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A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Sponsor: Takeda
Summary
The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.
Official title: Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2023-09-25
Completion Date
2027-11-30
Last Updated
2025-10-06
Healthy Volunteers
No
Locations (1)
Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea