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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

Recruitingn/aAges 18 Years - anyAllTakeda
NCT05428345 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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-ฮฑ) 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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. With moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-ฮฑ antagonist 2. With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions Exclusion Criteria: 1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients 2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML) 3. For whom vedolizumab SC is contraindicated as per product label
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What it tests

  • Not listed
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Where

1 site
Donggguk University Ilsan Hospital
Goyang-si, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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