TuberculosisETATNCT00811343
Impact of New Immunological Diagnosis Tests of Latent Tuberculosis Before Anti TNF Therapy
A study testing QFTB-G and T-SPOT.TB tests in people with Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- QFTB-G and T-SPOT.TB tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Tuberculosis
- Being tested
- QFTB-G and T-SPOT.TB tests
- Keywords
- anti TNF Therapy, Tuberculosis, Tuberculin test, QFTB-G, T-SPOT.TB, Need anti TNF Therapy
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFTB-G and T-SPOT.TB testsBiological
Also called There are no arms currently listed for this study.
QFTB-G and T-SPOT.TB test before TST
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: QFTB-G and T-SPOT.TB tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic impact
Measured: 12 months
Secondary outcomes (1)
medico-economic impact
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Mariette, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811343
- Sponsor's protocol ID
- P070310
- Other IDs
- 2008-A00744-51
- Acronym
- ETAT
- Status last verified
- Jan 2014
- First submitted
- 18 Dec 2008
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
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 29478790Mariette 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.
- ClinicalTrials.gov ID
- NCT00811343
- Acronym / sponsor ID
- ETAT / P070310
- Conditions
- Tuberculosis
- Keywords
- anti TNF Therapy, Tuberculosis, Tuberculin test, QFTB-G, T-SPOT.TB, Need anti TNF Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: QFTB-G and T-SPOT.TB tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnancy and breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QFTB-G and T-SPOT.TB testsAlso: There are no arms currently listed for this study.QFTB-G and T-SPOT.TB test before TST | Biological | 1 |
Primary outcome
Therapeutic impact
Time frame: 12 months
1 secondary outcome
medico-economic impact
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
- Derived from this study: PubMed 29478790Freund 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.
- Derived from this study: PubMed 22258485Mariette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Mariette, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QFTB-G and T-SPOT.TB tests in people with Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic impact (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00811343, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.