Quantiferon-TB Gold in the Assessment of Latent TB in Patients Candidate to Treatment or Treated With TNFα Antagonists

Rheumatoid Arthritis Clinical Trial

— TNFTB  

Official title:

Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in the Assessment of Latent Mycobacterium Tuberculosis Infection in Patients Candidate to Treatment or Treated With TNFα Antagonists

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00491933
• Other study ID #: HS-RHEU-2007-001
• Status: Recruiting
• Phase: N/A
• First received: June 25, 2007
• Last updated: June 25, 2007
• Start date: June 2007
• Est. completion date: October 2007

Study information

• Verified date: June 2007
• Source: Ospedale L. Sacco – Polo Universitario
• Contact: Marco Antivalle, MD
• Phone: +39023904
• Email: marco.antivalle[@]fastwebnet.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the value of Quantiferon-TB Gold (QFT-G) assay in the screening for latent tuberculosis infection (LTBI) in rheumatologic patients due to start or on treatment with TNFα antagonists. The results of QFT-G will be compared to tuberculin skin testing (TST) and correlated to clinical and demographic data. The study hypothesis is that the inclusion of QTF-G in the screening strategy will allow a more accurate assessment of LTBI infection.

Description:

Treatment with TNFα antagonists is associated with an increased risk of active tuberculosis. Screening for LTBI and adherence to published guidelines have been shown to greatly decrease the risk of active tuberculosis. However, the best screening strategy is still object of debate. The validity of TST in patients on immunosuppressive treatment has been questioned. Recently, interferon-γ assays based on RD1-specific antigens have shown to cause less confounding by BCG vaccination and from most non-tuberculosis mycobacteria than TST, and have shown improved accuracy over TST in several settings. However, data on their use in rheumatologic patients are limited, and their superiority in patients on immunosuppressive treatment is unclear since indeterminate results may limit their clinical usefulness in this setting.

Purpose of the study is to investigate the added value of the inclusion of QTF-G assay in the screening strategy of LTBI in rheumatologic patients before and during treatment with TNFα antagonists.

The study will compare the results of TST with the results of QFT-G assay in rheumatologic patients being evaluated for treatment with anti-TNFα agents or already on treatment with anti-TNFα agents. The rate of positive and negative results of the two test will be compared, end results correlated to clinical and demographic variables.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with rheumatological diseases being evaluated for treatment with TNFa antagonists or on treated with TNFa antagonists

Exclusion Criteria:

• Unable to sign informed consent

• Known hypersensitivity to tuberculin

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Spondylarthritis
• Tuberculosis

Intervention

Procedure:
• Quantiferon-TB Gold assay

• Tuberculin skin test

Locations

Country	Name	City	State
Italy	Rheumatology Unit, Ospedale L. Sacco Polo Universitario	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale L. Sacco – Polo Universitario

Country where clinical trial is conducted

Italy, 

References & Publications (3)

British Thoracic Society Standards of Care Committee. BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF-alpha treatment. Thorax. 2005 Oct;60(10):800-5. Epub 2005 Jul 29. Review. — View Citation

Ferrara G, Losi M, Meacci M, Meccugni B, Piro R, Roversi P, Bergamini BM, D'Amico R, Marchegiano P, Rumpianesi F, Fabbri LM, Richeldi L. Routine hospital use of a new commercial whole blood interferon-gamma assay for the diagnosis of tuberculosis infection. Am J Respir Crit Care Med. 2005 Sep 1;172(5):631-5. Epub 2005 Jun 16. — View Citation

Gómez-Reino JJ, Carmona L, Valverde VR, Mola EM, Montero MD; BIOBADASER Group. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum. 2003 Aug;48(8):2122-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between the QFT-G assay and the tuberculin skin test
Primary	Correlation of the test results to the patient’s risk of LTBI
Secondary	Factors associated with discordance between the TST and the QFT-G test
Secondary	Frequency of indeterminate results