Value of Pharmacokinetic Assays in the Prediction of Therapeutic Response in Ulcerative Colitis

NATerminatedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

March 4, 2019

Primary Completion Date

April 15, 2022

Study Completion Date

June 28, 2022

Conditions
Ulcerative Colitis
Interventions
PROCEDURE

Blood sample

Blood samples will be systematically collected at W0, W2, W6, W14 and W52 for vedolizumab pharmacokinetic parameters, including the vedolizumab trough levels and the specific anti-vedolizumab antibody. A supplementary blood sample will be collected at W10 which is the point where a significant greater number of patients were in remission.

DEVICE

Rectosigmoidoscopy

Rectosigmoidoscopy will be performed in each center at time points W0, W10 and W52.

Trial Locations (5)

42055

CHU Saint-Etienne, Saint-Etienne

69230

Ch Lyon Sud, Pierre-Bénite

80000

CHU Amiens, Amiens

94270

CHU Kremlin Bicêtre, Le Kremlin-Bicêtre

06200

Chu L'Archet, Nice

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

collaborator

Theradiag

OTHER

lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER