Actively Recruiting
Post-Marketing Surveillance of Vedolizumab Subcutaneous Injection in 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing adult participants in South Korea who have moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). These participants have not responded well, lost response, or experienced intolerable side effects from conventional therapy or TNF-alpha antagonists. The study aims to evaluate the safety and effectiveness of vedolizumab given as a subcutaneous injection in routine clinical practice under real-world conditions. The study will include about 600 participants who have started treatment with vedolizumab subcutaneously after showing therapeutic benefit from at least two intravenous infusions. All participants will be observed in a single group for a period of 52 weeks. This post-marketing surveillance study will collect data prospectively from medical records and record it electronically at multiple centers across South Korea over approximately six years. During the study, researchers will review safety outcomes such as serious adverse events, adverse drug reactions, and unexpected side effects up to week 52. They will also assess effectiveness by measuring clinical response, remission, and mucosal healing in participants with UC and CD. There is no new treatment given as part of this study; it only collects information from current medical care. Participants' health information will be monitored throughout the study period to better understand vedolizumab's use in real-world settings.
CONDITIONS
Brief 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
- Had inadequate response, lost response, or intolerance to conventional therapy or TNF-alpha antagonist
- Evidence of therapeutic benefit after at least two vedolizumab intravenous infusions
You will not qualify if you...
- History of hypersensitivity reactions such as breathing difficulty, bronchospasm, rash, flushing, or increased heart rate to vedolizumab or its ingredients
- Active severe infections including 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 52 weeks
Participants who have started vedolizumab treatment in routine clinical practice are observed prospectively for safety and effectiveness under real-world conditions.
Visits as part of routine clinical practice over 52 weeks
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
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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