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

• Conditions: Crohn's Disease; Ulcerative Colitis

• Registration Number: NCT03257345
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-03
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-21
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Steroid-free remission	Week 56	Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2

Secondary Outcome Measures

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

Trial Locations

Locations (22)

Royal Cornwall Hospitals NHS Trust; 🇬🇧 Truro, Cornwall, United Kingdom

Royal Devon and Exeter NHS Foundation Trust; 🇬🇧 Exeter, Devon, United Kingdom

Brighton and Sussex University Hospitals NHS Trust; 🇬🇧 Brighton, East Sussex, United Kingdom

Kingston Hospital NHS Foundation Trust; 🇬🇧 Kingston, Greater London, United Kingdom

Barts Health NHS 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

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

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, Hampshire, United Kingdom

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