[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

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Study’s contact

Call center

202-782-6735

Email address

robertoholmes@hotmail.com

Condition

Rheumatoid Arthritis,Tuberculosis

Treatment type

Observational

Phase

N/A

Sponsor

Walter Reed Army Medical Center

ClinicalTrials.gov identifier

NCT00925249

Study number

6950

Date first posted

May 13, 2009

Date last update

December 11, 2009

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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.

Who can take part?

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

Inclusion criteria
  1. ACR)
  2. 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
  1. 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,
  2. 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 (
  3. 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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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