Rheumatoid Arthritis Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 Criteria: 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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Walter Reed Army Medical Center | National Naval Medical Center |
United States,
British Thoracic Society Standards of Care Committee. BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF-alpha treatment. Thorax. 2005 Oct;60(10):800-5. Epub 2005 Jul 29. Review. — View Citation
Carmona L, Gómez-Reino JJ, Rodríguez-Valverde V, Montero D, Pascual-Gómez E, Mola EM, Carreño L, Figueroa M; BIOBADASER Group. Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists. Arthritis Rheum. 2005 Jun;52(6):1766-72. — View Citation
Chen DY, Shen GH, Hsieh TY, Hsieh CW, Lan JL. Effectiveness of the combination of a whole-blood interferon-gamma assay and the tuberculin skin test in detecting latent tuberculosis infection in rheumatoid arthritis patients receiving adalimumab therapy. Arthritis Rheum. 2008 Jun 15;59(6):800-6. doi: 10.1002/art.23705. — View Citation
D. Mines, Y. Gu, Q. Liu, L.N. Horne, M.J. Harrison. Global Safety Surveillance and Epidemiology. Wyeth Research, Collegeville, United States. [2008][OP-0138] Risk of Active Tuberculosis (TB) Among Biologic-Naïve RA Patients Retrospective Cohor Study in a US Claims Database. Ann Rheum Dis 2008;67(Suppl II):91.
Gómez-Reino JJ, Carmona L, Valverde VR, Mola EM, Montero MD; BIOBADASER Group. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum. 2003 Aug;48(8):2122-7. — View Citation
Greenberg JD, Reddy SM, Schloss SG, Kurucz OS, Bartlett SJ, Abramson SB, Bingham CO 3rd. Comparison of an in vitro tuberculosis interferon-gamma assay with delayed-type hypersensitivity testing for detection of latent Mycobacterium tuberculosis: a pilot study in rheumatoid arthritis. J Rheumatol. 2008 May;35(5):770-5. Erratum in: J Rheumatol. 2008 May;35(5):943. — View Citation
Matulis G, Jüni P, Villiger PM, Gadola SD. Detection of latent tuberculosis in immunosuppressed patients with autoimmune diseases: performance of a Mycobacterium tuberculosis antigen-specific interferon gamma assay. Ann Rheum Dis. 2008 Jan;67(1):84-90. Epub 2007 Jul 20. — View Citation
Ponce de León D, Acevedo-Vásquez E, Sánchez-Torres A, Cucho M, Alfaro J, Perich R, Pastor C, Harrison J, Sánchez-Schwartz C. Attenuated response to purified protein derivative in patients with rheumatoid arthritis: study in a population with a high prevalence of tuberculosis. Ann Rheum Dis. 2005 Sep;64(9):1360-1. — View Citation
Takahashi H, Shigehara K, Yamamoto M, Suzuki C, Naishiro Y, Tamura Y, Hirohashi Y, Satoh N, Shijubo N, Shinomura Y, Imai K. Interferon gamma assay for detecting latent tuberculosis infection in rheumatoid arthritis patients during infliximab administration. Rheumatol Int. 2007 Oct;27(12):1143-8. Epub 2007 May 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Patients will be enrolled over a 2 year time frame | No | |
Secondary | 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. | Patients will be enrolled over a 2 year time period | No |
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