NCT04959851

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 185 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Diseases
• Colitis, Ulcerative
• Crohns Disease

Timeline

• Start date: 2021-12-02
• Primary completion: 2024-06-18
• Completion: 2024-06-18
• First posted: 2021-07-13
• Last updated: 2024-08-06

Locations

10 sites across 1 country: Belgium