We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00811343
First Posted: December 19, 2008
Last Update Posted: January 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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


Condition Intervention
Tuberculosis Biological: QFTB-G and T-SPOT.TB tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Therapeutic impact [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • medico-economic impact [ Time Frame: 12 months ]

Enrollment: 430
Study Start Date: December 2008
Study Completion Date: June 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: QFTB-G and T-SPOT.TB tests
QFTB-G and T-SPOT.TB test before TST
Other Name: There are no arms currently listed for this study.

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811343


Locations
France
Bicêtre hospital
Le Kremlin Bicêtre, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Xavier Mariette, Pr Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00811343     History of Changes
Other Study ID Numbers: P070310
2008-A00744-51 ( Other Identifier: IDRCB )
First Submitted: December 18, 2008
First Posted: December 19, 2008
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
anti TNF Therapy
Tuberculosis
Tuberculin test
QFTB-G
T-SPOT.TB
Need anti TNF Therapy

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections