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CompletedNCT00811343ETATUpdated Jan 7, 2014

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

An interventional study of QFTB-G and T-SPOT.TB tests in Tuberculosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-07.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
430
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Tuberculosis

Keywords

  • anti TNF Therapy
  • Tuberculosis
  • Tuberculin test
  • QFTB-G
  • T-SPOT.TB
  • Need anti TNF Therapy
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 430 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnancy and breast feeding
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
430 participants (actual)

Study arms

  • Experimental
    1

    Biological: QFTB-G and T-SPOT.TB tests

Interventions

  • BiologicalQFTB-G and T-SPOT.TB tests

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

    Also known as: There are no arms currently listed for this study.

06

What researchers measure

Primary outcomes

  1. Therapeutic impact

    Time frame: 12 months

Secondary outcomes

  1. medico-economic impact

    Time frame: 12 months

07

Study locations

1 site
  • Bicêtre hospital
    Le Kremlin Bicêtre, 94275, France
08

References and documents

Publications

  • 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. PubMed 29478790 ↗
  • 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. PubMed 22258485 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00811343
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Dec 19, 2008
Start date
Dec 2008
Primary completion
Dec 2010
Completion
Jun 2012
Last update
Jan 7, 2014

Study contacts

Xavier Mariette, Pr
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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