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NCT03257345 Clinical Trial

VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

— VEST  

Official title:
VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03257345
Other study ID # RHM MED1307
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 3, 2017
Est. completion date December 31, 2019

Study information
Verified date September 2018
Source University Hospital Southampton NHS Foundation Trust
Contact Fraser Cummings, MBChB
Phone 023 8120 8462
Email fraser.cummings@uhs.nhs.uk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 360
Est. completion date December 31, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Barnsley Hospital NHS Foundation Trust Barnsley South Yorkshire
United Kingdom Brighton and Sussex University Hospitals NHS Trust Brighton East Sussex
United Kingdom West Suffolk NHS Foundation Trust Bury Saint Edmunds Suffolk
United Kingdom Royal Devon and Exeter NHS Foundation Trust Exeter Devon
United Kingdom United Lincolnshire Hospitals NHS Trust Grantham Lincolnshire
United Kingdom Calderdale and Huddersfield NHS Foundation Trust Huddersfield West Yorkshire
United Kingdom Kingston Hospital NHS Foundation Trust Kingston Greater London
United Kingdom Aintree University Hospital NHS Foundation Trust Liverpool Merseyside
United Kingdom Barts Health NHS Trust London Greater London
United Kingdom Guy's and St Thomas' NHS Foundation Trust London Greater London
United Kingdom King's College Hospital NHS Foundation Trust London Greater London
United Kingdom London North West Healthcare NHS Trust London Greater London
United Kingdom University College London Hospitals NHS Foundation Trust London Greater London
United Kingdom Maidstone and Tunbridge Wells NHS Foundation Trust Maidstone Kent
United Kingdom The Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle Upon Tyne Tyne And Wear
United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust Sheffield South Yorkshire
United Kingdom Shrewsbury and Telford Hospital NHS Trust Shrewsbury Shropshire
United Kingdom University Hospital Southampton NHS Foundation Trust Southampton Hampshire
United Kingdom Royal Cornwall Hospitals NHS Trust Truro Cornwall
United Kingdom West Hertfordshire Hospitals NHS Trust Watford Hertfordshire
United Kingdom The Royal Wolverhampton NHS Trust Wolverhampton West Midlands
United Kingdom York Teaching Hospital NHS Foundation Trust York North Yorkshire

Sponsors (3)
Lead Sponsor Collaborator
University Hospital Southampton NHS Foundation Trust Aintree University Hospitals NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Remission and response Remission and response rates at week 6, 14, 30 and 54 Multiple
Secondary Durable remission Durable remission / response i.e. at week 14, 30 and 54 Multiple
Secondary Effect of vedolizumab Effect of vedolizumab on disease activity as measured by the PRO2, IBD Control PROM, Physician's Global Assessment and biomarkers of disease activity TBC
Secondary HES data Healthcare usage at 1 year using HES data 1 year
Secondary Tolerance and safety Tolerance and safety of vedolizumab at 1 year 1 year
Secondary Description of disease Description of the demographics, disease phenotype, disease and treatment history and concomitant medication use of patients receiving vedolizumab TBC
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