Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00267969
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2005-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': '1-800-457-6399', 'title': 'Dir. Clinical Research', 'organization': 'Centocor Research & Development, Inc.'}, 'certainAgreement': {'otherDetails': 'Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The count of patients with any nonserious adverse event (NAE) excludes patients who only had NAE that occured in \\<=5% of patients. This information may vary from existing approved labeling and publications due to the requirements of this website.'}}, 'adverseEventsModule': {'timeFrame': '264 weeks', 'description': 'In adverse events reporting: 1 patient not included was randomized in Ustekinumab 90 mg Controlled period (CP) but not treated. 1 patient included in Ustekinumab 45 mg (after CP) and 6 patients included in Ustekinumab 90 mg (after CP) had discontinued study agent during the CP but had follow-up after CP.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo group', 'otherNumAtRisk': 255, 'otherNumAffected': 81, 'seriousNumAtRisk': 255, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Ustekinumab 45 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 45 mg group', 'otherNumAtRisk': 255, 'otherNumAffected': 102, 'seriousNumAtRisk': 255, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Ustekinumab 90 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 90 mg group', 'otherNumAtRisk': 255, 'otherNumAffected': 84, 'seriousNumAtRisk': 255, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Placebo -> Ustekinumab 45 mg (After CP)', 'description': 'After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -\\> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.', 'otherNumAtRisk': 123, 'otherNumAffected': 110, 'seriousNumAtRisk': 123, 'seriousNumAffected': 20}, {'id': 'EG004', 'title': 'Placebo -> Ustekinumab 90 mg (After CP)', 'description': 'After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -\\> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.', 'otherNumAtRisk': 120, 'otherNumAffected': 102, 'seriousNumAtRisk': 120, 'seriousNumAffected': 18}, {'id': 'EG005', 'title': 'Ustekinumab 45 mg (After CP)', 'description': 'After Controlled period (Week 12-264) - patients receiving ustekinumab 45 mg at Weeks 0 and 4 -\\> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.', 'otherNumAtRisk': 255, 'otherNumAffected': 207, 'seriousNumAtRisk': 255, 'seriousNumAffected': 38}, {'id': 'EG006', 'title': 'Ustekinumab 90 mg (After CP)', 'description': 'After Controlled period (Week 12-264) - patients receiving ustekinumab 90 mg at Weeks 0 and 4 -\\> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.', 'otherNumAtRisk': 251, 'otherNumAffected': 207, 'seriousNumAtRisk': 251, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 25}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 23}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 28}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 36}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 70}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 75}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 37}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 43}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 34}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 82}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 77}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 22}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 17}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 31}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 23}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Psoriatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 24}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.'}, {'id': 'OG001', 'title': 'Ustekinumab 45 mg', 'description': 'Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.'}, {'id': 'OG002', 'title': 'Ustekinumab 90 mg', 'description': 'Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel (CMH) chi square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline weight \\[≤ 90kg vs \\> 90 kg)\\].', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05", 'groupDescription': 'Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 750 patients (250 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \\[\\<=90kg vs \\> 90 kg). For all the scenarios evaluated, the power is \\>99% at an overall significance level of 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel (CMH) chi square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline weight \\[≤ 90kg vs \\> 90 kg)\\].', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \\[best\\] - 72 \\[worst\\]) at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat. All patients randomized were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.'}, {'id': 'OG001', 'title': 'Ustekinumab 45 mg', 'description': 'Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.'}, {'id': 'OG002', 'title': 'Ustekinumab 90 mg', 'description': 'Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel(CMH) chi square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline weight \\[≤ 90kg vs \\> 90 kg)\\].', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first", 'groupDescription': 'Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel (CMH) chi square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline weight \\[≤ 90kg vs \\> 90 kg)\\].', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The PGA is used to determine the participant's psoriasis lesions overall at a given time point. Overall lesions will be graded as : (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score ranging from 0 \\[best\\] to 5 \\[worst\\].", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat. All patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.'}, {'id': 'OG001', 'title': 'Ustekinumab 45 mg', 'description': 'Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.'}, {'id': 'OG002', 'title': 'Ustekinumab 90 mg', 'description': 'Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '3.0'}, {'value': '-6.0', 'groupId': 'OG001', 'lowerLimit': '-12.0', 'upperLimit': '-3.0'}, {'value': '-7.0', 'groupId': 'OG002', 'lowerLimit': '-12.0', 'upperLimit': '-4.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA on van der Waerden normal scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Treatment and patient's baseline weight (≤ 90kg vs \\> 90 kg) as factors in the model", 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first", 'groupDescription': 'Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.', 'statisticalMethod': 'ANOVA on van der Waerden normal scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Treatment and patient's baseline weight (≤ 90kg vs \\> 90 kg) as factors in the model", 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Week 0), Week 12', 'description': 'Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at Week 12. This DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were included in the analysis according to the assigned treatment groups. Zero change is imputed if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '159', 'groupId': 'OG004'}, {'value': '162', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Ustekinumab 45 mg Withdrawal Group', 'description': 'Patients received ustekinumab 45 mg at Weeks 0, 4, 16 and 28.'}, {'id': 'OG001', 'title': 'Group 2: Ustekinumab 45 mg Every 12 Weeks', 'description': 'Patients received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.'}, {'id': 'OG002', 'title': 'Group 3: Ustekinumab 90 mg Withdrawal', 'description': 'Patients received ustekinumab 90 mg at Weeks 0, 4, 16 and 28.'}, {'id': 'OG003', 'title': 'Group 4: Ustekinumab 90 mg Every 12 Weeks', 'description': 'Patients received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.'}, {'id': 'OG004', 'title': 'Group 5: Withdrawal Combined Group', 'description': 'Groups 1 and 3 (Withdrawal Combined)'}, {'id': 'OG005', 'title': 'Group 6: Combined Ustekinumab Every 12 Weeks', 'description': 'Groups 2 and 4 (Combined Ustekinumab every 12 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '144', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel (CMH) chi square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline weight \\[≤ 90kg vs \\> 90 kg)\\].', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel (CMH) chi square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline weight \\[≤ 90kg vs \\> 90 kg)\\].', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested', 'groupDescription': 'Null Hypothesis: No difference between combined maintenance group and the combined withdrawal group, ustekinumab 90 mg maintenance group and the withdrawal group, ustekinumab 45 mg maintenance group and the withdrawal group at an overall significance level of 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel (CMH) chi square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline weight \\[≤ 90kg vs \\> 90 kg)\\].', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \\[best\\] - 72 \\[worst\\]) at Week 52 in participants randomly assigned to a treatment group at Week 40. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo group'}, {'id': 'FG001', 'title': 'Ustekinumab 45 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 45 mg group'}, {'id': 'FG002', 'title': 'Ustekinumab 90 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 90 mg group'}, {'id': 'FG003', 'title': 'Placebo -> Ustekinumab 45 mg (After CP)', 'description': 'After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -\\> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.'}, {'id': 'FG004', 'title': 'Placebo -> Ustekinumab 90 mg (After CP)', 'description': 'After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -\\> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.'}, {'id': 'FG005', 'title': 'Ustekinumab 45 mg (After CP)', 'description': 'After Controlled period (Week 12-264) - patients receiving ustekinumab 45 mg at Weeks 0 and 4 -\\> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.'}, {'id': 'FG006', 'title': 'Ustekinumab 90 mg (After CP)', 'description': 'After Controlled period (Week 12-264) - patients receiving ustekinumab 90 mg at Weeks 0 and 4 -\\> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.'}], 'periods': [{'title': 'Controlled Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of patients randomized', 'groupId': 'FG000', 'numSubjects': '255'}, {'comment': 'Number of patients randomized', 'groupId': 'FG001', 'numSubjects': '255'}, {'comment': 'Number of patients randomized', 'groupId': 'FG002', 'numSubjects': '256'}, {'comment': '"0" in column indicates this reporting group is not relevant to Controlled Period.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Controlled Period.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Controlled Period.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Controlled Period.', 'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '254'}, {'groupId': 'FG002', 'numSubjects': '245'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', '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'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'After Controlled Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '"0" in column indicates this reporting group is not relevant to after Controlled Period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to after Controlled Period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to after Controlled Period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '123'}, {'groupId': 'FG004', 'numSubjects': '120'}, {'groupId': 'FG005', 'numSubjects': '254'}, {'groupId': 'FG006', 'numSubjects': '245'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '87'}, {'groupId': 'FG004', 'numSubjects': '85'}, {'groupId': 'FG005', 'numSubjects': '172'}, {'groupId': 'FG006', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '35'}, {'groupId': 'FG005', 'numSubjects': '82'}, {'groupId': 'FG006', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '23'}, {'groupId': 'FG006', 'numSubjects': '21'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '28'}, {'groupId': 'FG006', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '22'}, {'groupId': 'FG006', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'In this study, 766 patients were randomized in North America and Europe to receive either placebo or ustekinumab (CNTO 1275).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}, {'value': '766', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.'}, {'id': 'BG001', 'title': 'Ustekinumab 45 mg', 'description': 'Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.'}, {'id': 'BG002', 'title': 'Ustekinumab 90 mg', 'description': 'Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'spread': '11.32', 'groupId': 'BG000'}, {'value': '44.8', 'spread': '12.48', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '11.27', 'groupId': 'BG002'}, {'value': '45.3', 'spread': '11.71', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '235', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}, {'value': '531', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 766}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2005-12-20', 'resultsFirstSubmitDate': '2009-10-23', 'studyFirstSubmitQcDate': '2005-12-20', 'lastUpdatePostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-23', 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.', 'timeFrame': 'Week 12', 'description': "The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \\[best\\] - 72 \\[worst\\]) at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12', 'timeFrame': 'Week 12', 'description': "The PGA is used to determine the participant's psoriasis lesions overall at a given time point. Overall lesions will be graded as : (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score ranging from 0 \\[best\\] to 5 \\[worst\\]."}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12', 'timeFrame': 'Baseline (Week 0), Week 12', 'description': 'Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at Week 12. This DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).'}, {'measure': 'Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52', 'timeFrame': 'Week 52', 'description': "The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \\[best\\] - 72 \\[worst\\]) at Week 52 in participants randomly assigned to a treatment group at Week 40. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ustekinumab', 'CNTO1275', 'Plaque type Psoriasis', 'Interleukin-23', 'IL-23', 'Psoriasis', 'Interleukin 12', 'IL-12'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'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': '18486739', 'type': 'DERIVED', 'citation': 'Leonardi CL, Kimball AB, Papp KA, Yeilding N, Guzzo C, Wang Y, Li S, Dooley LT, Gordon KB; PHOENIX 1 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008 May 17;371(9625):1665-74. doi: 10.1016/S0140-6736(08)60725-4.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.', 'detailedDescription': 'This is a randomized (patients are assigned to different treatments based on chance), double blind (neither the patient nor the physician knows whether medication or placebo \\[an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study\\] is being taken, or at what dosage), parallel-group (each group of patients are treated at the same time), multicenter study to determine the effectiveness and safety of two different doses of ustekinumab administered subcutaneously (under the skin) as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). 766 patients will be randomized to Group 1 (ustekinumab 45 mg), Group 2 (ustekinumab 90 mg) and Group 3 (placebo) at Week 0. The study was designed to evaluate the effectiveness and safety of 2 dose regimens of ustekinumab: (1) 45 mg at Weeks 0 and 4 followed by 45 mg every 12 weeks maintenance therapy (treatment designed to help the original primary treatment succeed) and (2) 90 mg at Weeks 0 and 4 followed by 90 mg every 12 weeks maintenance therapy. The study will consist of 4 periods: (1) Placebo-controlled portion of study \\[Week 0 to Week 12\\] during which the safety and effectiveness of 2 doses (45mg and 90mg) of ustekinumab will be compared to placebo; (2) Placebo crossover and active treatment portion of study \\[Week 12 to Week 40\\] during which patients randomized to receive placebo at Week 0 will crossover to receive ustekinumab, and all patients will receive active treatment; (3) Randomized withdrawal portion of study \\[beginning at Week 40\\] during which patients who received ustekinumab \\[45mg or 90mg every 12 weeks\\] at Week 0 and are responding to it, will be randomized either to placebo or continued maintenance therapy with ustekinumab; and (4) Long-term extension \\[from Week 52 to Week 264 (ie, 5 years)\\] period during which the safety and effectiveness of ustekinumab long-term use will be evaluated in patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with plaque-type psoriasis diagnosed at least 6 months prior and covering at least 10% of total body surface areas\n* Have psoriasis area-and-severity index score of \\>=12\n* Patients who are considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis\n* Have no history of latent or active TB\n\nExclusion Criteria:\n\n* Currently have nonplaque forms of psoriasis or drug-induced psoriasis\n* Have any therapeutic agent targeted at reducing IL-12 or IL-23\n* Have had a BCG vaccination within the previous 12 months\n* Have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months\n* Have or ever have had a nontuberculous mycobacterial infection or opportunistic infection\n* Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C\n* Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease\n* Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)'}, 'identificationModule': {'nctId': 'NCT00267969', 'acronym': 'PHOENIX1', 'briefTitle': 'A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis', 'nctIdAliases': ['NCT01585714'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor Research & Development, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Ustekinumab (CNTO 1275) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis', 'orgStudyIdInfo': {'id': 'CR006328'}, 'secondaryIdInfos': [{'id': 'C0743T08', 'type': 'OTHER', 'domain': 'Centocor Research & Development, Inc., PA, USA'}, {'id': '2005-003529-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ustekinumab 45 mg', 'description': 'Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.', 'interventionNames': ['Drug: ustekinumab']}, {'type': 'EXPERIMENTAL', 'label': 'ustekinumab 90 mg', 'description': 'Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.', 'interventionNames': ['Drug: ustekinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'ustekinumab', 'type': 'DRUG', 'otherNames': ['CNTO 1275'], 'description': 'Type = exact number, Form = solution for injection, Number = 45 and 90, Unit = mg, Route = subcutaneous (SC) administered at Weeks 0, 4 and 16. Both treatments (45 mg and 90 mg) administered every 12 weeks after Week 16 depending on clinical response.', 'armGroupLabels': ['ustekinumab 45 mg', 'ustekinumab 90 mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Form = solution for injection, route = SC administered at Weeks 0 and 4. At Weeks 12 and 16, placebo will be crossed over to receive ustekinumab 45 mg or 90 mg.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Lake Oswego', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.42067, 'lon': -122.67065}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Edegem', 'country': 'Belgium', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'North Bay', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 46.3168, 'lon': -79.46633}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Centocor Research & Development, Inc. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centocor Research & Development, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centocor Research & Development, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}