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

June 25, 2007 updated by: ASST Fatebenefratelli Sacco

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20157
        • Recruiting
        • Rheumatology Unit, Ospedale L. Sacco Polo Universitario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Factors associated with discordance between the TST and the QFT-G test
Frequency of indeterminate results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Fatebenefratelli Sacco

Investigators

  • Principal Investigator: Marco Antivalle, MD, Ospedale L. Sacco - Polo Universitario, Milano, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion (ANTICIPATED)

October 1, 2007

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (ESTIMATE)

June 26, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2007

Last Update Submitted That Met QC Criteria

June 25, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-RHEU-2007-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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