Impact of New Immunological Diagnosis Tests of Latent Tuberculosis Before Anti TNF Therapy (ETAT)

January 6, 2014 updated by: Assistance Publique - Hôpitaux de Paris

Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.

Tuberculosis is a current infection during anti TNF therapy. After infectious contact, some patients will develop tuberculosis and some will only be infected without symptoms, they have Latent Tuberculosis Infection (LTBI) wich can reactivate later. In order to prevent this tuberculosis reactivation, LTBI diagnosis screening is preconised in patients who need anti TNF therapy. This diagnosis is made till now by the tuberculin skin test (TST) but this test is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific to MTB infection are now available.

The primary endpoint of this study is the evaluation of the theoric therapeutic impact of the use of new tests for diagnosis of LTBI in patients before anti TBF therapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed description :

Principal outcome: Therapeutic impact of the use of new tests for diagnosis of LTBI in patients before anti TBF therapy

Secondary outcomes :

  • medico-economic impact of replacement of TST by QFTB-G and T-SPOT.TB tests in LTBI screening in patients before anti TNF therapy.
  • concordance of QFTB-G and T-SPOT.TB tests results with TST
  • Concordance between QFTB-G and T-SPOT.TB tests and evaluation of indetermined tests.
  • concordance of QFTB-G and T-SPOT.TB tests results with patient disease.
  • concordance of QFTB-G and T-SPOT.TB tests results with TST in patients with LTBI determinated by clinical or radiological observation
  • Impact of geographical, disease and treatment in patients with LTBI determinated by clinical or radiological observation
  • Identify the original characteristic and maximal impact therapeutic of QFTB-G and T-SPOT.TB test

Analysed criteria :

  • therapeutic impact
  • Patients percentage with different therapeutic outcome based on usual recommendations medico-economic
  • Medico-economic impact :impact of both tests as early and late cost - efficacy

Statistic :

  • Primary criteria : Percentage of patients for whom therapeutic would have been changed by QFTB-G and T-SPOT.TB tests results compared to usual diagnosis strategy.

  • Secondary criteria : Concordance of QFTB-G and T-SPOT.TB tests with TST Concordance between both QFTB-G and T-SPOT.TB tests .

    400 patients Timing : inclusions : 1 years

Study Type

Interventional

Enrollment (Actual)

430

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

  • France
      • Le Kremlin Bicêtre, France, 94275
        • Bicêtre Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years old
  • Patient with rheumatoid arthritis or Ankylosing spondylitis or Crohn's disease
  • Patient without Anti TNF treatment and who need one by infliximab, adalimumab or etanercept
  • Consent signed
  • Patient with social right
  • Patient who have been examined

Exclusion Criteria:

  • Pregnancy and breast feeding

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: QFTB-G and T-SPOT.TB tests
QFTB-G and T-SPOT.TB test before TST
Other Names:
  • There are no arms currently listed for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Therapeutic impact
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
medico-economic impact
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Xavier Mariette, Pr, Assistance Publique - Hôpitaux de Paris

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

December 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P070310
  • 2008-A00744-51 (Other Identifier: IDRCB)

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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