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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Southampton NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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