A Study of Vedolizumab in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colitis Ulcerative
- Crohn Disease
- Inflammatory Bowel Diseases
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (UC or CD), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an TNF-alpha antagonist. This study will evaluate the safety and...
This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (UC or CD), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an TNF-alpha antagonist. This study will evaluate the safety and effectiveness of vedolizumab in a routine clinical practice setting under real world conditions. This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic case report forms (e-CRFs). This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.
Tracking Information
- NCT #
- NCT04799496
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Takeda
Get Well Soon