Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07731672). StuddyBuddy aggregates publicly available trial information.