OCTAVO: The impact of vedolizumab on prescribing and quality of life
Research type
Research Study
Full title
A multi-centre observational study to describe the impact of vedolizumab on concomitant prescribing and quality of life in patients with ulcerative colitis and Crohn’s disease in the UK and Ireland: OCTAVO
IRAS ID
243291
Contact name
Gareth Parkes
Contact email
Sponsor organisation
Takeda UK Ltd.
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
This is a multi-centre, observational study to look into the prescribing of vedolizumab (VDZ) in patients with ulcerative colitis (UC) and Crohn’s disease (CD) in the UK and Ireland. The study aims to describe how VDZ affects the prescribing of other medicines such as corticosteroids, immunomodulators and antibiotics, compared with an alternative type of medicine (anti-TNF), and the quality of life of patients treated with VDZ.
There is currently little real world evidence related to the impact of VDZ on corticosteroid, immunomodulator and antibiotic prescribing, and quality of life. This study has been designed to contribute to the existing evidence.
This study will use data collected retrospectively from medical records to compare the prescribing of medicines such as corticosteroids, immunomodulators and antibiotics in patients who have received VDZ with those who have recieved an anti-TNF medicine (Cohort 1: 170 patients with UC (85 patients treated with VDZ and 85 patients treated with an anti-TNF). Quality of life in patients who take VDZ for UC or CD in routine clinical practice will be described, by prospective completion of 4 health-related quality of life (HRQoL) questionnaires at 4 time points over 12 months from initiation of VDZ. In addition, 1 questionnaire comprising of 13 questions about patient experience of treatment will be administered at baseline only (Cohort 2: 60 patients treated with VDZ (30 patients with UC and 30 patients with CD)).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0094
Date of REC Opinion
4 May 2018
REC opinion
Further Information Favourable Opinion