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Clinical Trial Summary

The purpose of this study is to describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 months following treatment initiation with vedolizumab.


Clinical Trial Description

This is a non-interventional, single-cohort, prospective study of participants with moderate to severe CD. The study will review medical charts with prospective patient-reported outcome measures to provide real-world data to describe clinical outcomes and participant-reported symptom experience over 12 months following vedolizumab treatment initiation.

The study will enroll approximately 140 participants. All participants will be enrolled in one observational group:

• Vedolizumab

This multicenter trial will be conducted in Canada. The overall duration of study will be approximately 24 months, including participant's enrolment period of 12 months and follow-up data collection period of 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04349449
Study type Observational
Source Takeda
Contact
Status Withdrawn
Phase
Start date September 30, 2020
Completion date November 30, 2022

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