NCT05428345

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition. This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group: • Participants with UC or CD This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.

Conditions

• Ulcerative Colitis
• Crohn's Disease
• Inflammatory Bowel Disease (IBD)

Timeline

• Start date: 2023-09-25
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2022-06-23
• Last updated: 2025-10-06

Locations

1 site across 1 country: South Korea