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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-11

Study Completion Date

2021-01-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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ULCERATIVE COLITIS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VEDOLIZUMAB

300 mg IV

Group Type EXPERIMENTAL

VEDOLIZUMAB

Intervention Type DRUG

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

ADALIMUMAB

Intervention Type DRUG

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

Interventions

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VEDOLIZUMAB

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

Intervention Type DRUG

ADALIMUMAB

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

Intervention Type DRUG

Other Intervention Names

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entyvio HUMIRA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No