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

September 20, 2018 updated by: Fraser Cummings, University Hospital Southampton NHS Foundation Trust
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Recruiting
        • Royal Cornwall Hospitals NHS trust
        • Contact:
          • Anna Old, BSc
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon and Exeter NHS Foundation Trust
        • Contact:
          • Tariq Ahmad, MBChB
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Recruiting
        • Brighton and Sussex University Hospitals NHS Trust
        • Contact:
          • Melissa Smith, MbChB
    • Greater London
      • Kingston, Greater London, United Kingdom, KT2 7QB
        • Recruiting
        • Kingston Hospital Nhs Foundation Trust
        • Contact:
          • Fiona Donovan, MSc
      • London, Greater London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
          • Alexandra Kent, MBChB
      • London, Greater London, United Kingdom, E1 1BB
        • Recruiting
        • Barts Health NHS Trust
        • Contact:
          • Klaartje Kok, MBBS
      • London, Greater London, United Kingdom, HA1 3UJ
        • Recruiting
        • London North West Healthcare NHS Trust
        • Contact:
          • Ailsa Hart, BMBCh
      • London, Greater London, United Kingdom, NW1 2BU
        • Recruiting
        • University College London Hospitals NHS Foundation Trust
        • Contact:
          • Stuart Bloom, MBBS
      • London, Greater London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Peter Irving, MBBS
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital Southampton NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Fraser Cummings, MBChB
    • Hertfordshire
      • Watford, Hertfordshire, United Kingdom, WD18 0HB
        • Recruiting
        • West Hertfordshire Hospitals Nhs Trust
        • Contact:
          • Jonathan Landy, MBChB
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Recruiting
        • Maidstone and Tunbridge Wells NHS Foundation Trust
        • Contact:
          • Bijay Baburajan, MBBS
    • Lincolnshire
      • Grantham, Lincolnshire, United Kingdom, NG31 8DG
        • Recruiting
        • United Lincolnshire Hospitals NHS Trust
        • Contact:
          • Tariq Mahmood, MBBS
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L9 7AL
        • Recruiting
        • Aintree University Hospital NHS Foundation Trust
        • Contact:
          • Keith Bodger, MBChB
    • North Yorkshire
      • York, North Yorkshire, United Kingdom, YO31 8HE
        • Recruiting
        • York Teaching Hospital NHS Foundation Trust
        • Contact:
          • Martin Veysey, MBBS
    • Shropshire
      • Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
        • Recruiting
        • Shrewsbury and Telford Hospital NHS Trust
        • Contact:
          • Jeffrey Butterworth, MBChB
    • South Yorkshire
      • Barnsley, South Yorkshire, United Kingdom, S75 2EP
        • Recruiting
        • Barnsley Hospital NHS Foundation Trust
        • Contact:
          • Kapil Kapur, MBBS
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
          • Alan Lobo, MBBS
    • Suffolk
      • Bury Saint Edmunds, Suffolk, United Kingdom, IP33 2QZ
        • Recruiting
        • West Suffolk NHS Foundation Trust
        • Contact:
          • Daniel Sharpstone, MB BS
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
        • Recruiting
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
        • Contact:
          • John C Mansfield, MBBS
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • Recruiting
        • The Royal Wolverhampton NHS Trust
        • Contact:
          • Matthew Brookes, MBChB
    • West Yorkshire
      • Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
        • Recruiting
        • Calderdale and Huddersfield NHS Foundation Trust
        • Contact:
          • Sunil Sonwalkar, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with inflammatory bowel disease due to start vedolizumab for the first time as part of routine therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steroid-free remission
Time Frame: Week 56
Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2
Week 56

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Collaborators

Guy's and St Thomas' NHS Foundation Trust
Liverpool University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2017

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHM MED1307

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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