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Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis — FAVOUR  

Ulcerative Colitis Clinical Trial

Official title:
Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis

Clinical Trial Summary

The purpose of this study is to study the loss of vedolizumab in stool in patients with active ulcerative colitis (UC).

Patients with moderate-to-severe UC who are commencing induction therapy with vedolizumab will be enrolled into a prospective study and stool will be collected for faecal vedolizumab measurement at days 1, 4 and 7; and again at weeks 2, 6 and 14. They will also be evaluated at three time-points (weeks 2, 6 and 14) for clinical and biochemical UC disease activity as well as serum vedolizumab concentrations and anti-vedolizumab antibodies.

Clinical Trial Description

Primary objective

- To determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active UC.

Secondary objective (s)

- To evaluate whether the presence and quantity of vedolizumab in stool can be used to predict primary non-response to vedolizumab.

- To explore whether a correlation exists between stool vedolizumab concentrations, serum vedolizumab concentrations and UC disease activity and extent.

- To determine whether there is a correlation between stool and serum vedolizumab levels and trafficking of Th1/Th17 effector memory CD4+ T-cells (the key pathogenic subset in IBD) to the colon in UC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04006080
Study type Interventional
Source Guy's and St Thomas' NHS Foundation Trust
Contact
Status Recruiting
Phase Phase 4
Start date July 1, 2019
Completion date March 2020
View Details
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