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

Sponsor:	Ospedale L. Sacco – Polo Universitario
Information provided by:	Ospedale L. Sacco – Polo Universitario
ClinicalTrials.gov Identifier:	NCT00491933

Purpose

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.

Condition	Intervention
Rheumatoid Arthritis Spondylarthritis Tuberculosis	Procedure: Quantiferon-TB Gold assay Procedure: Tuberculin skin test

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis Tuberculosis

Drug Information available for: Tuberculin Purified Protein Derivative

U.S. FDA Resources

Further study details as provided by Ospedale L. Sacco – Polo Universitario:

Primary Outcome Measures:

Concordance between the QFT-G assay and the tuberculin skin test
Correlation of the test results to the patient’s risk of LTBI

Secondary Outcome Measures:

Factors associated with discordance between the TST and the QFT-G test
Frequency of indeterminate results

Estimated Enrollment:	100
Study Start Date:	June 2007
Estimated Study Completion Date:	October 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unable to sign informed consent
Known hypersensitivity to tuberculin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491933

Contacts

Contact: Marco Antivalle, MD	+39023904 ext 2208	marco.antivalle@fastwebnet.it
Contact: Luca Bertani, MD	+39023904 ext 2208	luca-bertani@libero.it

Locations

Italy
Rheumatology Unit, Ospedale L. Sacco Polo Universitario	Recruiting
Milano, Italy, 20157

Sponsors and Collaborators

Ospedale L. Sacco – Polo Universitario

Investigators

Principal Investigator:

Marco Antivalle, MD

Ospedale L. Sacco - Polo Universitario, Milano, Italy

More Information

Publications:

Gomez-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.

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.

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.

Study ID Numbers:	HS-RHEU-2007-001
Study First Received:	June 25, 2007
Last Updated:	June 25, 2007
ClinicalTrials.gov Identifier:	NCT00491933 History of Changes
Health Authority:	Italy: Ethics Committee

Additional relevant MeSH terms:

Spinal Diseases
Bacterial Infections
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases

Actinomycetales Infections
Gram-Positive Bacterial Infections
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Mycobacterium Infections
Tuberculosis
Spondylarthritis

ClinicalTrials.gov processed this record on February 08, 2010