VEST: The UK Vedolizumab Real Life Experience Study in In... | NCT03257345

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2017Actual

Primary Completion Date

Sep 30, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Aug 17, 2017

First Submission Date that Met QC Criteria

Aug 17, 2017

First Posted Date

Aug 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2018

Last Update Posted Date

Sep 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fraser Cummings, Consultant Gastroenterologist, University Hospital Southampton NHS Foundation TrustPrincipal Investigator

Lead Sponsor

University Hospital Southampton NHS Foundation TrustOTHER

Collaborators

Name	Class
Guy's and St Thomas' NHS Foundation Trust	OTHER
Liverpool University Hospitals NHS Foundation Trust	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Remission and response	Remission and response rates at week 6, 14, 30 and 54	Multiple
Durable remission	Durable remission / response i.e. at week 14, 30 and 54

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with inflammatory bowel disease due to start vedolizumab for the first time as part of routine therapy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Cornwall Hospitals NHS Trust	Recruiting	Truro	Cornwall	TR1 3LJ	United Kingdom

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D003093	Colitis, Ulcerative
D003424	Crohn Disease

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases