Quantiferon-TB Gold in the Assessment of Latent TB in Patients Candidate to Treatment or Treated With TNFα Antagonists (TNFTB)
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|ClinicalTrials.gov Identifier: NCT00491933|
Recruitment Status : Unknown
Verified June 2007 by ASST Fatebenefratelli Sacco.
Recruitment status was: Recruiting
First Posted : June 26, 2007
Last Update Posted : June 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Spondylarthritis Tuberculosis||Procedure: Quantiferon-TB Gold assay Procedure: Tuberculin skin test||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2007|
|Estimated Study Completion Date :||October 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491933
|Contact: Marco Antivalle, MD||+39023904 ext email@example.com|
|Contact: Luca Bertani, MD||+39023904 ext firstname.lastname@example.org|
|Rheumatology Unit, Ospedale L. Sacco Polo Universitario||Recruiting|
|Milano, Italy, 20157|
|Principal Investigator:||Marco Antivalle, MD||Ospedale L. Sacco - Polo Universitario, Milano, Italy|