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NCT07731672
Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases
Conditions: Autoimmune Rheumatic Diseases, Prevention
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 1660
Sponsor: University of Sao Paulo General Hospital
Location: Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP São Paulo São Paulo
Summary
This is a prospective, randomized, controlled study designed to evaluate the effectiveness of annual re-screening for tuberculosis infection (TBI) (previous) in patients with autoimmune rheumatic diseases (ARDs) receiving biologic and/or immunosuppressive therapy.
Patients with negative baseline TBI screening will be randomized to undergo annual re-screening using interferon-gamma release assay (IGRA) or to a control group without routine re-screening.
Patients with newly detected TBI will receive preventive treatment. The primary objective is to assess whether annual re-screening combined with TBI treatment reduces the incidence of active tuberculosis. Secondary objectives include determining TBI conversion rates and identifying risk factors for infection.
Eligibility Criteria
Inclusion Criteria:
* Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria
* negative baseline screening for tuberculosis infection.
Exclusion Criteria:
* History of tuberculosis infection or disease
* Radiographic evidence suggestive of prior TB
* Previous treatment for TBD or TBI
* Positive baseline TB screening;
* Follow-up shorter than 12 months
Source: ClinicalTrials.gov (NCT07731672). StuddyBuddy aggregates publicly available trial information.