Raw JSON
{'hasResults': False, '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': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and intensity of Adverse Events (AEs) recorded through the study period', 'timeFrame': 'Week 124'}, {'measure': 'Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20', 'timeFrame': 'Week 124', 'description': "ACR20 response is an aggregate of:\n\n1\\. at least 20% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments:\n\n1. physician's global assessment of disease activity\n2. patient's global assessment of disease activity\n3. patient's assessment of pain\n4. patient's self-assessed disability based on health assessment questionnaire\n5. c-reactive protein"}, {'measure': 'Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50', 'timeFrame': 'Week 124', 'description': "ACR50 response is an aggregate of:\n\n1\\. at least 50% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments:\n\n1. physician's global assessment of disease activity\n2. patient's global assessment of disease activity\n3. patient's assessment of pain\n4. patient's self-assessed disability based on health assessment questionnaire\n5. c-reactive protein"}, {'measure': 'Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70', 'timeFrame': 'Week 124', 'description': "ACR70 response is an aggregate of:\n\n1\\. at least 70% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments:\n\n1. physician's global assessment of disease activity\n2. patient's global assessment of disease activity\n3. patient's assessment of pain\n4. patient's self-assessed disability based on health assessment questionnaire\n5. c-reactive protein"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'descriptionModule': {'briefSummary': 'An open label phase 3 study', 'detailedDescription': 'Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects possess the ability to understand the requirements of the study.\n* Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.\n* Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.\n* Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.\n\nExclusion Criteria:\n\n* Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.\n* Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP.\n* Subject has previously been enrolled in this long-term extension study.\n* Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.'}, 'identificationModule': {'nctId': 'NCT04991116', 'briefTitle': 'Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.', 'orgStudyIdInfo': {'id': 'TILD-21-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TILD q12 weeks', 'interventionNames': ['Drug: TILD sub-cutaneous (SC) injection']}], 'interventions': [{'name': 'TILD sub-cutaneous (SC) injection', 'type': 'DRUG', 'description': '1 mL injection of study medication', 'armGroupLabels': ['TILD q12 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 50', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 80', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 65', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 105', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91722', 'city': 'Covina', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 30', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 110', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 17', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '91320', 'city': 'Thousand Oaks', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 15', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '33825', 'city': 'Avon Park', 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'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 05', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34751', 'city': 'Ocoee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 32', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SunPharma Site no 22', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 52', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '60467', 'city': 'Orland Park', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 51', 'geoPoint': {'lat': 41.63031, 'lon': -87.85394}}, {'zip': '60195', 'city': 'Schaumburg', 'state': 'Illinois', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Sunpharma site no 49', 'geoPoint': {'lat': 42.03336, 'lon': -88.08341}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 47', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 20', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 14', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63119', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 104', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 48', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma Site no 27', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 33', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 34', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28451', 'city': 'Leland', 'state': 'North Carolina', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 111', 'geoPoint': {'lat': 34.25628, 'lon': -78.04471}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 53', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '58701', 'city': 'Minot', 'state': 'North Dakota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 35', 'geoPoint': {'lat': 48.23251, 'lon': -101.29627}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 11', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Sunpharma site no 31', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '77521', 'city': 'Baytown', 'state': 'Texas', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Sunpharma site no. 08', 'geoPoint': {'lat': 29.7355, 'lon': -94.97743}}, {'zip': '77521', 'city': 'Baytown', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 13', 'geoPoint': {'lat': 29.7355, 'lon': -94.97743}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma Site no 28', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no 109', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 03', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sunpharma site no. 16', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77375', 'city': 'Tomball', 'state': 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'Tasmania', 'status': 'TERMINATED', 'country': 'Australia', 'facility': 'Sunpharma site no. 24', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': 'G9A 3X2', 'city': 'Trois-Rivières', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Sunpharma site no 95', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': '638 00', 'city': 'Brno', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Sunpharma site no 36', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '12800', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Sunpharma site no 67', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '140 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Sunpharma site no 89', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '760 01', 'city': 'Zlín', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Sunpharma site no 82', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'zip': 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'country': 'India', 'facility': 'Sunpharma site no 103', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '411007', 'city': 'Pune', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Sunpharma site no 114', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '500003', 'city': 'Secunderabad', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'India', 'facility': 'Sunpharma site no 102', 'geoPoint': {'lat': 17.50427, 'lon': 78.54263}}, {'zip': '41014', 'city': 'Sevilla', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Sunpharma site no 94'}, {'zip': '37134', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Sunpharma site no 90', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '160-0023', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sunpharma site no 73'}, {'zip': '802-8561', 'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sunpharma site no 45', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '173-8606', 'city': 'Itabashi-ku', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sunpharma site no 84'}, {'zip': '860-8556', 'city': 'Kumamoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sunpharma site no 46', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '181-8611', 'city': 'Mitaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sunpharma site no 72', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}, {'zip': '889-1692', 'city': 'Miyazaki', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sunpharma site no 79', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'zip': '467-8602', 'city': 'Nagoya', 'status': 'WITHDRAWN', 'country': 'Japan', 'facility': 'Sunpharma site no 78', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '545-8586', 'city': 'Sendai', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sunpharma site no 64', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '980-8574', 'city': 'Sendai', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sunpharma site no 63', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Tsu', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sunpharma site no 87', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '15-351', 'city': 'Bialystok', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Sunpharma site no 43', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '15-879', 'city': 'Bialystok', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Sunpharma site no 69', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '30-033', 'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Sunpharma site no 56', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-607', 'city': 'Lublin', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Sunpharma site no 81', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, 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