An interventional study of re-screening and No Rescreening in Autoimmune Rheumatic Diseases and Prevention, sponsored by University of Sao Paulo General Hospital. Not yet recruiting at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Prevention
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.
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 1,660 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Routine annual TB re-screening after negative (IGRA)
Standard clinical follow-up without routine annual TB re-screening
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
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
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
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
Adverse Events Related to TBI Treatment
Frequency of drug-related adverse events (e.g., hepatotoxicity)
Time frame: Up to 48 months
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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