Quantiferon-TB Gold in the Assessment of Latent TB in Patients Candidate to Treatment or Treated With TNFα Antagonists (TNFTB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Ospedale L. Sacco – Polo Universitario.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ospedale L. Sacco – Polo Universitario
ClinicalTrials.gov Identifier:
NCT00491933
First received: June 25, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

The purpose of this study is to evaluate the value of Quantiferon-TB Gold (QFT-G) assay in the screening for latent tuberculosis infection (LTBI) in rheumatologic patients due to start or on treatment with TNFα antagonists. The results of QFT-G will be compared to tuberculin skin testing (TST) and correlated to clinical and demographic data. The study hypothesis is that the inclusion of QTF-G in the screening strategy will allow a more accurate assessment of LTBI infection.


Condition Intervention
Rheumatoid Arthritis
Spondylarthritis
Tuberculosis
Procedure: Quantiferon-TB Gold assay
Procedure: Tuberculin skin test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in the Assessment of Latent Mycobacterium Tuberculosis Infection in Patients Candidate to Treatment or Treated With TNFα Antagonists

Resource links provided by NLM:


Further study details as provided by Ospedale L. Sacco – Polo Universitario:

Primary Outcome Measures:
  • Concordance between the QFT-G assay and the tuberculin skin test
  • Correlation of the test results to the patient’s risk of LTBI

Secondary Outcome Measures:
  • Factors associated with discordance between the TST and the QFT-G test
  • Frequency of indeterminate results

Estimated Enrollment: 100
Study Start Date: June 2007
Estimated Study Completion Date: October 2007
Detailed Description:

Treatment with TNFα antagonists is associated with an increased risk of active tuberculosis. Screening for LTBI and adherence to published guidelines have been shown to greatly decrease the risk of active tuberculosis. However, the best screening strategy is still object of debate. The validity of TST in patients on immunosuppressive treatment has been questioned. Recently, interferon-γ assays based on RD1-specific antigens have shown to cause less confounding by BCG vaccination and from most non-tuberculosis mycobacteria than TST, and have shown improved accuracy over TST in several settings. However, data on their use in rheumatologic patients are limited, and their superiority in patients on immunosuppressive treatment is unclear since indeterminate results may limit their clinical usefulness in this setting.

Purpose of the study is to investigate the added value of the inclusion of QTF-G assay in the screening strategy of LTBI in rheumatologic patients before and during treatment with TNFα antagonists.

The study will compare the results of TST with the results of QFT-G assay in rheumatologic patients being evaluated for treatment with anti-TNFα agents or already on treatment with anti-TNFα agents. The rate of positive and negative results of the two test will be compared, end results correlated to clinical and demographic variables.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with rheumatological diseases being evaluated for treatment with TNFα antagonists or on treated with TNFα antagonists

Exclusion Criteria:

  • Unable to sign informed consent
  • Known hypersensitivity to tuberculin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491933

Contacts
Contact: Marco Antivalle, MD +39023904 ext 2208 marco.antivalle@fastwebnet.it
Contact: Luca Bertani, MD +39023904 ext 2208 luca-bertani@libero.it

Locations
Italy
Rheumatology Unit, Ospedale L. Sacco Polo Universitario Recruiting
Milano, Italy, 20157
Sponsors and Collaborators
Ospedale L. Sacco – Polo Universitario
Investigators
Principal Investigator: Marco Antivalle, MD Ospedale L. Sacco - Polo Universitario, Milano, Italy
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00491933     History of Changes
Other Study ID Numbers: HS-RHEU-2007-001
Study First Received: June 25, 2007
Last Updated: June 25, 2007
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Spondylarthritis
Tuberculosis
Actinomycetales Infections
Arthritis
Autoimmune Diseases
Bacterial Infections
Bone Diseases
Connective Tissue Diseases
Gram-Positive Bacterial Infections
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Mycobacterium Infections
Rheumatic Diseases
Spinal Diseases
Spondylitis

ClinicalTrials.gov processed this record on October 22, 2014