NCT05192863

A Study of Vedolizumab in Adults With Crohn's Disease (CD)

Complete Remission in Patients With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab - A Multicenter, Prospective Observational Cohort Study in Canada, Italy, and Israel

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography. Participants will be treated with vedolizumab according to their clinic's standard practice.

Detailed description

This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating treatment with vedolizumab according to the current summary of product characteristics (SmPC) in the real world setting. The study will enroll approximately 100 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort: Participants with CD This multi-center study will be conducted in Canada, Italy, and Israel at specialized gastroenterology centers. The overall duration of the study will be 18 months.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2023-03-20
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2022-01-14
• Last updated: 2025-11-13

Locations

10 sites across 3 countries: Canada, Israel, Italy

Regulatory

• FDA-regulated drug study