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

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Biological: QFTB-G and T-SPOT.TB tests

• Registration Number: NCT00811343
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-18
• Study First Posted: 2008-12-19
• Primary Completion: 2010-12
• Study Completion: 2012-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-06
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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

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Exclusion Criteria

• Pregnancy and breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	QFTB-G and T-SPOT.TB tests	-

Primary Outcome Measures

Name	Time	Method
Therapeutic impact	12 months

Secondary Outcome Measures

Name	Time	Method
medico-economic impact	12 months

Trial Locations

Locations (1)

Bicêtre hospital; 🇫🇷 Le Kremlin Bicêtre, France