NCT07731672Not yet recruiting
Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases
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
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1660 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 30 Jul 2030
- Lead sponsor
- University of Sao Paulo General Hospital
- Diseases
- Tuberculosis
- NCT number
- NCT07731672
What you commit to
- Study type: Interventional
- Planned participants: 1660
- From 1 Aug 2026 to the primary completion date, 30 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiographic evidence suggestive of prior TB
- Previous treatment for TBD or TBI
Other illness
- History of tuberculosis infection or disease
Other
- Positive baseline TB screening;
- Follow-up shorter than 12 months
Who the study is looking for
- Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria
- negative baseline screening for tuberculosis infection.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.