Comparison of the Tuberculin Skin Test (TST) and QuantiFERON ®-TB Gold Test (QFT-G) In Patients With Rheumatoid Arthritis Being Considered for Anti-TNF-Alpha Therapy
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|ClinicalTrials.gov Identifier: NCT00925249|
Recruitment Status : Unknown
Verified June 2009 by Walter Reed Army Medical Center.
Recruitment status was: Recruiting
First Posted : June 22, 2009
Last Update Posted : December 14, 2009
|Condition or disease|
|Rheumatoid Arthritis Tuberculosis|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||Comparison of the Tuberculin Skin Test (TST) and QuantiFERON ®-TB Gold Test (QFT-G) In Patients With Rheumatoid Arthritis Being Considered for Anti-TNF-Alpha Therapy|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||June 2011|
The study group will consist of RA patients of the Walter Reed Army Medical Center (WRAMC) rheumatology clinic being considered for treatment with anti-TNF alpha therapy. We will enter patients into the study over a projected course of 12-24 months or until we reach the statistical requirement of 60 subjects.
The control group will consist of healthy subjects without known immune-dysregulation or history of treatment with biologic agents who present to the WRAMC Allergy- Immunology clinic for routine screening TST as a part of current WRAMC policy.
- Primary endpoints are the results of the QFT-G test (defined as positive, negative or indeterminate) and the results of the TST (defined as positive or negative). [ Time Frame: Patients will be enrolled over a 2 year time frame ]
- Secondary endpoints include the percentage and numbers of CD45RO (memory T cells), the response PHA intradermal antigen placement, numbers of hypoergic TSTs, and the results of cell mediated immunity (CMI) assays. [ Time Frame: Patients will be enrolled over a 2 year time period ]
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): NCT00925249
|Contact: Robert O Holmes, DOfirstname.lastname@example.org|
|Contact: Adam T Armstrong, DOemail@example.com|
|United States, District of Columbia|
|Walter Reed Army Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20307|
|Contact: Adam T Armstrong, DO 202-782-6734 firstname.lastname@example.org|
|Contact: Peter Henning, DO 202-782-6734 email@example.com|
|Principal Investigator: Adam T Armstrong, DO|
|Principal Investigator: Robert O Holmes, DO|
|Principal Investigator:||Adam T Armstrong, DO||Rheumatology Fellow - Walter Reed Army Medical Center|
|Study Chair:||Robert O Holmes, DO||National Naval Medical Center|