Skip to main content
OpenTrials
Completed

NCT Number: NCT04959851

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohns Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GZA St. Vincentius, Antwerp, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Current or planned participation in an interventional clinical trial for CD or UC.
  • Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Persisting to Treatment With Vedolizumab IV Compared to Participants With Treatment Change Up to 12 Months

    Time frame: Baseline up to 12 months

  2. Time to any Treatment Change

    Time frame: Baseline up to 24 months

  3. Number of Participants With Reason for Treatment Change

    Time frame: Baseline up to 24 months

  4. Number of Participants With Change in Vedolizumab Dosing Frequency

    Time frame: Baseline up to 24 months

  5. Number of Participants Who Discontinued the Vedolizumab Treatment

    Time frame: Baseline up to 24 months

  6. Number of Participants Who Changed to Another Treatment

    Time frame: Baseline up to 24 months

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Prospective, Non-Interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.