Status:
UNKNOWN
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
Lead Sponsor:
Walter Reed Army Medical Center
Collaborating Sponsors:
National Naval Medical Center
Conditions:
Rheumatoid Arthritis
Tuberculosis
Eligibility:
All Genders
18+ years
Brief Summary
This research will help doctors interested in the usefulness of a new test to discover hidden tuberculosis infections in patients diagnosed with rheumatoid arthritis (RA). This new test is called Quan...
Detailed Description
In recent years the use of biologic agents for the treatment of rheumatic conditions has called into question the utility of the classic tuberculin skin test (TST) for the diagnosis of latent tubercul...
Eligibility Criteria
Inclusion
- Study group:
- Any patient 18 years or older who has been diagnosed with RA (American College of Rheumatology (ACR) criteria) and is being considered for de novo anti-TNF alpha therapy will be invited to participate in this study.
- Control group:
- Control subjects will be any patient 18 years or older presenting to the Allergy/Immunology clinic for routine TST.
Exclusion
- Study group:
- We will exclude any individual with a previous history of known immuno-compromising disease state or unstable medical condition other than RA resulting in overall poor health and/or protein calorie deprivation to include:
- any other autoimmune disease
- oral steroid use in the past 3 days (4 half-lives of prednisone is 14 hours)
- inhaled steroid use at a dose of \> 2000 mg beclomethasone equivalent/day
- any cancer \[solid organ or blood\]
- radiation therapy in prior three months
- any bleeding disorders
- chemotherapeutic agents
- transfusion or blood products in past 1 year
- history of HIV
- chronic hepatitis
- malignancy
- transplant history
- chronic infection
- chronic renal failure
- current allergy treatment (shots, antihistamines)
- uncontrolled diabetes, or the inability to provide informed consent
- we will also exclude individuals with immediate hypersensitivity to the TST/PPD or PHA antigens
- a previous severe local ulceration with TST/PPD
- suspected active TB, previous TB treatment
- Control group:
- We will exclude any individual with known history of anti-TNF alpha therapy.
- We will also exclude any patient with a history of any immune-modulatory (DMARD) therapy (steroids, anti-TNF agents, methotrexate, azathioprine, sulfasalazine, etc.) within the previous 12 months.
- Additionally we will exclude all those individuals with previous history of TB or TB therapy, diabetes mellitus, HIV, malignancy, or hepatitis that may influence the dermal reaction to PHA antigen or ex vivo CMI activity.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00925249
Start Date
May 1 2009
End Date
June 1 2011
Last Update
December 14 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307