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

RC15_0457

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.

2017-01-11

2020-01-01

2021-01-01

Terminated

19

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}

2023-02-17