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

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ClinicalTrials.gov Identifier: NCT00811343
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Tuberculosis Biological: QFTB-G and T-SPOT.TB tests

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
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.
Study Start Date : December 2008
Primary Completion Date : December 2010
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes Tuberculosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: December 19, 2008    Key Record Dates
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