Recruiting

TST vs. QFT-G

Sponsor:

Walter Reed Army Medical Center

Code:

NCT00925249

Conditions

Rheumatoid Arthritis

Tuberculosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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 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.

Conditions

Rheumatoid Arthritis

Tuberculosis

Study ID

NCT00925249

Start date

May, 2009

Status verified date

Jun, 2009

Completion date

Jun, 2011

Anticipated

Primary completion date

May, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

1

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.

2

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 outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Robert O Holmes, DO

202-782-6735robertoholmes@hotmail.com

Adam T Armstrong, DO

202-782-6734david.t.armstrong@us.army.mil

Locations

Walter Reed Army Medical Center

Recruiting

Washington, District of Columbia, United States, 20307

Contacts

Adam T Armstrong, DO

202-782-6734david.t.armstrong@us.army.mil

Peter Henning, DO

202-782-6734peter.henning1@us.army.mil

Principal Investigator:

Adam T Armstrong, DO

More Information

Sponsor

Walter Reed Army Medical Center

Last update posted

Dec 14, 2009

Last verified

Jun, 2009

Keywords

  • rheumatoid arthritis
  • RA
  • TB
  • tuberculosis
  • anti-TNF therapy
  • biologic therapy
  • quantiferon
  • IGRA
  • Newly diagnosed rheumatoid arthritis (RA) in the Tricare system

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed Army Medical Center on 2009-12-14.