Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases

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.

NCT Number	NCT07731672
Lead Sponsor	University of Sao Paulo General Hospital Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions	Autoimmune Rheumatic Diseases, Prevention
Enrollment	1,660 participants
Start Date	2026-08-01
Primary Completion	2030-07-30 (estimated)
Study Completion	2031-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-31