VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease
- Conditions
- Crohn's DiseaseUlcerative Colitis
- Registration Number
- NCT03257345
- Brief Summary
Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's disease. The aim of this study is to capture the early real life UK experience of vedolizumab including the outcomes of treatment, describing the patient population treated, drug persistence, IBD control PROM, durable remission, tolerance and safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 360
- Participants being given vedolizumab as part of routine care, and vedo naïve prior to study
- Age 18 or over
- Written informed consent obtained from patient for participation in the UK IBD Registry
- Patient unwilling to take part in the UK IBD Registry
- Unable to obtain written informed consent
- Patient is, in the opinion of the investigator, not suitable to participate in the study
- Patients with contraindications to the use of vedolizumab
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Steroid-free remission Week 56 Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2
- Secondary Outcome Measures
Name Time Method HES data 1 year Healthcare usage at 1 year using HES data
Remission and response Multiple Remission and response rates at week 6, 14, 30 and 54
Durable remission Multiple Durable remission / response i.e. at week 14, 30 and 54
Effect of vedolizumab TBC Effect of vedolizumab on disease activity as measured by the PRO2, IBD Control PROM, Physician's Global Assessment and biomarkers of disease activity
Description of disease TBC Description of the demographics, disease phenotype, disease and treatment history and concomitant medication use of patients receiving vedolizumab
Tolerance and safety 1 year Tolerance and safety of vedolizumab at 1 year
Trial Locations
- Locations (22)
Kingston Hospital NHS Foundation Trust
🇬🇧Kingston, Greater London, United Kingdom
London North West Healthcare NHS Trust
🇬🇧London, Greater London, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, Greater London, United Kingdom
Aintree University Hospital NHS Foundation Trust
🇬🇧Liverpool, Merseyside, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, South Yorkshire, United Kingdom
Barnsley Hospital NHS Foundation Trust
🇬🇧Barnsley, South Yorkshire, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
🇬🇧Huddersfield, West Yorkshire, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, East Sussex, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, Hampshire, United Kingdom
United Lincolnshire Hospitals NHS Trust
🇬🇧Grantham, Lincolnshire, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
🇬🇧Exeter, Devon, United Kingdom
West Hertfordshire Hospitals NHS Trust
🇬🇧Watford, Hertfordshire, United Kingdom
Shrewsbury and Telford Hospital NHS Trust
🇬🇧Shrewsbury, Shropshire, United Kingdom
Maidstone and Tunbridge Wells NHS Foundation Trust
🇬🇧Maidstone, Kent, United Kingdom
York Teaching Hospital NHS Foundation Trust
🇬🇧York, North Yorkshire, United Kingdom
West Suffolk NHS Foundation Trust
🇬🇧Bury Saint Edmunds, Suffolk, United Kingdom
Barts Health NHS Trust
🇬🇧London, Greater London, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, Greater London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
The Royal Wolverhampton NHS Trust
🇬🇧Wolverhampton, West Midlands, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, Greater London, United Kingdom
Royal Cornwall Hospitals NHS Trust
🇬🇧Truro, Cornwall, United Kingdom