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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00811343
First received: December 18, 2008
Last updated: January 6, 2014
Last verified: January 2014

December 18, 2008
January 6, 2014
December 2008
December 2010   (final data collection date for primary outcome measure)
Therapeutic impact [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00811343 on ClinicalTrials.gov Archive Site
medico-economic impact [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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 :

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

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Tuberculosis
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.
Experimental: 1
Intervention: Biological: QFTB-G and T-SPOT.TB tests
Mariette X, Baron G, Tubach F, Lioté 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 γ 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
June 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00811343
P070310, 2008-A00744-51
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Xavier Mariette, Pr Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP