Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.

Recruiting Phase 4 Interventional Study
Crohn's Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Other
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About This Trial
A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among d…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Major patient and having given consent to participate in the study * Patients with Crohn's disease who have responded primary to Adalimumab princeps or similar bio with loss of response to Adalimumab (40 mg every two weeks). * Patient affiliated to or entitled under a social s…
Contacts

Mathilde BARRAU, MD

(0)477829626

mathilde.barrau@chu-st-etienne.fr

CONTACT

Sandra COURNIER, project manager

(0)477127652

sandra.cournier@chu-st-etienne.fr

CONTACT