RecruitingNCT05428345

A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea

Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea


Sponsor

Takeda

Enrollment

600 participants

Start Date

Sep 25, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the long-term safety and effectiveness of a subcutaneous (under-the-skin) injectable form of vedolizumab — a medication that treats inflammatory bowel disease — in adults with moderate to severe ulcerative colitis or Crohn's disease in South Korea. **You may be eligible if:** - You have moderately to severely active ulcerative colitis or Crohn's disease - Your disease has not responded adequately to, or you could not tolerate, conventional therapy or anti-TNF medications - You have already shown benefit from at least 2 intravenous infusions of vedolizumab **You may NOT be eligible if:** - You have had a severe allergic reaction to vedolizumab (breathing difficulty, hives, rapid heartbeat) - You have an active serious infection such as tuberculosis, CMV, sepsis, or rare brain infection (PML) - Vedolizumab is contraindicated for you per the drug label Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Donggguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

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NCT05428345


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