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

Tuberculosis Clinical Trial

— ETAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811343
• Other study ID #: P070310
• Secondary ID: 2008-A00744-51
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: January 6, 2014
• Start date: December 2008
• Est. completion date: June 2012

Study information

• Verified date: January 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: June 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

Biological:
• QFTB-G and T-SPOT.TB tests
QFTB-G and T-SPOT.TB test before TST

Locations

Country	Name	City	State
France	Bicêtre hospital	Le Kremlin Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic impact		12 months	No
Secondary	medico-economic impact		12 months	No