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Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases

ConditionsAutoimmune Rheumatic DiseasesPrevention
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • re-screening

    Other intervention

    Routine annual TB re-screening after negative (IGRA)

  • No Rescreening

    Other intervention

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

Treatment groups

1,660 Participants
are divided into 2 treatment groups
Group A: Annual IGRA RescreeningExperimental treatment 1 intervention
Group B: No RescreeningOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Tuberculosis Disease

Incidence of confirmed TBD cases during the follow-up period among patients with autoimmune rheumatic diseases using biologic and/or Immunosuppressive therapy in both arms: "annual IGRA rescreening" (intervention arm) and "no rescreening" (standard clinical follow-up).

Time frame
Up to 48 months

Secondary outcomes

1

Risk Factors for TBD Development

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

Time frame
Up to 48 months
2

Rate of TBI Conversion

Proportion of patients converting from negative to positive IGRA during follow-up in the "annual IGRA rescreening group" (interventional arm).

Time frame
Up to 36 months
3

Risk Factors for TBI Conversion

Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) in the "annual IGRA rescreening group" (interventional arm).

Time frame
Up to 36 months
4

Adverse Events Related to TBI Treatment

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

Time frame
Up to 48 months

Other outcomes

Sponsors and contacts

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University of Sao Paulo General Hospital

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: