Clinical trial NCT03257345: VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease
Official title: VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: Real world outcomes
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: Liverpool University Hospitals NHS Foundation Trust
First posted: 2017-08-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with inflammatory bowel disease due to start vedolizumab for the first time as part of routine therapy.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Steroid-free remission
timeFrame: Week 56
Secondary outcomes:
measure: Remission and response
timeFrame: Multiple
measure: Durable remission
timeFrame: Multiple
measure: Effect of vedolizumab
timeFrame: TBC
measure: HES data
timeFrame: 1 year
measure: Tolerance and safety
timeFrame: 1 year
measure: Description of disease
timeFrame: TBC
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
state: Cornwall
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
state: Devon
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
state: East Sussex
city: Kingston
country: United Kingdom
facility: Kingston Hospital NHS Foundation Trust
state: Greater London
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: Greater London
city: London
country: United Kingdom
facility: London North West Healthcare NHS Trust
state: Greater London
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
state: Greater London
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
state: Greater London
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: Greater London
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Watford
country: United Kingdom
facility: West Hertfordshire Hospitals NHS Trust
state: Hertfordshire
city: Maidstone
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Foundation Trust
state: Kent
city: Grantham
country: United Kingdom
facility: United Lincolnshire Hospitals NHS Trust
state: Lincolnshire
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital NHS Foundation Trust
state: Merseyside
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
state: North Yorkshire
city: Shrewsbury
country: United Kingdom
facility: Shrewsbury and Telford Hospital NHS Trust
state: Shropshire
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
city: Bury Saint Edmunds
country: United Kingdom
facility: West Suffolk NHS Foundation Trust
state: Suffolk
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
state: Tyne And Wear
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
state: West Midlands
city: Huddersfield
country: United Kingdom
facility: Calderdale and Huddersfield NHS Foundation Trust
state: West Yorkshire
Study officials:
References: