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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00811343

Acronym

ETAT

Enrollment

430

Registered

2008-12-19

Start date

2008-12-31

Completion date

2012-06-30

Last updated

2014-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

anti TNF Therapy, Tuberculosis, Tuberculin test, QFTB-G, T-SPOT.TB, Need anti TNF Therapy

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

Interventions

BIOLOGICALQFTB-G and T-SPOT.TB tests

QFTB-G and T-SPOT.TB test before TST

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Therapeutic impact	12 months

Secondary

Measure	Time frame
medico-economic impact	12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026