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NOT YET RECRUITING
NCT07731672
NA

Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases

Sponsor: University of Sao Paulo General Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1660

Start Date

2026-08-01

Completion Date

2031-07-30

Last Updated

2026-07-28

Healthy Volunteers

No

Interventions

OTHER

re-screening

Routine annual TB re-screening after negative (IGRA)

OTHER

No Rescreening

Standard clinical follow-up without routine annual TB re-screening

Locations (1)

Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP

São Paulo, São Paulo, Brazil