Clinical trial NCT00811343: Impact of New Immunological Diagnosis Tests of Latent Tuberculosis Before Anti TNF Therapy
Official title: Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: anti TNF Therapy
Tuberculosis
Tuberculin test
QFTB-G
T-SPOT.TB
Need anti TNF Therapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility 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

Primary outcomes:
measure: Therapeutic impact
timeFrame: 12 months
Secondary outcomes:
measure: medico-economic impact
timeFrame: 12 months
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: Bicêtre hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Xavier Mariette, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freund R, Granger B, Francois C, Carcelain G, Ravaud P, Mariette X, Fautrel B. Cost-effectiveness analysis of strategies using new immunological diagnostic tests of latent tuberculosis infection before TNF-blockers therapy. Presse Med. 2018 Feb;47(2):e9-e13. doi: 10.1016/j.lpm.2017.09.029. Epub 2018 Feb 23.
citation: Mariette X, Baron G, Tubach F, Liote F, Combe B, Miceli-Richard C, Flipo RM, Goupille P, Allez M, Salmon D, Emilie D, Carcelain G, Ravaud P. Influence of replacing tuberculin skin test with ex vivo interferon gamma release assays on decision to administer prophylactic antituberculosis antibiotics before anti-TNF therapy. Ann Rheum Dis. 2012 Nov;71(11):1783-90. doi: 10.1136/annrheumdis-2011-200408. Epub 2012 Jan 17.