NCT07731672

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,660

participants targeted

Target at P75+ for not_applicable

Timeline
61mo left

Started Aug 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2031

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

4 years

First QC Date

July 22, 2026

Last Update Submit

July 29, 2026

Conditions

Autoimmune Rheumatic DiseasesPrevention

Keywords

TuberculosisTuberculosis diseaseTuberculosis infectionAutoimmune Rheumatic DiseasesBiologic TherapyScreeningIGRARheumatologyPreventionProspective Study

Outcome Measures

Primary Outcomes (1)

  • Incidence of Tuberculosis Disease

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

    Up to 48 months

Secondary Outcomes (5)

  • Risk Factors for TBD Development

    Up to 48 months

  • Rate of TBI Conversion

    Up to 36 months

  • Risk Factors for TBI Development

    Up to 36 months

  • Effect of TBI Treatment on TB Incidence

    Up to 48 months

  • Adverse Events Related to TBI Treatment

    Up to 48 months

Study Arms (2)

Annual IGRA Rescreening

EXPERIMENTAL

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

No Rescreening

OTHER

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

Interventions

re-screeningOTHER

Routine annual TB re-screening after negative (IGRA)

Annual IGRA Rescreening
No RescreeningOTHER

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

No Rescreening

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria
  • negative baseline screening for tuberculosis infection.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 01246-903, Brazil

Location

Related Publications (4)

  • 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: 25199003BACKGROUND

  • 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: 28739353BACKGROUND

  • 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: 29037310BACKGROUND

  • 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: 26644232BACKGROUND

MeSH Terms

Conditions

TuberculosisLatent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Central Study Contacts

Eloisa SDO Bonfa, Full Professor

CONTACT

+55 11 3061-7490reumatologia.fmusp@hc.fm.usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 28, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 30, 2030

Study Completion (Estimated)

July 30, 2031

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)