For Healthcare Professionals

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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About the study

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 Quantiferon-Gold (QFT-G). After immune system medicines that block TNF-alpha (a protein manufactured by white blood cells to stimulate and activate the immune system in response to infection or cancer) started to be used, the rate of tuberculosis infections in patients treated with these medicines has increased. Doctors think that the investigators may be missing some tuberculosis infections that were hidden before the medicine is started. This new QFT-G test might better diagnose these hidden tuberculosis infections than the current tuberculosis skin test, also known as a PPD/TST. The investigators would like to compare these two tests to find out which is better at detecting these hidden infections. At the same time the investigators will measure the strength of the patient's immune system with a blood test. If you are being considered for a TNF-alpha inhibitor medicine, or are getting the patient's routine PPD/TST, the investigators are asking for the patient's participation.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Study group:

  1. 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:
  2. Control subjects will be any patient 18 years or older presenting to the Allergy/Immunology clinic for routine TST.

EXCLUSION CRITERIA

Study group:

  1. 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:
  2. any other autoimmune disease
  3. oral steroid use in the past 3 days (4 half-lives of prednisone is 14 hours)
  4. inhaled steroid use at a dose of > 2000 mg beclomethasone equivalent/day
  5. any cancer [solid organ or blood]
  6. radiation therapy in prior three months
  7. any bleeding disorders
  8. chemotherapeutic agents
  9. transfusion or blood products in past 1 year
  10. history of HIV
  11. chronic hepatitis
  12. malignancy
  13. transplant history
  14. chronic infection
  15. chronic renal failure
  16. current allergy treatment (shots, antihistamines)
  17. uncontrolled diabetes, or the inability to provide informed consent
  18. we will also exclude individuals with immediate hypersensitivity to the TST/PPD or PHA antigens
  19. a previous severe local ulceration with TST/PPD
  20. suspected active TB, previous TB treatment Control group:
  21. We will exclude any individual with known history of anti-TNF alpha therapy.
  22. 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.
  23. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 202-782-6735Email iconEmail Study Center

Study’s details


Contition

Rheumatoid Arthritis,Tuberculosis

Age (in years)

18 - 200

Phase

N/A

Participants needed

90

Est. Completion Date

Jun 2011

Treatment type

Observational


Sponsor

Walter Reed Army Medical Center

ClinicalTrials.gov identifier

NCT00925249

Study number

6950

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