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Not yet recruiting NCT07731672

Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases

No phase Interventional Autoimmune Rheumatic Diseases Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: re-screening, No Rescreening.
Who it may be relevant to
Registry conditions: Autoimmune Rheumatic Diseases, Prevention. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Other re-screening
    Routine annual TB re-screening after negative (IGRA)
  • Other No Rescreening
    Standard clinical follow-up without routine annual TB re-screening

Primary outcome measures

  • Incidence of Tuberculosis Disease [Time frame: Up to 48 months]
Secondary outcome measures (5)
  • Risk Factors for TBD Development [Time frame: Up to 48 months]
  • Rate of TBI Conversion [Time frame: Up to 36 months]
  • Risk Factors for TBI Development [Time frame: Up to 36 months]
  • Effect of TBI Treatment on TB Incidence [Time frame: Up to 48 months]
  • Adverse Events Related to TBI Treatment [Time frame: Up to 48 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Brazil · 1 center
  • Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP — São Paulo

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 G 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. Europ PMID 26644232

Identifiers

NCT: NCT07731672 · 77212824.0.0000.0068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗