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

NCT02878083 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-02-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

VEDOLIZUMAB

Infusion at week 0 week 2 week 6 week 14 for all patients Infusion at week 22 for responder patient only

DRUG

ADALIMUMAB

For nonresponder patients only : Injection at week 22 week 24 week 26 and week 28

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Mauna Kea Technologies

    collaborator INDUSTRY

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • ARNAUD BOURREILLE, MD-PHD · Nantes University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-11
Primary Completion
2020-01-31
Completion
2021-01-01

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02878083 on ClinicalTrials.gov