Trials / Withdrawn
WithdrawnNCT04349449
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
A Prospective Observational Study of ENTYVIO Management in Crohn's Disease in Canada: Real-World Experience and Patient-Reported Outcomes
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2020-09-30
- Primary completion
- 2022-11-30
- Completion
- 2022-11-30
- First posted
- 2020-04-16
- Last updated
- 2020-10-06
Locations
14 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT04349449. Inclusion in this directory is not an endorsement.