Ulcerative ColitisVESTNCT03257345
VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease
An observational study of Ulcerative Colitis and Crohn's Disease, run by University Hospital Southampton NHS Foundation Trust at 22 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- How many people
- 360 participants
- Where
- 22 sitesUnited Kingdom
- Study dates
- 3 Feb 2017to 31 Dec 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inflammatory bowel disease due to start vedolizumab for the first time as part of routine therapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United Kingdom22 sites, 22 recruiting
- Recruiting
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2EP
Kapil Kapur, MBBS
- Recruiting
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, BN2 5BE
Melissa Smith, MbChB
- Recruiting
West Suffolk NHS Foundation Trust
Bury St Edmunds, Suffolk, IP33 2QZ
Daniel Sharpstone, MB BS
- Recruiting
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW
Tariq Ahmad, MBChB
- Recruiting
United Lincolnshire Hospitals NHS Trust
Grantham, Lincolnshire, NG31 8DG
Tariq Mahmood, MBBS
- Recruiting
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, West Yorkshire, HD3 3EA
Sunil Sonwalkar, MBBS
- Recruiting
Kingston Hospital NHS Foundation Trust
Kingston, Greater London, KT2 7QB
Fiona Donovan, MSc
- Recruiting
Aintree University Hospital NHS Foundation Trust
Liverpool, Merseyside, L9 7AL
Keith Bodger, MBChB
- Recruiting
Barts Health NHS Trust
London, Greater London, E1 1BB
Klaartje Kok, MBBS
- Recruiting
London North West Healthcare NHS Trust
London, Greater London, HA1 3UJ
Ailsa Hart, BMBCh
- Recruiting
University College London Hospitals NHS Foundation Trust
London, Greater London, NW1 2BU
Stuart Bloom, MBBS
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 9RT
Peter Irving, MBBS
- Recruiting
King's College Hospital NHS Foundation Trust
London, Greater London, SE5 9RS
Alexandra Kent, MBChB
- Recruiting
Maidstone and Tunbridge Wells NHS Foundation Trust
Maidstone, Kent, ME16 9QQ
Bijay Baburajan, MBBS
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
John C Mansfield, MBBS
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
Alan Lobo, MBBS
- Recruiting
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire, SY3 8XQ
Jeffrey Butterworth, MBChB
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
Cheryl S Booker, BA, 023 8120 3713, cheryl.booker@uhs.nhs.uk
Fraser Cummings, MBChB
- Recruiting
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, TR1 3LJ
Anna Old, BSc
- Recruiting
West Hertfordshire Hospitals NHS Trust
Watford, Hertfordshire, WD18 0HB
Jonathan Landy, MBChB
- Recruiting
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP
Matthew Brookes, MBChB
- Recruiting
York Teaching Hospital NHS Foundation Trust
York, North Yorkshire, YO31 8HE
Martin Veysey, MBBS
About this study
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.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Real world outcomes
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid-free remission
Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2
Measured: Week 56
Secondary outcomes (6)
Remission and response
Remission and response rates at week 6, 14, 30 and 54
Measured: Multiple
Durable remission
Durable remission / response i.e. at week 14, 30 and 54
Measured: Multiple
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
Measured: TBC
HES data
Healthcare usage at 1 year using HES data
Measured: 1 year
Tolerance and safety
Tolerance and safety of vedolizumab at 1 year
Measured: 1 year
Description of disease
Description of the demographics, disease phenotype, disease and treatment history and concomitant medication use of patients receiving vedolizumab
Measured: TBC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start3 Feb 2017
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Fraser Cummings, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257345
- Sponsor's protocol ID
- RHM MED1307
- Acronym
- VEST
- Status last verified
- Sep 2018
- First submitted
- 17 Aug 2017
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03257345
- Acronym / sponsor ID
- VEST / RHM MED1307
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Real world outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory bowel disease due to start vedolizumab for the first time as part of routine therapy.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Remission and response
Time frame: Multiple
Durable remission
Time frame: Multiple
Effect of vedolizumab
Time frame: TBC
HES data
Time frame: 1 year
Tolerance and safety
Time frame: 1 year
Description of disease
Time frame: TBC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn's Disease, run by University Hospital Southampton NHS Foundation Trust at 22 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fraser Cummings, MBChB (023 8120 8462, fraser.cummings@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid-free remission (time frame: Week 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.