Crohn Disease Clinical Trial
Official title:
A Prospective Observational Study of ENTYVIO Management in Crohn's Disease in Canada: Real-World Experience and Patient-Reported Outcomes
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.
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.
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