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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Kelowna GI Associates
Kelowna, British Columbia, Canada
Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada
The Winnipeg Clinic
Winnipeg, Manitoba, Canada
REGIONAL HEALTH AUTHORITY B doing business as HORIZON HEALTH NETWORK
Fredericton, New Brunswick, Canada
Nova ScotiaHealth Authority
Halifax, Nova Scotia, Canada
Barrie GI Associates
Barrie, Ontario, Canada
Lawson Health Research Institute a joint venture of London Health Science Centre Research Inc., Lawson Research Institute.
London, Ontario, Canada
Girish Bajaj MPC
Oakville, Ontario, Canada
Sinai Health System
Toronto, Ontario, Canada
Kensington Cancer Screening Clinic
Toronto, Ontario, Canada
Start Date
September 30, 2020
Primary Completion Date
November 30, 2022
Completion Date
November 30, 2022
Last Updated
October 6, 2020
Lead Sponsor
Takeda
NCT07245394
NCT07089420
Data Source & Attribution
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