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Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases
Sponsor: University of Sao Paulo General Hospital
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
Conditions
Interventions
re-screening
Routine annual TB re-screening after negative (IGRA)
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