Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-21 @ 1:52 AM
Study NCT ID:
NCT00771667
Status:
COMPLETED
Last Update Posted:
2013-04-01
First Post:
2008-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '610-651-6554', 'title': 'Director, Clinical Research', 'organization': 'Janssen Research and Development, US'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Placebo IV group', 'otherNumAtRisk': 132, 'otherNumAffected': 53, 'seriousNumAtRisk': 132, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Ustekinumab 1 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group', 'otherNumAtRisk': 130, 'otherNumAffected': 51, 'seriousNumAtRisk': 130, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Ustekinumab 3 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group', 'otherNumAtRisk': 133, 'otherNumAffected': 50, 'seriousNumAtRisk': 133, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Ustekinumab 6 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group', 'otherNumAtRisk': 131, 'otherNumAffected': 47, 'seriousNumAtRisk': 131, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Placebo IV -> Responder -> Placebo SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\\> Responder at week 6 -\\> Receiving Placebo SC at Week 8 and Week 16', 'otherNumAtRisk': 28, 'otherNumAffected': 18, 'seriousNumAtRisk': 28, 'seriousNumAffected': 8}, {'id': 'EG005', 'title': 'Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\\> Nonresponder at week 6 -\\> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16', 'otherNumAtRisk': 85, 'otherNumAffected': 47, 'seriousNumAtRisk': 85, 'seriousNumAffected': 16}, {'id': 'EG006', 'title': 'Ustekinumab IV -> Responder -> Placebo SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\\> Responder at week 6 -\\> Receiving Placebo SC at Week 8 and Week 16', 'otherNumAtRisk': 73, 'otherNumAffected': 39, 'seriousNumAtRisk': 73, 'seriousNumAffected': 12}, {'id': 'EG007', 'title': 'Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\\> Responder at week 6 -\\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16', 'otherNumAtRisk': 72, 'otherNumAffected': 39, 'seriousNumAtRisk': 72, 'seriousNumAffected': 9}, {'id': 'EG008', 'title': 'Ustekinumab IV -> Nonresponder -> Placebo SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\\> Nonresponder at week 6 -\\> Receiving Placebo SC at Week 8 and Week 16', 'otherNumAtRisk': 110, 'otherNumAffected': 64, 'seriousNumAtRisk': 110, 'seriousNumAffected': 21}, {'id': 'EG009', 'title': 'Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\\> Nonresponder at week 6 -\\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16', 'otherNumAtRisk': 109, 'otherNumAffected': 52, 'seriousNumAtRisk': 109, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 16}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 19}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}, 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'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 12}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 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[{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Conversion disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Psychiatric decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Somatoform disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute febrile neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Response at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Placebo IV group'}, {'id': 'OG001', 'title': 'Ustekinumab 1 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group'}, {'id': 'OG002', 'title': 'Ustekinumab 3 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group'}, {'id': 'OG003', 'title': 'Ustekinumab 6 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '0.057', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 6', 'description': "As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \\< 150 was attained.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, regardless of whether they received study agent.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Remission at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Placebo IV group'}, {'id': 'OG001', 'title': 'Ustekinumab 1 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group'}, {'id': 'OG002', 'title': 'Ustekinumab 3 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group'}, {'id': 'OG003', 'title': 'Ustekinumab 6 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.682', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '0.206', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 6', 'description': 'As measured by a CDAI score of \\< 150 points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, regardless of whether they received study agent.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Placebo IV group'}, {'id': 'OG001', 'title': 'Ustekinumab 1 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group'}, {'id': 'OG002', 'title': 'Ustekinumab 3 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group'}, {'id': 'OG003', 'title': 'Ustekinumab 6 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 4', 'description': 'As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \\< 150 was attained.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, regardless of whether they received study agent.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Placebo IV group'}, {'id': 'OG001', 'title': 'Ustekinumab 1 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group'}, {'id': 'OG002', 'title': 'Ustekinumab 3 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group'}, {'id': 'OG003', 'title': 'Ustekinumab 6 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \\< 150 was attained.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, regardless of whether they received study agent.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Placebo IV group'}, {'id': 'OG001', 'title': 'Ustekinumab 1 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group'}, {'id': 'OG002', 'title': 'Ustekinumab 3 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group'}, {'id': 'OG003', 'title': 'Ustekinumab 6 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '0.081', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for anti-TNF status.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'As measured by a CDAI score of \\< 150 points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, regardless of whether they received study agent.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'As a single subcutaneous dose at Weeks 8 and 16'}, {'id': 'OG001', 'title': 'Ustekinumab 90 mg SC', 'description': 'As a single subcutaneous dose at Weeks 8 and 16'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing for Week-22 clinical remission was performed if the comparison of 6-mg/kg ustekinumab with placebo was positive for the primary endpoint.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test chi-square test, stratified by IV induction dose and clinical remission status at Week 6.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 22', 'description': 'As measured by a CDAI score of \\< 150 points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, regardless of whether they received study agent.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'As a single subcutaneous dose at Weeks 8 and 16'}, {'id': 'OG001', 'title': 'Ustekinumab 90 mg SC', 'description': 'As a single subcutaneous dose at Weeks 8 and 16'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The CMH test is controlling for induction dose and clinical remission status at Week 6.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 22', 'description': 'As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \\< 150 was attained.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, regardless of whether they received study agent.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Placebo IV group'}, {'id': 'FG001', 'title': 'Ustekinumab 1 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group'}, {'id': 'FG002', 'title': 'Ustekinumab 3 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group'}, {'id': 'FG003', 'title': 'Ustekinumab 6 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group'}, {'id': 'FG004', 'title': 'Placebo IV -> Responder -> Placebo SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\\> Responder at week 6 -\\> Receiving Placebo SC at Week 8 and Week 16'}, {'id': 'FG005', 'title': 'Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -\\> Nonresponder at week 6 -\\> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16'}, {'id': 'FG006', 'title': 'Ustekinumab IV -> Responder -> Placebo SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\\> Responder at week 6 -\\> Receiving Placebo SC at Week 8 and Week 16'}, {'id': 'FG007', 'title': 'Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\\> Responder at week 6 -\\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16'}, {'id': 'FG008', 'title': 'Ustekinumab IV -> Nonresponder -> Placebo SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\\> Nonresponder at week 6 -\\> Receiving Placebo SC at Week 8 and Week 16'}, {'id': 'FG009', 'title': 'Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -\\> Nonresponder at week 6 -\\> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16'}], 'periods': [{'title': 'Induction Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '132'}, {'groupId': 'FG003', 'numSubjects': '131'}, {'comment': '"0" in column indicates this reporting group is not relevant to Induction period.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Induction period.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Induction period.', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Induction period.', 'groupId': 'FG007', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Induction period.', 'groupId': 'FG008', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Induction period.', 'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '123'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '"0" in column indicates this reporting group is not relevant to Maintenance period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Maintenance period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Maintenance period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Maintenance period.', 'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 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{'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '526', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Placebo IV group'}, {'id': 'BG001', 'title': 'Ustekinumab 1 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group'}, {'id': 'BG002', 'title': 'Ustekinumab 3 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group'}, {'id': 'BG003', 'title': 'Ustekinumab 6 mg/kg (IP)', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '13.05', 'groupId': 'BG000'}, {'value': '38.8', 'spread': '11.95', 'groupId': 'BG001'}, {'value': '38.2', 'spread': '12.63', 'groupId': 'BG002'}, {'value': '39.4', 'spread': '13.21', 'groupId': 'BG003'}, {'value': '39', 'spread': '12.69', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '309', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '217', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 526}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'dispFirstSubmitDate': '2011-04-26', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-26', 'studyFirstSubmitDate': '2008-10-10', 'dispFirstSubmitQcDate': '2011-04-26', 'resultsFirstSubmitDate': '2011-10-10', 'studyFirstSubmitQcDate': '2008-10-10', 'dispFirstPostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-21', 'studyFirstPostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Response at Week 6', 'timeFrame': 'Baseline to Week 6', 'description': "As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \\< 150 was attained."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Clinical Remission at Week 6', 'timeFrame': 'Baseline to Week 6', 'description': 'As measured by a CDAI score of \\< 150 points.'}, {'measure': 'Number of Participants With Clinical Response at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \\< 150 was attained.'}, {'measure': 'Number of Participants With Clinical Response at Week 8', 'timeFrame': 'Baseline to Week 8', 'description': 'As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \\< 150 was attained.'}, {'measure': 'Number of Participants With Clinical Remission at Week 8', 'timeFrame': 'Baseline to Week 8', 'description': 'As measured by a CDAI score of \\< 150 points.'}, {'measure': 'Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)', 'timeFrame': 'Baseline to Week 22', 'description': 'As measured by a CDAI score of \\< 150 points.'}, {'measure': 'Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)', 'timeFrame': 'Baseline to Week 22', 'description': 'As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \\< 150 was attained.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Interleukin-12', 'Inflammation', 'Research study', 'Ustekinumab', 'CNTO1275', 'Interleukin-23'], 'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '36150926', 'type': 'DERIVED', 'citation': "Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21."}, {'pmid': '30739254', 'type': 'DERIVED', 'citation': "Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3."}, {'pmid': '28129359', 'type': 'DERIVED', 'citation': 'Di Narzo AF, Telesco SE, Brodmerkel C, Argmann C, Peters LA, Li K, Kidd B, Dudley J, Cho J, Schadt EE, Kasarskis A, Dobrin R, Hao K. High-Throughput Characterization of Blood Serum Proteomics of IBD Patients with Respect to Aging and Genetic Factors. PLoS Genet. 2017 Jan 27;13(1):e1006565. doi: 10.1371/journal.pgen.1006565. eCollection 2017 Jan.'}, {'pmid': '23075178', 'type': 'DERIVED', 'citation': "Sandborn WJ, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, Sands BE, Hanauer SB, Targan S, Rutgeerts P, Ghosh S, de Villiers WJ, Panaccione R, Greenberg G, Schreiber S, Lichtiger S, Feagan BG; CERTIFI Study Group. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012 Oct 18;367(16):1519-28. doi: 10.1056/NEJMoa1203572."}]}, 'descriptionModule': {'briefSummary': "A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.", 'detailedDescription': "In Crohn's disease there is inflammation (changes in body tissue which normally happen during injury or infection) and or ulceration (open sores) in the intestines.This occurs because the immune system (the part of the body that fights off infection) has an abnormal and overactive response against the intestine and bowel tissues of the body. Crohn's disease is usually treated with medications that either directly decrease inflammation or decrease the general activity of the immune system to improve the diarrhea, abdominal pain, and other symptoms of Crohn's Disease. Ustekinumab antibodies (natural substances made by your immune system to stick to and help remove foreign materials in your body that cause diseases) have been created to stick to and block the activity of two of the immune substances thought to cause abnormal inflammation of Crohn's disease. Patients who are eligible and who have received Remicade, Humira, or Cimzia and failed or been intolerant to one of these drugs will be randomized to either active drug (ustekinumab) or placebo. All patients will be randomized (like flipping a coin) at week 0 to be in one of 4 groups. At week 0 the study drug will be given by IV administration and at weeks 8 and 16 by subcutaneous injection. There will be 11 study visits in total and the study will continue until week 36. Blood and stool samples will be collected and studied, questionnaires to check on how you are doing in terms of your disease will be completed, an Electrocardiogram (EKG) obtained, safety evaluations conducted and diary cards distributed to be completed during the entire study. One of 4 groups: Grp 1-placebo, Grp 2-active drug 1mg/kg IV, Grp 3-active drug 3mg/kg IV, Grp 4-active drug 6mg/kg IV. Based on the clinical response status at Week 6, patients from Grps 2, 3 and 4 will be re-randomized at week 8 to receive either placebo or 90 mg SC at both weeks 8 and 16 and patients from Grp 1 will receive placebo at Week 8 and Week 16 or a 270 mg SC injection at Week 8 and 90 mg SC at Week 16."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have Crohn's disease or fistulizing Crohn's disease of at least 3 months duration\n* Must have received Remicade, adalimumab or Cimzia at a dose approved for the treatment of Crohn's disease\n* Must have failed or been intolerant to Remicade, Humira or Cimzia for treatment of Crohn's disease\n* Must be 18 years of age or older\n* Must have active Crohn's disease according to the Crohn's Disease Activity Index (CDAI \\> =220 and \\< =450).\n\nExclusion Criteria:\n\n* Patients who have had any kind of bowel resection, diversions or placement of a stoma within 6 months\n* Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the study or within 1 year after receiving study agent\n* Patients who have received Remicade, Humira or Cimzia \\< =8 weeks before the first administration of study drug\n* Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug\n* Patients with a history of or ongoing chronic or recurrent infectious disease."}, 'identificationModule': {'nctId': 'NCT00771667', 'briefTitle': "A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy", 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor, Inc.'}, 'officialTitle': "A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy", 'orgStudyIdInfo': {'id': 'CR015238'}, 'secondaryIdInfos': [{'id': 'C0743T26', 'type': 'OTHER', 'domain': 'Centocor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (IP)', 'interventionNames': ['Drug: Placebo (IP)']}, {'type': 'EXPERIMENTAL', 'label': 'Ustekinumab 1mg/kg (IP)', 'interventionNames': ['Drug: Ustekinumab 1mg/kg (IP)']}, {'type': 'EXPERIMENTAL', 'label': 'Ustekinumab 3 mg/kg (IP)', 'interventionNames': ['Drug: Ustekinumab 3 mg/kg (IP)']}, {'type': 'EXPERIMENTAL', 'label': 'Ustekinumab 6 mg/kg (IP)', 'interventionNames': ['Drug: Ustekinumab 6 mg/kg (IP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo IV - Responder - Placebo SC (MP)', 'interventionNames': ['Drug: Placebo IV - Responder - Placebo SC (MP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC', 'interventionNames': ['Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ustekinumab IV - Responder - Placebo SC (MP)', 'interventionNames': ['Drug: Ustekinumab IV - Responder - Placebo SC (MP)']}, {'type': 'EXPERIMENTAL', 'label': 'Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)', 'interventionNames': ['Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ustekinumab IV - Nonresponder - Placebo SC (MP)', 'interventionNames': ['Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP)']}, {'type': 'EXPERIMENTAL', 'label': 'Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)', 'interventionNames': ['Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)']}], 'interventions': [{'name': 'Placebo (IP)', 'type': 'DRUG', 'description': 'Induction phase (Week 0-8) (IP) - Placebo IV group', 'armGroupLabels': ['Placebo (IP)']}, {'name': 'Ustekinumab 1mg/kg (IP)', 'type': 'DRUG', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group', 'armGroupLabels': ['Ustekinumab 1mg/kg (IP)']}, {'name': 'Ustekinumab 3 mg/kg (IP)', 'type': 'DRUG', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group', 'armGroupLabels': ['Ustekinumab 3 mg/kg (IP)']}, {'name': 'Ustekinumab 6 mg/kg (IP)', 'type': 'DRUG', 'description': 'Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group', 'armGroupLabels': ['Ustekinumab 6 mg/kg (IP)']}, {'name': 'Placebo IV - Responder - Placebo SC (MP)', 'type': 'DRUG', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16', 'armGroupLabels': ['Placebo IV - Responder - Placebo SC (MP)']}, {'name': 'Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)', 'type': 'DRUG', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16', 'armGroupLabels': ['Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC']}, {'name': 'Ustekinumab IV - Responder - Placebo SC (MP)', 'type': 'DRUG', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16', 'armGroupLabels': ['Ustekinumab IV - Responder - Placebo SC (MP)']}, {'name': 'Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)', 'type': 'DRUG', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16', 'armGroupLabels': ['Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)']}, {'name': 'Ustekinumab IV - Nonresponder - Placebo SC (MP)', 'type': 'DRUG', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Placebo SC at Week 8 and Week 16', 'armGroupLabels': ['Ustekinumab IV - Nonresponder - Placebo SC (MP)']}, {'name': 'Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)', 'type': 'DRUG', 'description': 'Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16', 'armGroupLabels': ['Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Roseville', 'state': 'California', 'country': 'United States', 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