Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 3:31 PM
Study NCT ID:
NCT01490450
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2011-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
Sponsor:
Organization:
Raw JSON
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'phone': '610-878-4000', 'title': 'Study Director', 'organization': 'CSL Behring'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 weeks per participant', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 19, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 22, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 20, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 27, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}, {'value': '46.3', 'groupId': 'OG001'}, {'value': '52.4', 'groupId': 'OG002'}, {'value': '39.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 16 weeks', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (MITT) defined as all randomized subjects that received at least one dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}], 'classes': [{'title': 'week 16', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '4.9', 'groupId': 'OG003'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}, {'value': '19.5', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '12.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16 and Week 24', 'description': "To calculate the PASI score, the psoriasis plaques found on each body region are graded for their combined redness, thickness, and scaliness. The severity of the plaques in each region is graded on a 0 to 4 scale, with 0 meaning no involvement and 4 meaning severe involvement. Next, the amount of surface area on each body region that is covered by the plaques is calculated. The total surface area affected by psoriasis is graded from 0 to 6, with 0 meaning no involvement and 6 meaning greater than 90 percent of the region covered in plaques.\n\nThese grades are then fed into an equation to determine the patient's PASI score. The PASI score then is used as a clinical assessment of the patient's psoriasis involvement. A person free of psoriasis has a score of 0 and the score could be as high as 72.\n\nPASI 75 means that the person's PASI score dropped by 75 percent as a result of the psoriasis treatment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving ACR50 and ACR70 Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}], 'classes': [{'title': 'ACR50 (16 weeks)', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '29.3', 'groupId': 'OG001'}, {'value': '35.7', 'groupId': 'OG002'}, {'value': '17.1', 'groupId': 'OG003'}]}]}, {'title': 'ACR50 (24 weeks)', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}, {'value': '35.7', 'groupId': 'OG002'}, {'value': '24.4', 'groupId': 'OG003'}]}]}, {'title': 'ACR70 (16 weeks)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '4.9', 'groupId': 'OG003'}]}]}, {'title': 'ACR70 (24 weeks)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '19.5', 'groupId': 'OG001'}, {'value': '23.8', 'groupId': 'OG002'}, {'value': '12.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16 and Week 24', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving ACR20 Response Rate at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '56.1', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}, {'value': '39.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}], 'classes': [{'title': 'week 16', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}, {'value': '39.0', 'groupId': 'OG003'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}, {'value': '51.2', 'groupId': 'OG001'}, {'value': '47.6', 'groupId': 'OG002'}, {'value': '36.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 16 and Week 24', 'description': 'For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). There are 20 questions in eight categories of functioning - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The highest component score in each category determines the score for the category, unless aids or devices are required. Dependence on equipment or physical assistance increases a lower score to the level of 2 to more accurately represent underlying disability. The eight category scores are averaged into an overall HAQ score on a scale from zero (no disability) to three (completely disabled). The scale is not truly continuous but has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3).\n\nResponse is measured by a reduction of at least 0.3 unit from baseline in HAQ index.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}], 'classes': [{'title': 'Mental component', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.507', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.502', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '1.478', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '1.516', 'groupId': 'OG003'}]}]}, {'title': 'Physical component', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.236', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '1.236', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '1.217', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '1.248', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline at Week 24 in SF-36 Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}], 'classes': [{'title': 'Mental component', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.646', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.538', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '1.548', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '1.689', 'groupId': 'OG003'}]}]}, {'title': 'Physical component', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.420', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.360', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '1.363', 'groupId': 'OG002'}, {'value': '6.4', 'spread': '1.461', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-clazakizumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG001', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'OG002', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks'}, {'id': 'FG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'FG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'FG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Request to discontinue treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'No longer met study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '165', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subcutaneous, every 4 weeks for 24 weeks'}, {'id': 'BG001', 'title': 'Clazakizumab (25mg)', 'description': 'Subcutaneous, 25 mg, every 4 weeks, for 24 weeks'}, {'id': 'BG002', 'title': 'Clazakizumab (100mg)', 'description': 'Subcutaneous, 100 mg, every 4 weeks, for 24 weeks'}, {'id': 'BG003', 'title': 'Clazakizumab (200mg)', 'description': 'Subcutaneous, 200 mg, every 4 weeks, for 24 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '10.53', 'groupId': 'BG000'}, {'value': '49.8', 'spread': '14.05', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '10.84', 'groupId': 'BG002'}, {'value': '44.7', 'spread': '13.75', 'groupId': 'BG003'}, {'value': '47.9', 'spread': '12.43', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2015-07-24', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2011-11-14', 'dispFirstSubmitQcDate': '2015-07-24', 'resultsFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2011-12-09', 'dispFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-07', 'studyFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)', 'timeFrame': 'At 16 weeks', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate', 'timeFrame': 'Week 16 and Week 24', 'description': "To calculate the PASI score, the psoriasis plaques found on each body region are graded for their combined redness, thickness, and scaliness. The severity of the plaques in each region is graded on a 0 to 4 scale, with 0 meaning no involvement and 4 meaning severe involvement. Next, the amount of surface area on each body region that is covered by the plaques is calculated. The total surface area affected by psoriasis is graded from 0 to 6, with 0 meaning no involvement and 6 meaning greater than 90 percent of the region covered in plaques.\n\nThese grades are then fed into an equation to determine the patient's PASI score. The PASI score then is used as a clinical assessment of the patient's psoriasis involvement. A person free of psoriasis has a score of 0 and the score could be as high as 72.\n\nPASI 75 means that the person's PASI score dropped by 75 percent as a result of the psoriasis treatment."}, {'measure': 'Percent of Participants Achieving ACR50 and ACR70 Response Rate', 'timeFrame': 'Week 16 and Week 24', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).'}, {'measure': 'Percent of Participants Achieving ACR20 Response Rate at Week 24', 'timeFrame': 'Week 24', 'description': 'The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).'}, {'measure': 'Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response', 'timeFrame': 'Weeks 16 and Week 24', 'description': 'For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). There are 20 questions in eight categories of functioning - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The highest component score in each category determines the score for the category, unless aids or devices are required. Dependence on equipment or physical assistance increases a lower score to the level of 2 to more accurately represent underlying disability. The eight category scores are averaged into an overall HAQ score on a scale from zero (no disability) to three (completely disabled). The scale is not truly continuous but has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3).\n\nResponse is measured by a reduction of at least 0.3 unit from baseline in HAQ index.'}, {'measure': 'Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores', 'timeFrame': 'Baseline and Week 16', 'description': 'The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.'}, {'measure': 'Mean Change From Baseline at Week 24 in SF-36 Scores', 'timeFrame': 'Baseline and Week 24', 'description': 'The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.'}, {'measure': 'Number of Participants With Anti-clazakizumab Antibodies', 'timeFrame': 'Up to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Arthritis, Psoriatic']}, 'referencesModule': {'references': [{'pmid': '27059799', 'type': 'DERIVED', 'citation': 'Mease PJ, Gottlieb AB, Berman A, Drescher E, Xing J, Wong R, Banerjee S. The Efficacy and Safety of Clazakizumab, an Anti-Interleukin-6 Monoclonal Antibody, in a Phase IIb Study of Adults With Active Psoriatic Arthritis. Arthritis Rheumatol. 2016 Sep;68(9):2163-73. doi: 10.1002/art.39700.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed\n* Inadequate response to NSAID and/or non-biologic DMARD\n* Minimum of 3 swollen and 3 tender joints\n* Active psoriatic skin lesions over minimum 3% body surface area\n* high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL\n\nExclusion Criteria:\n\n* Previously received or currently receiving concomitant biologic therapy'}, 'identificationModule': {'nctId': 'NCT01490450', 'briefTitle': 'Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging, Multi-Center Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection in Adults With Active Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'IM133-004'}, 'secondaryIdInfos': [{'id': '2011-004016-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PBO: Placebo matching BMS-945429', 'interventionNames': ['Biological: Placebo matching BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-945429 (25mg)', 'interventionNames': ['Biological: BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-945429 (100mg)', 'interventionNames': ['Biological: BMS-945429']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-945429 (200mg)', 'interventionNames': ['Biological: BMS-945429']}], 'interventions': [{'name': 'Placebo matching BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label', 'armGroupLabels': ['PBO: Placebo matching BMS-945429']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label', 'armGroupLabels': ['BMS-945429 (25mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label', 'armGroupLabels': ['BMS-945429 (100mg)']}, {'name': 'BMS-945429', 'type': 'BIOLOGICAL', 'description': 'Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label', 'armGroupLabels': ['BMS-945429 (200mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Arthritis Medical Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Arthritis Clinic', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06611', 'city': 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