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Yearly tuberculosis re-testing in people with autoimmune rheumatic diseases on immune-lowering treatment

Tests whether yearly tuberculosis re-screening lowers active tuberculosis in people with autoimmune rheumatic diseases.

Plain-language title generated from the registry record
Registry title: Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases

Key facts

Where
São Paulo, BrazilSee the site

Where in Brazil

  • Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SPSão Paulo, BrazilNo longer taking part

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Trial details

Who runs it
University of Sao Paulo General Hospital
Trial code
NCT07731672
Record updated
18 August 2026
Original description
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.Read full original descriptionShow less

Prospective Randomized Controlled Study to Evaluate the Effectiveness of Annual Tuberculosis Re-Screening in Patients With Autoimmune Rheumatic Diseases Receiving Biologic and/or Immunosuppressive Therapy

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.

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

Exclusion: Radiographic evidence suggestive of prior TB; Previous treatment for TBD or TBI; History of tuberculosis infection or disease; Positive baseline TB screening; Follow-up shorter than 12 months.

ClinicalTrials.gov NCT07731672