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

NCT00811343 | Completed

• 2 other identifiers: P0703102008-A00744-51
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Therapeutic impact

  12 months

Secondary Outcomes (1)

• medico-economic impact

  12 months

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

QFTB-G and T-SPOT.TB tests BIOLOGICAL

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

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy and breast feeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bicêtre hospital

Le Kremlin-Bicêtre, 94275, France

Location

Related Publications (2)

• 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.

  PMID: 29478790 DERIVED

• 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.

  PMID: 22258485 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Xavier Mariette, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2012
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

FR (1)