Impact of New Immunological Diagnosis Tests of Latent Tuberculosis Before Anti TNF Therapy (ETAT)
Primary Purpose
Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QFTB-G and T-SPOT.TB tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis focused on measuring anti TNF Therapy, Tuberculosis, Tuberculin test, QFTB-G, T-SPOT.TB, Need anti TNF Therapy
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
Sites / Locations
- Bicêtre hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Therapeutic impact
Secondary Outcome Measures
medico-economic impact
Full Information
NCT ID
NCT00811343
First Posted
December 18, 2008
Last Updated
January 6, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00811343
Brief Title
Impact of New Immunological Diagnosis Tests of Latent Tuberculosis Before Anti TNF Therapy
Acronym
ETAT
Official Title
Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
anti TNF Therapy, Tuberculosis, Tuberculin test, QFTB-G, T-SPOT.TB, Need anti TNF Therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
430 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
QFTB-G and T-SPOT.TB tests
Other Intervention Name(s)
There are no arms currently listed for this study.
Intervention Description
QFTB-G and T-SPOT.TB test before TST
Primary Outcome Measure Information:
Title
Therapeutic impact
Time Frame
12 months
Secondary Outcome Measure Information:
Title
medico-economic impact
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Mariette, Pr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bicêtre hospital
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29478790
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.
Results Reference
derived
PubMed Identifier
22258485
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.
Results Reference
derived
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Impact of New Immunological Diagnosis Tests of Latent Tuberculosis Before Anti TNF Therapy
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