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

University Hospital Southampton NHS Foundation Trust360 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

360

Conditions

Ulcerative Colitis Crohn's Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Outcomes

Primary Outcomes

Steroid-free remission

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

Time frame: Week 56

Secondary Outcomes

Remission and response

Remission and response rates at week 6, 14, 30 and 54

Time frame: Multiple

Durable remission

Durable remission / response i.e. at week 14, 30 and 54

Time frame: 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

Time frame: TBC

HES data

Healthcare usage at 1 year using HES data

Time frame: 1 year

Tolerance and safety

Tolerance and safety of vedolizumab at 1 year

Time frame: 1 year

Description of disease

Description of the demographics, disease phenotype, disease and treatment history and concomitant medication use of patients receiving vedolizumab

Time frame: TBC

Central Contacts

Fraser Cummings, MBChB

CONTACT

023 8120 8462 fraser.cummings@uhs.nhs.uk

Cheryl S Booker, BA

CONTACT

023 8120 3713 cheryl.booker@uhs.nhs.uk

Data from ClinicalTrials.gov

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Exeter, Devon, United Kingdom

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Brighton, East Sussex, United Kingdom

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Kingston Hospital NHS Foundation Trust

Kingston, Greater London, United Kingdom

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