Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases | NCT07731672

NCT07731672

Overview

NCT ID: NCT07731672
Lead Sponsor: University of Sao Paulo General HospitalOTHER
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
Brief 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.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Jul 30, 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria

negative baseline screening for tuberculosis infection.

Exclusion Criteria:

History of tuberculosis infection or disease

Radiographic evidence suggestive of prior TB

Previous treatment for TBD or TBI

Positive baseline TB screening;

Follow-up shorter than 12 months

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 1,660Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Eloisa SDO Bonfa, Full ProfessorContact
reumatologia.fmusp@hc.fm.usp.br

Similar Studies

Participant Group/Arms

Annual IGRA RescreeningExperimental

Patients will undergo repeated IGRA annually for 3 years after an initial negative screening. Baseline screening includes epidemiologic questionnaire, chest X-ray and interferon-gamma release assay (IGRA). Patients with new positive results will be investigated (chest X ray and clinical synthons) for TBD. If negative, they will receive TBI indicated treatment.

Other: re-screening

No RescreeningOther

Patients will not repeat annual TB screening after the baseline negative evaluation (except in cases before the initiation of advanced therapy). They will continue standard clinical follow-up and monitoring for TBD symptoms.

Other: No Rescreening