Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT06563635
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2023-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequency of Tuberculosis in Psoriasis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 719}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2024-08-19', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tuberculosis rate', 'timeFrame': 'patients from June 2007 to January 2023, up to 15 years', 'description': 'number of patients with tuberculosis infection after receiving TNF inhibitor therapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psoriasis', 'tnf inhibitor', 'tuberculosis'], 'conditions': ['Psoriasis Vulgaris', 'Tuberculosis']}, 'descriptionModule': {'briefSummary': 'Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center.', 'detailedDescription': 'Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center. TNF inhibitor therapy may increase the risk for tuberculosis infection. According to medical data in our hospital in last 15 years, tuberculosis rate of psoriasis patients receiving etanercept, adalimumab and infliximab will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'psoriasis patients receiving TNF inhibitor therapy in a single center in 15 years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* psoriasis patients receiving TNF inhibitor therapy\n\nExclusion Criteria:\n\n* patients without TNF inhibitor therapy'}, 'identificationModule': {'nctId': 'NCT06563635', 'briefTitle': 'Frequency of Tuberculosis in Psoriasis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Frequency of Tuberculosis in Psoriasis Patients Using Anti-TNF Therapy During 15 Years of Follow-up.', 'orgStudyIdInfo': {'id': 'E-54022451-050.05.04-116589'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'etanercept', 'description': 'psoriasis patients receiving etanercept therapy'}, {'label': 'infliximab', 'description': 'psoriasis patients receiving infliximab therapy'}, {'label': 'adalimumab', 'description': 'psoriasis patients receiving adalimumab therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}