Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases (TB-RESCREEN)
14. august 2026 opdateret af: University of Sao Paulo General Hospital
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
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1660
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Eloisa SDO Bonfa, Full Professor
- Telefonnummer: +55 11 3061-7490
- E-mail: reumatologia.fmusp@hc.fm.usp.br
Studiesteder
-
-
São Paulo
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São Paulo, São Paulo, Brasilien, 01246-903
- Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP
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Kontakt:
- Eloisa SDO Bonfa, Full Professor
- Telefonnummer: +55 11 2661-8806
- E-mail: reumatologia.fmusp@hc.fm.usp.br
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Annual IGRA Rescreening
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. |
Routine annual TB re-screening after negative (IGRA)
|
|
Andet: 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.
|
Standard clinical follow-up without routine annual TB re-screening
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Tuberculosis Disease
Tidsramme: 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).
|
Up to 48 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse Events Related to TBI Treatment
Tidsramme: Up to 48 months
|
Frequency of drug-related adverse events (e.g., hepatotoxicity)
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Up to 48 months
|
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Risk Factors for TBD Development
Tidsramme: Up to 48 months
|
Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) for TBD development.
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Up to 48 months
|
|
Rate of TBI Conversion
Tidsramme: Up to 36 months
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Proportion of patients converting from negative to positive IGRA during follow-up in the "annual IGRA rescreening group" (interventional arm).
|
Up to 36 months
|
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Risk Factors for TBI Conversion
Tidsramme: 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).
|
Up to 36 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
30. juli 2030
Studieafslutning (Anslået)
30. juli 2031
Datoer for studieregistrering
Først indsendt
22. juli 2026
Først indsendt, der opfyldte QC-kriterier
22. juli 2026
Først opslået (Faktiske)
28. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 77212824.0.0000.0068
Plan for individuelle deltagerdata (IPD)
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