Trial | NCT02878083  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    19
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.
Patients will be recruited before initiation of vedolizumab injections. The schedule for vedolizumab infusions will corresponding to the protocol follow-up visits (Week 0, W2, W6, W14, W22), and flexible sigmoidoscopy appointments will be performed at Week 0 and 22.

For responder patients, the end of the study will occured two weeks after the last vedolizumab infusion (W24).

At week 22, nonresponder patients to vedolizumab may be treated by adalimumab in the absence of contraindication and depending on the decision of the physician responsible for the patient. Patients will be treated every two weeks during 8 weeks. The protocol follow up will end 2 weeks after the fourth adalimumab injection.

During W0 and W22, colon biopsies will be collected. Blood samples will be collected on W0, W2, W6, W14, W22 (and W30 for non responder).
Study Started
Jan 11
2017
Primary Completion
Jan 31
2020
Study Completion
Jan 01
2021
Last Update
Feb 17
2023

Drug VEDOLIZUMAB

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

  • Other names: entyvio

Drug ADALIMUMAB

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

  • Other names: HUMIRA

VEDOLIZUMAB Experimental

300 mg IV

Criteria 

Inclusion Criteria:

Patients with moderate to severe UC defined by an overall Mayo score ≥ 5 and an endoscopic sub-score ≥ 2 points and rectal bleeding score ≥ 1 point
Extension > 15 cm from the anal margin
Requiring treatment with biotherapy and meeting the indications for the treatment
Affiliated with a social security scheme

Exclusion Criteria:

Crohn's disease or unclassified colitis
Severe acute colitis
Requirement for immediate surgical treatment
Previous treatment with vedolizumab or anti-TNF-α
Contraindication to the use of vedolizumab or an anti-TNF-α agent
Contraindication to the use of adalimumab
Corticosteroid therapy > 20 mg/day
Corticosteroid therapy started within the previous two weeks
Conventional Immunosppressor started within the previous month
Colonic dysplasia or known cancer
Likelihood to refuse two rectosigmoidoscopies, performed eighteen weeks apart
Pregnant or lactating women
No Results Posted