Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease (VEDO-PREDIRESP)

  • STATUS
    Recruiting
  • End date
    Jun 26, 2023
  • participants needed
    93
  • sponsor
    Centre Hospitalier Universitaire de Saint Etienne
Updated on 26 January 2022
antibiotic therapy
antibiotics
corticosteroids
remission
methotrexate
monoclonal antibodies
immunosuppressive agents
tumor necrosis factor
mercaptopurine
vedolizumab
crohn's disease
azathioprine
tumor necrosis factor alpha
tumour necrosis
colitis
mesalamine
faecal calprotectin

Summary

Vedolizumab (VDZ) is a monoclonal antibody which has shown its efficacy in Crohn's disease by inducing and maintaining clinical response/remission. The French marketing authorization was obtained for Crohn's disease in patients in failure with anti-TNF (Tumor Necrosis Factor) agents.

For Crohn's disease patients treated with vedolizumab, a strong association between vedolizumab serum levels and clinical response to induction and maintenance was demonstrated by anterior studies.

It could be of paramount interest to early identify Crohn's Disease patients under vedolizumab who will be responders to vedolizumab induction and to identify those who will achieve clinical remission under maintenance therapy with vedolizumab.

Researchers decided to assess the clinical response to vedolizumab induction at week 10. For clinically non-responders at week 10, an additional dose of 300 mg of vedolizumab will be infused at week 10 and then every four weeks.

Description

Vedolizumab (VDZ) is a monoclonal antibody that binds to the heterodimer alpha 4 beta 7 integrin and which has shown its efficacy in Crohn's disease by inducing and maintaining clinical response/remission. The French marketing authorization was obtained for Crohn's disease in patients in failure with anti-TNF (Tumor Necrosis Factor) agents.

For Crohn's disease patients treated with vedolizumab, a strong association between vedolizumab serum levels and clinical response to induction and maintenance was demonstrated by anterior studies.

It could be of paramount interest to early identify Crohn's Disease patients under vedolizumab who will be responders to vedolizumab induction and to identify those who will achieve clinical remission under maintenance therapy with vedolizumab.

Researchers decided to assess the clinical response to vedolizumab induction at week 10, as the Gemini III trial has reported, among patients who had experienced previous TNF (Tumor Necrosis Factor) antagonist failure. 15% of those given vedolizumab were in remission at week 6 (P=0.433) versus 12% under placebo. At week 10, 26% under vedolizumab were in remission versus 12% in the placebo arm.

Moreover, at week 10, the proportion of patients presenting a clinical response was significantly higher in Crohn's Disease patients treated with vedolizumab (46% vs 24%).

In this study, for clinically non-responders at week 10, an additional dose of 300 mg of vedolizumab will be infused at week 10 and then every four weeks. In a post hoc analysis of GEMINI 2, additional dose of vedolizumab in patients clinically non responders to vedolizumab obtained a clinical remission in 33% of case.

Details
Condition Crohn Disease
Treatment Vedolizumab
Clinical Study IdentifierNCT02768532
SponsorCentre Hospitalier Universitaire de Saint Etienne
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged over 18 years
Men or non-pregnant women
Patients with a diagnosis of Crohn's disease who requires to start Vedolizumab
Crohn's disease defined as a Crohn's disease Activity Index (CDAI) > 150 points and/or fecal calprotectin levels > 250 g/g of stool
Crohn's Disease patients with previous failure with TNF (Tumor Necrosis Factor) antagonist agents and unacceptable side-effects from steroids, and/or immunosuppressive agents (i.e., azathioprine, 6-mercaptopurine, or methotrexate). In France, Vedolizumab has to be prescribed only in patients in failure or intolerant to anti-TNF
Patient taking corticosteroids orally, concomitant immunosuppressive agents, mesalamine, and antibiotics are allowed at stable dose for at least three months before inclusion. Steroid tapering has to be set up at Week 10 after starting Vedolizumab, according to the European Crohn and Colitis Organisation (ECCO) recommendations with a progressive decrease of steroids of 5 mg/day every week until complete withdrawn
Informed written consent given

Exclusion Criteria

Existing pregnancy, lactation, or intended pregnancy within the next 15 months
Minors or History of disease, including mental/emotional disorder that might interfere with their participation in the study
Serious secondary illnesses of an acute or chronic nature, which in the opinion of the investigator renders the patient unsuitable for inclusion into the study
Inability to comply with the protocol requirements
Inability to fill in the diary cards during the last 7 days before each visit
Presence of an ileo-/colonic stoma
Patients with known colonic stricture and exclusive or predominant anal or perineal Crohn's disease lesions
Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years)
Short bowel syndrome
Previous treatments with natalizumab, efalizumab or rituximab
Prior extensive colonic resection, obstructive (symptomatic) intestinal stricture, abdominal abscess, active or latent tuberculosis
Documented Clostridium difficile superinfection
Indeterminate colitis
Concomitant leukocyte apheresis
Any contraindication to vedolizumab therapy
Patients who denied the protocol, not ability to accept or sign consent of the protocol
Subject involved in another interventional clinical trial
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