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
| Registry | NCT07731672, acronym TB-RESCREEN |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, prevention |
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| Enrollment | 1660 (Estimated) |
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| Sponsor | University of Sao Paulo General Hospital (Other); collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo |
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| Conditions | Autoimmune Rheumatic Diseases, Prevention |
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| Interventions | re-screening, No Rescreening (Other) |
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| Dates | start 2026-08-01 (estimated), primary completion 2030-07-30 (estimated), completion 2031-07-30 (estimated), first posted 2026-07-28, last updated 2026-08-18 |
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| Locations | 1 site in Brazil |
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-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.
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+Detailed description
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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Annual IGRA Rescreening | Experimental | Other: re-screening | 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. |
| No Rescreening | Other | Other: No Rescreening | 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. |
- re-screening (Other): Routine annual TB re-screening after negative (IGRA)
- No Rescreening (Other): Standard clinical follow-up without routine annual TB re-screening
+Outcome measures
Primary outcomes
- Incidence of Tuberculosis Disease [Up to 48 months]: 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).
Secondary outcomes
- Risk Factors for TBD Development [Up to 48 months]: Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) for TBD development.
- Rate of TBI Conversion [Up to 36 months]: Proportion of patients converting from negative to positive IGRA during follow-up in the "annual IGRA rescreening group" (interventional arm).
- Risk Factors for TBI Conversion [Up to 36 months]: Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) in the "annual IGRA rescreening group" (interventional arm).
- Adverse Events Related to TBI Treatment [Up to 48 months]: Frequency of drug-related adverse events (e.g., hepatotoxicity)
+Eligibility
Sex: All
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
+Locations (1)
| Facility | City | Country | Status |
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| Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP | São Paulo, São Paulo | Brazil | |
+Publications
- Bonfiglioli KR, Ribeiro AC, Moraes JC, Saad CG, Souza FH, Calich AL, Bonfa E, Laurindo IM. LTBI screening in rheumatoid arthritis patients prior to anti-TNF treatment in an endemic area. Int J Tuberc Lung Dis. 2014 Aug;18(8):905-11. doi: 10.5588/ijtld.13.0755. PMID 25199003
- Yonekura CL, Oliveira RDR, Titton DC, Ranza R, Ranzolin A, Hayata AL, Duarte A, Silveira IG, Carvalho HMDS, Moraes JCB, Abreu MM, Valim V, Bianchi W, Brenol CV, Pereira IA, Costa I, Macieira JC, Miranda JRS, Guedes-Barbosa LS, Bertolo MB, Sauma MFLDC, Silva MBG, Freire M, Scheinberg MA, Toledo RA, Oliveira SKF, Fernandes V, Pinheiro MM, Castro G, Vieira WP, Baaklini CE, Ruffino-Netto A, Pinheiro GDRC, Laurindo IMM, Louzada-Junior P. Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoracao de Terapias Biologicas - BiobadaBrasil). Rev Bras Reumatol Engl Ed. 2017;57 Suppl 2:477-483. doi: 10.1016/j.rbre.2017.05.005. Epub 2017 Jul 22. English, Portuguese. PMID 28739353
- Brunelli JB, Bonfiglioli KR, Silva CA, Kozu KT, Goldenstein-Schainberg C, Bonfa E, Aikawa NE. Latent tuberculosis infection screening in juvenile idiopathic arthritis patients preceding anti-TNF therapy in a tuberculosis high-risk country. Rev Bras Reumatol Engl Ed. 2017 Sep-Oct;57(5):392-396. doi: 10.1016/j.rbre.2016.11.004. Epub 2016 Dec 7. English, Portuguese. PMID 29037310
- Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewe R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Canete JD, Damjanov N, FitzGerald O, Haglund E, Helliwell P, Kvien TK, Lories R, Luger T, Maccarone M, Marzo-Ortega H, McGonagle D, McInnes IB, Olivieri I, Pavelka K, Schett G, Sieper J, van den Bosch F, Veale DJ, Wollenhaupt J, Zink A, van der Heijde D. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Mar;75(3):499-510. doi: 10.1136/annrheumdis-2015-208337. Epub 2015 Dec 7. PMID 26644232