FAVOUR
Research type
Research Study
Full title
Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis
IRAS ID
210880
Contact name
Peter Irving
Contact email
Sponsor organisation
Guy's & St Thomas' NHS Foundation Trust
Eudract number
2018-002794-21
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
Vedolizumab is a newly available and highly effective treatment for patients with ulcerative colitis (UC). During the trials that demonstrated its benefit, an exposure-response relationship was noted. This meant that patients with higher blood concentrations of the drug were more likely to achieve a favourable outcome than those with lower concentrations.
It has previously been demonstrated that other similar drugs (monoclonal antibodies, infliximab and adalimumab) can be lost into the stool of patients with UC. This can potentially result in lower blood concentrations and therefore in reducing the effectiveness of the drug. However, the loss of vedolizumab into stool has not previously been studied. Therefore, we plan to evaluate the amount of drug present in the stool of patients with UC as well as assessing the effect of stool loss on blood concentrations and the effectiveness of the drug.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1531
Date of REC Opinion
11 Sep 2018
REC opinion
Favourable Opinion