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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03257345

Acronym

VEST

Enrollment

360

Registered

2017-08-22

Start date

2017-02-03

Completion date

2019-12-31

Last updated

2018-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

Real world outcomes

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Remission and response	Multiple	Remission and response rates at week 6, 14, 30 and 54
Tolerance and safety	1 year	Tolerance and safety of vedolizumab at 1 year
Description of disease	TBC	Description of the demographics, disease phenotype, disease and treatment history and concomitant medication use of patients receiving vedolizumab
HES data	1 year	Healthcare usage at 1 year using HES data

Countries

United Kingdom

Contacts

Primary ContactFraser Cummings, MBChB

fraser.cummings@uhs.nhs.uk023 8120 8462

Backup ContactCheryl S Booker, BA

cheryl.booker@uhs.nhs.uk023 8120 3713

Outcome results