Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases

Starting soon · Not applicable

Conditions studied: Autoimmune Rheumatic Diseases, Prevention

In brief

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.

Key facts

Study ID

NCT07731672

Run by

University of Sao Paulo General Hospital

People needed

1660

Starts

2026-08-01

Expected to finish

2031-07-30

Last updated by the study team

2026-07-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria
• negative baseline screening for tuberculosis infection.

You may not qualify if…

• 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

Where it is running

• Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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