An interventional study of Quantiferon-TB Gold assay and Tuberculin skin test in Rheumatoid Arthritis, Spondylarthritis and Tuberculosis, sponsored by ASST Fatebenefratelli Sacco. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-06-26.
Sponsored by ASST Fatebenefratelli Sacco · Not applicable, Interventional, and Diagnostic
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.
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →ASST Fatebenefratelli Sacco is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Concordance between the QFT-G assay and the tuberculin skin test
Correlation of the test results to the patient's risk of LTBI
Factors associated with discordance between the TST and the QFT-G test
Frequency of indeterminate results
This study is status unknown, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.
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ASST Fatebenefratelli Sacco