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NCT Number: NCT07731672

Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases

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.

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Key information

Conditions

Autoimmune Rheumatic Diseases Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Prevention Tuberculosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP

São Paulo, 01246-903, Brazil

Location contact

Eloisa SDO Bonfa, Full Professor

CONTACT

[email protected]

+55 11 2661-8806

About this study

Tuberculosis remains highly prevalent in endemic countries such as Brazil. Patients with autoimmune rheumatic diseases (ARDs) receiving immunosuppressive therapies, particularly biologic agents, are at increased risk of progression from tuberculosis infection (TBI) to tuberculosis disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

re-screening

Other

Routine annual TB re-screening after negative (IGRA)

No Rescreening

Other

Standard clinical follow-up without routine annual TB re-screening

Primary outcomes

  1. Incidence of Tuberculosis Disease

    Time frame: Up to 48 months

    Number of confirmed TBD cases during the follow-up period among patients with autoimmune rheumatic diseases using biologic and/or Immunosuppressive therapy.

Secondary outcomes

  1. Risk Factors for TBD Development

    Time frame: Up to 48 months

    Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use)

  2. Rate of TBI Conversion

    Time frame: Up to 36 months

    Proportion of patients converting from negative to positive IGRA during follow-up

  3. Risk Factors for TBI Development

    Time frame: Up to 36 months

    Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use)

  4. Effect of TBI Treatment on TB Incidence

    Time frame: Up to 48 months

    Proportion of patients converting from negative to positive IGRA during follow-up

  5. Adverse Events Related to TBI Treatment

    Time frame: Up to 48 months

    Frequency of drug-related adverse events (e.g., hepatotoxicity)

Study contacts

Contact information is provided by the study sponsor or research team.

Eloisa SDO Bonfa, Full Professor

CONTACT

[email protected]

+55 11 3061-7490

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Acronym: TB-RESCREEN

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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