N/A
Completed N=105
A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT03535649 ↗
Enrolled (actual)
105
Serious AEs
4.8%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score — 55.8 percentage of participants
Summary
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score |
55.8 | — |
| PRIMARY Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs) |
4.76; 4.76 | — |
| PRIMARY Percentage of Participants With Pregnancy During the Study |
0.00 | — |
| SECONDARY Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score |
73.2 | — |
| SECONDARY Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score |
18.2; 39.4 | — |
| SECONDARY Percentage of Participants With Mucosal Healing at Weeks 6 and 14 |
22.2; 49.2 | — |
Eligibility Criteria
Inclusion Criteria
- Moderately to severely active UC and having failed TNF-alpha antagonist therapy.
Exclusion Criteria
- Was treated with vedolizumab intravenous outside of the locally approved label in South Korea.
- Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.
Data sourced from ClinicalTrials.gov (NCT03535649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.