NCT02878083

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• ULCERATIVE COLITIS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-11
• Primary completion: 2020-01-01
• Completion: 2021-01-01
• First posted: 2016-08-25
• Last updated: 2023-02-17

Locations

4 sites across 1 country: France