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

Launched by TAKEDA · Jun 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called vedolizumab, which is given as an injection just under the skin, on adults in South Korea who have moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). The main goal is to see how well this treatment works for people who haven't had good results from other therapies or who have experienced too many side effects. Researchers will collect information from medical records to understand the benefits and any side effects related to vedolizumab.

To be eligible for this study, participants must be adults aged 18 and older with active UC or CD who have not responded well to previous treatments. They should also have shown some improvement after receiving at least two previous intravenous doses of vedolizumab. It's important to note that there is no new treatment being given in this study; instead, it is an observational review. Anyone interested in participating should be aware that those with certain allergies or serious infections may not qualify.

Gender

ALL

Eligibility criteria

• 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-α 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