Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease

PHASE4TerminatedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

July 1, 2016

Primary Completion Date

January 11, 2022

Study Completion Date

January 23, 2023

Conditions
Crohn Disease
Interventions
DRUG

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."

Trial Locations (5)

42055

Chu Saint Etienne, Saint-Etienne

69230

CHU Lyon-Sud, Hospices Civils de Lyon, PIERRE-BENITE, Pierre-Bénite

80000

CHU d'Amiens, Amiens

94270

CHU Kremlin Bicetre, Paris

06200

CHU L'Archet, Nice

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Theradiag

OTHER

collaborator

Takeda

INDUSTRY

lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER