Trial Details

None
Basic Information
Clinical ID c2416
Identifier KCT0006087
Trial Title Efficacy and Safety of vedolizumab in biologic-name Korean patients with moderate to severe inflammatory bowel disease
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions ;Diseases of the digestive system
Interventions Drug : The subjects to be recruited consist of 30 patients with Crohn's disease and 30 patients with ulcerative colitis (considering dropout rate of 20%). Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks.
Participant Information
Sponsor Yonsei University Health System, Severance Hospital
City -
Country/Region South Korea
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, OLDER_ADULT
Study Design
Study Type Interventional Study
Phase PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -