Impact of New Immunological Diagnosis Tests of Latent Tuberculosis Before Anti TNF Therapy (ETAT)
|ClinicalTrials.gov Identifier: NCT00811343|
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : January 7, 2014
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||Phase|
|Tuberculosis||Biological: QFTB-G and T-SPOT.TB tests||Not Applicable|
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
- 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 (Clinical Trial)|
|Actual Enrollment :||430 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||June 2012|
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.
- Therapeutic impact [ Time Frame: 12 months ]
- medico-economic impact [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811343
|Le Kremlin Bicêtre, France, 94275|
|Principal Investigator:||Xavier Mariette, Pr||Assistance Publique - Hôpitaux de Paris|