VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease
VEST
1 other identifier
observational
360
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2017
CompletedFirst Submitted
Initial submission to the registry
August 17, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 21, 2018
September 1, 2018
2.7 years
August 17, 2017
September 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Steroid-free remission
Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2
Week 56
Secondary Outcomes (6)
Remission and response
Multiple
Durable remission
Multiple
Effect of vedolizumab
TBC
HES data
1 year
Tolerance and safety
1 year
- +1 more secondary outcomes
Eligibility Criteria
Patients with inflammatory bowel disease due to start vedolizumab for the first time as part of routine therapy.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, TR1 3LJ, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, BN2 5BE, United Kingdom
Kingston Hospital NHS Foundation Trust
Kingston, Greater London, KT2 7QB, United Kingdom
Barts Health NHS Trust
London, Greater London, E1 1BB, United Kingdom
London North West Healthcare NHS Trust
London, Greater London, HA1 3UJ, United Kingdom
University College London Hospitals NHS Foundation Trust
London, Greater London, NW1 2BU, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 9RT, United Kingdom
King's College Hospital NHS Foundation Trust
London, Greater London, SE5 9RS, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
West Hertfordshire Hospitals NHS Trust
Watford, Hertfordshire, WD18 0HB, United Kingdom
Maidstone and Tunbridge Wells NHS Foundation Trust
Maidstone, Kent, ME16 9QQ, United Kingdom
United Lincolnshire Hospitals NHS Trust
Grantham, Lincolnshire, NG31 8DG, United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, Merseyside, L9 7AL, United Kingdom
York Teaching Hospital NHS Foundation Trust
York, North Yorkshire, YO31 8HE, United Kingdom
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire, SY3 8XQ, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2EP, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF, United Kingdom
West Suffolk NHS Foundation Trust
Bury St Edmunds, Suffolk, IP33 2QZ, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, West Yorkshire, HD3 3EA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Gastroenterologist
Study Record Dates
First Submitted
August 17, 2017
First Posted
August 22, 2017
Study Start
February 3, 2017
Primary Completion
September 30, 2019
Study Completion
December 31, 2019
Last Updated
September 21, 2018
Record last verified: 2018-09