47
Participants
Start Date
July 1, 2016
Primary Completion Date
January 11, 2022
Study Completion Date
January 23, 2023
Vedolizumab
"During each 8 visits (screening, V0, V1, V2, V3, V4, V5, V6) at weeks-1, 0, 2, 6, 10, 14, 22, 54, respectively), the following parameters will be systematically recorded: Crohn's disease Activity Index (CDAI), adverse events.~Blood and fecal samples will be systematically collected at weeks 0, 2, 6, 10, 14, 22 and 54 for routine serum ultrasensitive CRP (C-Reactive Protein) and fecal calprotectin assessments and for vedolizumab pharmacokinetic parameters, including the vedolizumab trough levels and the specific anti-Vedolizumab antibodies. In case of loss of response, an additional measurement of serum CRP (C-Reactive Protein), fecal calprotectin and Vedolizumab pharmacologic parameters will be performed."
Chu Saint Etienne, Saint-Etienne
CHU Lyon-Sud, Hospices Civils de Lyon, PIERRE-BENITE, Pierre-Bénite
CHU d'Amiens, Amiens
CHU Kremlin Bicetre, Paris
CHU L'Archet, Nice