About this trial
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.
Eligibility criteria
Qualifiers
Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria
negative baseline screening for tuberculosis infection.
Disqualifiers
History of tuberculosis infection or disease
Radiographic evidence suggestive of prior TB
Previous treatment for TBD or TBI
Positive baseline TB screening;
Trial design
Treatments tested in this trial
- re-screening
- No Rescreening
Treatment groups
Sponsors and collaborators
University of Sao Paulo General Hospital
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator