Viewing Study NCT02029495

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Ignite Creation Date: 2025-12-24 @ 1:58 PM
Ignite Modification Date: 2026-02-18 @ 10:42 AM
Study NCT ID: NCT02029495
Status: TERMINATED
Last Update Posted: 2017-05-19
First Post: 2014-01-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571216', 'term': 'brodalumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'binu.alexander@valeant.com', 'phone': '908', 'title': 'Director of Clinical Trials', 'organization': 'Valeant Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '210 mg Brodalumab', 'description': 'Administered via subcutaneous injections\n\n210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection', 'otherNumAtRisk': 158, 'otherNumAffected': 84, 'seriousNumAtRisk': 158, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': '140 mg Brodalumab', 'description': 'Administered via subcutaneous injection\n\n140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection', 'otherNumAtRisk': 158, 'otherNumAffected': 79, 'seriousNumAtRisk': 158, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Administered via subcutaneous injection until week 24.\n\nPlacebo: Placebo administered via subcutaneous injection until week 24.', 'otherNumAtRisk': 159, 'otherNumAffected': 71, 'seriousNumAtRisk': 159, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrheoa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoriatic Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed Mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Odema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Odema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Squimos Cell Carcinoma of the Vulva', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignant Melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lens Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug reaction with Eosinaphilia and Systematic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Synovial Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral Disc protusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoriatic Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Iris Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Keratorhexis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'American College of Rheumatology (ACR) 20 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '210 mg Brodalumab', 'description': 'Administered via subcutaneous injections\n\n210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection'}, {'id': 'OG001', 'title': '140 mg Brodalumab', 'description': 'Administered via subcutaneous injection\n\n140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Administered via subcutaneous injection until week 24.\n\nPlacebo: Placebo administered via subcutaneous injection until week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '21.8', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '33.1'}, {'value': '36.5', 'groupId': 'OG002', 'lowerLimit': '22.8', 'upperLimit': '45.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': "An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index (PASI)75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '210 mg Brodalumab', 'description': 'Administered via subcutaneous injections\n\n210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection'}, {'id': 'OG001', 'title': '140 mg Brodalumab', 'description': 'Administered via subcutaneous injection\n\n140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Administered via subcutaneous injection until week 24.\n\nPlacebo: Placebo administered via subcutaneous injection until week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000', 'lowerLimit': '57.6', 'upperLimit': '82.9'}, {'value': '55.6', 'groupId': 'OG001', 'lowerLimit': '27.9', 'upperLimit': '56.6'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 Weeks', 'description': 'PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '210 mg Brodalumab', 'description': 'Administered via subcutaneous injections\n\n210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection'}, {'id': 'FG001', 'title': '140 mg Brodalumab', 'description': 'Administered via subcutaneous injection\n\n140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Administered via subcutaneous injection until week 24.\n\nPlacebo: Placebo administered via subcutaneous injection until week 24.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '158'}, {'groupId': 'FG002', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '158'}, {'groupId': 'FG002', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '478', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '210 mg Brodalumab', 'description': 'Administered via subcutaneous injections\n\n210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection'}, {'id': 'BG001', 'title': '140 mg Brodalumab', 'description': 'Administered via subcutaneous injection\n\n140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Administered via subcutaneous injection until week 24.\n\nPlacebo: Placebo administered via subcutaneous injection until week 24.'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '427', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '12.24', 'groupId': 'BG000'}, {'value': '49.9', 'spread': '12.80', 'groupId': 'BG001'}, {'value': '48.1', 'spread': '11.79', 'groupId': 'BG002'}, {'value': '49', 'spread': '12.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '248', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '459', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 478}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'dispFirstSubmitDate': '2016-03-14', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2014-01-06', 'dispFirstSubmitQcDate': '2016-03-14', 'resultsFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2014-01-06', 'dispFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-07', 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American College of Rheumatology (ACR) 20 Response', 'timeFrame': '16 weeks', 'description': "An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components)."}], 'secondaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index (PASI)75', 'timeFrame': '16 Weeks', 'description': 'PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Psoriatic Arthritis', 'Brodalumab', 'AMG 827'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.', 'detailedDescription': 'The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16 and week 24. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding the distal interphalangeal joints)).\n* Subjects must have at least 1 psoriatic skin lesion as well as either ≥ 1 erosion on a centrally read radiograph or an elevated CRP.\n\nExclusion Criteria:\n\n* Subject has known history of active tuberculosis.\n* Subject has a planned surgical intervention between baseline and the week 52 evaluation.\n* Subject has an active infection or history of infections.\n* Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the Investigator to be clinically significant and uncontrolled.\n* Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.\n* Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)\n* Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety'}, 'identificationModule': {'nctId': 'NCT02029495', 'acronym': 'AMVISION-1', 'briefTitle': 'Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-1', 'orgStudyIdInfo': {'id': '20090406'}, 'secondaryIdInfos': [{'id': '2013-003554-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '210 mg brodalumab', 'description': 'Administered via subcutaneous injections', 'interventionNames': ['Drug: 210 mg brodalumab']}, {'type': 'EXPERIMENTAL', 'label': '140 mg brodalumab', 'description': 'Administered via subcutaneous injection', 'interventionNames': ['Drug: 140 mg brodalumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered via subcutaneous injection until week 24.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '210 mg brodalumab', 'type': 'DRUG', 'otherNames': ['AMG 827'], 'description': '210 mg brodalumab administered via subcutaneous injection', 'armGroupLabels': ['210 mg brodalumab']}, {'name': '140 mg brodalumab', 'type': 'DRUG', 'otherNames': ['AMG 827'], 'description': '140 mg brodalumab administered via subcutaneous injection', 'armGroupLabels': ['140 mg brodalumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered via subcutaneous injection until week 24.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35406', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': 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