Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Sao Paulo General Hospital

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

1,660 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Sao Paulo General Hospital

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator