Trials / Completed
CompletedNCT03535649
A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis Korean Patients: a Multicenter Post-marketing Observational Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 105 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
Detailed description
This is a post-marketing, non-interventional study of participants with moderate to severe UC. The study will review medical records of participants who have initiated medical treatment with vedolizumab intravenous during the defined eligibility period under routine clinical practice to provide the real world data on the effectiveness and safety of vedolizumab intravenous. The study will enroll approximately 100 participants. All participants will be enrolled in one observational group: Vedolizumab Both retrospective and prospective data will be collected in the index period, with prospective data collected for treatment baseline visit and follow up visits. The multi-center trial will be conducted in Republic of Korea. The overall duration of study will be approximately 15 months.
Conditions
Timeline
- Start date
- 2017-08-17
- Primary completion
- 2018-12-18
- Completion
- 2018-12-18
- First posted
- 2018-05-24
- Last updated
- 2019-12-23
- Results posted
- 2019-12-23
Locations
15 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03535649. Inclusion in this directory is not an endorsement.