A Study on How Vedolizumab is Given and the Outcomes for Adults With Inflammatory Bowel Disease (VARIETY-Belgium)

Completed

• Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohns Disease

• Registration Number: NCT04959851
• Lead Sponsor: Takeda

Brief Summary

IBD consists of either ulcerative colitis or Crohn's disease.

The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include how vedolizumab is given, which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).

Detailed Description

This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab according to the current SmPC in the real world setting.

The study will enroll approximately 200 participants. The data will be collected prospectively and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

• Participants with IBD

This multi-center study will be conducted in Belgium at specialized gastroenterology centers.

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-13
• Study Start: 2021-12-02
• Primary Completion: 2024-06-18
• Study Completion: 2024-06-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

1. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.

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Exclusion Criteria

1. Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
2. Current or planned participation in an interventional clinical trial for CD or UC.
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Change in Vedolizumab Dosing Frequency	Baseline up to 24 months
Number of Participants Who Changed to Another Treatment	Baseline up to 24 months
Number of Participants With Reason for Treatment Change	Baseline up to 24 months
Number of Participants Who Discontinued the Vedolizumab Treatment	Baseline up to 24 months
Percentage of Participants Persisting to Treatment With Vedolizumab IV Compared to Participants With Treatment Change Up to 12 Months	Baseline up to 12 months
Time to any Treatment Change	Baseline up to 24 months

Trial Locations

Locations (10)

Erasme; 🇧🇪 Bruxelles, Belgium

CHWAPI; 🇧🇪 Tournai, Belgium

UZA; 🇧🇪 Antwerpen, Belgium

ZOL; 🇧🇪 Genk, Belgium

GZA St. Vincentius; 🇧🇪 Antwerpen, Belgium

AZ St. Lucas; 🇧🇪 Gent, Belgium

CHU Liège; 🇧🇪 Liège, Belgium

CHC MontLégia; 🇧🇪 Liège, Belgium

AZ Delta; 🇧🇪 Roeselaere, Belgium

CHR Citadelle; 🇧🇪 Liège, Belgium