': 'IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day'}, {'id': 'BG003', 'title': 'Clazakizumab (400 SC/200 SC)', 'description': 'SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day'}, {'id': 'BG004', 'title': 'Clazakizumab (600 IV/200 SC)', 'description': 'IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '69', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '11.70', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '14.79', 'groupId': 'BG001'}, {'value': '36.2', 'spread': '17.29', 'groupId': 'BG002'}, {'value': '36.3', 'spread': '10.96', 'groupId': 'BG003'}, {'value': '40.9', 'spread': '11.48', 'groupId': 'BG004'}, {'value': '38.6', 'spread': '12.53', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'whyStopped': 'due to sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2015-07-24', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-06', 'studyFirstSubmitDate': '2012-03-01', 'dispFirstSubmitQcDate': '2015-07-24', 'resultsFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2012-03-05', 'dispFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-06', 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)", 'timeFrame': 'At 8 weeks during the Induction Period', 'description': 'CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI', 'timeFrame': 'At 8 weeks during the Induction Period', 'description': 'CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity'}, {'measure': 'Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score', 'timeFrame': 'Week 8 and Week 12', 'description': 'IBDQ consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.'}, {'measure': 'Number of Participants During the Induction Period With Anti-clazakizumab Antibodies', 'timeFrame': 'Up to Week 12'}, {'measure': 'Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period', 'timeFrame': 'Week 4, Week 8'}, {'measure': 'Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period', 'timeFrame': 'Week 0 and Week 4'}, {'measure': 'Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period', 'timeFrame': 'Week 0, Week 4, Week 8'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior 12 months. Diagnosed for at least 3 months\n* Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450\n* Failed conventional therapy or steroid dependent\n\nExclusion Criteria:\n\n* Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non colonic/ileal disease\n* Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis\n* History of diverticulitis, or evidence of Gastrointestinal (GI) perforations"}, 'identificationModule': {'nctId': 'NCT01545050', 'briefTitle': "Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': "A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease", 'orgStudyIdInfo': {'id': 'IM133-005'}, 'secondaryIdInfos': [{'id': '2011-004763-72', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab)', 'interventionNames': ['Biological: Placebo matching with BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)', 'interventionNames': ['Biological: Placebo matching with BMS-945429', 'Biological: BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)', 'interventionNames': ['Biological: Placebo matching with BMS-945429', 'Biological: BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)', 'interventionNames': ['Biological: Placebo matching with BMS-945429', 'Biological: BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)', 'interventionNames': ['Biological: Placebo matching with BMS-945429', 'Biological: BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance Cohort: Placebo matching with BMS-945429 (Clazakizumab)', 'interventionNames': ['Biological: Placebo matching with BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance Cohort: BMS-945429 (Clazakizumab)(100 SC mg)', 'interventionNames': ['Biological: BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance Cohort: BMS-945429 (Clazakizumab)(200 SC mg)', 'interventionNames': ['Biological: BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg)', 'interventionNames': ['Biological: BMS-945429']}], 'interventions': [{'name': 'Placebo matching with BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Intravenous (IV), 0 mg, Day One Only, One Day', 'armGroupLabels': ['Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)', 'Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab)']}, {'name': 'Placebo matching with BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks', 'armGroupLabels': ['Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab)']}, {'name': 'Placebo matching with BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day', 'armGroupLabels': ['Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)', 'Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)', 'Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)']}, {'name': 'Placebo matching with BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks', 'armGroupLabels': ['Maintenance Cohort: Placebo matching with BMS-945429 (Clazakizumab)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'otherNames': ['Clazakizumab'], 'description': 'Injection, Intravenous (IV), 600 mg, Day One Only, One Day', 'armGroupLabels': ['Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'otherNames': ['Clazakizumab'], 'description': 'Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day', 'armGroupLabels': ['Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)', 'Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'otherNames': ['Clazakizumab'], 'description': 'Injection, Intravenous (IV), 300 mg, Day One Only, One Day', 'armGroupLabels': ['Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'otherNames': ['Clazakizumab'], 'description': 'Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day', 'armGroupLabels': ['Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)', 'Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'otherNames': ['Clazakizumab'], 'description': 'Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks', 'armGroupLabels': ['Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'otherNames': ['Clazakizumab'], 'description': 'Injection, Intravenous (IV), 150 mg, Day One Only, One Day', 'armGroupLabels': ['Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'otherNames': ['Clazakizumab'], 'description': 'Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks', 'armGroupLabels': ['Maintenance Cohort: BMS-945429 (Clazakizumab)(100 SC mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'otherNames': ['Clazakizumab'], 'description': 'Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks', 'armGroupLabels': ['Maintenance Cohort: BMS-945429 (Clazakizumab)(200 SC mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'otherNames': ['Clazakizumab'], 'description': 'Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period', 'armGroupLabels': ['Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University Of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92114', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Precision Research Institute, Llc', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'South Denver Gastroenterology, Pc', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University Of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University Of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Premier Medical Group Of The Hudson Valley, Pc', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Options Health Research, Llc', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Gastro One', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V6Z 2K5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '50012', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '40237', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '60431', 'city': 'Frankfurt A. M', 'country': 'Germany', 'facility': 'Local Institution'}, {'zip': '44623', 'city': 'Herne', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '48155', 'city': 'Münster', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Local Institution', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '1136', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4025', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '7623', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Local Institution', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '500082', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Local Institution'}, {'zip': '400020', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '141001', 'city': 'Ludhiana', 'country': 'India', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'zip': '400 029', 'city': 'Mumbai', 'country': 'India', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '411030', 'city': 'Pune', 'country': 'India', 'facility': 'Local Institution', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '00152', 'city': 'Roma', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '20097', 'city': 'San Donato Milanese (mi)', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '71013', 'city': 'San Giovanni Rotondo (fg)', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '31-864', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '90-302', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '50-556', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '53-114', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '80756', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Local Institution', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'state': 'Kingston Upon Hull, City of', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'HA1 2UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}