Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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.