Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

Sponsor
Nantes University Hospital
Study ID
NCT02878083
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VEDOLIZUMAB — DRUG
    Infusion at week 0 week 2 week 6 week 14 for all patients Infusion at week 22 for responder patient only
  • ADALIMUMAB — DRUG
    For nonresponder patients only : Injection at week 22 week 24 week 26 and week 28

Study Details

The main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to rhodamine. This project should allow the development of a biomarker of therapeutic efficacy for vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while respecting manufacturing standards and Good manufacturing procedures.

Key Dates

Start date
Jan 11, 2017
Status verified
Feb 2023
Primary completion
Jan 31, 2020
Completion
Jan 1, 2021

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VEDOLIZUMAB
    300 mg IV

Primary Outcome Measure

Demonstrate the feasibility of an ex vivo labeling of intestinal immune cells with a combination of two markers: vedolizumab-FITC and adalimumab-Alexa Fluor 647 [ Time Frame: week 0 ]

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