Actively Recruiting
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Led by Takeda · Updated on 2025-10-06
600
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with moderately to severely active ulcerative colitis or Crohn's disease
- History of inadequate response, loss of response, or intolerance to conventional therapy or TNF-alpha antagonists
- Evidence of therapeutic benefit after at least two vedolizumab intravenous infusions
You will not qualify if you...
- Hypersensitivity to vedolizumab or its excipients, including symptoms like dyspnea, bronchospasm, urticaria, flushing, or increased heart rate
- Active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis, or opportunistic infections like Progressive Multifocal Leukoencephalopathy (PML)
- Contraindication to vedolizumab subcutaneous injection as per product label
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea, 10326
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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