A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants

Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis Korean Patients: a Multicenter Post-marketing Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Colitis, Ulcerative

Detailed Description

This is a post-marketing, non-interventional study of participants with moderate to severe UC. The study will review medical records of participants who have initiated medical treatment with vedolizumab intravenous during the defined eligibility period under routine clinical practice to provide the real world data on the effectiveness and safety of vedolizumab intravenous.

The study will enroll approximately 100 participants. All participants will be enrolled in one observational group: Vedolizumab

Both retrospective and prospective data will be collected in the index period, with prospective data collected for treatment baseline visit and follow up visits.

The multi-center trial will be conducted in Republic of Korea. The overall duration of study will be approximately 15 months.

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Paik Hospita
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of, 42415
    • Youngnam University Hospital
  • Daegu, Korea, Republic of, 42644
    • Goo Hospital
  • Daejeon, Korea, Republic of, 34943
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Seoul, Korea, Republic of, 3080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 6351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 3181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 5505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 2447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 3722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 6273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Chungcheongnam-do
    • Cheonan-si, Chungcheongnam-do, Korea, Republic of, 31116
      • Dankook University Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
      • The Catholic University of Korea, St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with moderate to severe UC, having failed TNF-alpha antagonist therapy and who have initiated treatment with vedolizumab intravenous between 17 August 2017 and up until 100 participants are enrolled.

Description

Inclusion Criteria:

1. Moderately to severely active UC and having failed TNF-alpha antagonist therapy.

Exclusion Criteria:

1. Was treated with vedolizumab intravenous outside of the locally approved label in South Korea.
2. Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Vedolizumab; Participants diagnosed with moderate to severe active UC and having failed tumor necrosis factor alpha (TNF alpha) antagonist therapy and who have initiated vedolizumab intravenous treatment between 17 August 2017 and the date when at least 100 cases are collected from approximately 15 participating sites will be observed from the date of UC diagnosis until the date when participant is enrolled into the study or until the end of treatment or death of participants or lost-to-follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score	Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.	Week 6
Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)		From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)
Percentage of Participants With Pregnancy During the Study		From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score	Clinical response was defined as a reduction of at least 3 points and a decrease of at least 30% from the baseline mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicated more severe disease.	Week 14
Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score	Clinical remission was defined as a total mayo score of less than or equal to (<=) 2 with no sub-score greater than (>) 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.	Weeks 6 and 14
Percentage of Participants With Mucosal Healing at Weeks 6 and 14	Mucosal healing was defined as Mayo endoscopic sub-score of 0 or 1 compared to baseline. Mayo score was an instrument designed to measure disease activity of UC. Endoscopic findings was a sub-score of complete Mayo score, which ranges from 0 to 3 (0= Normal or inactive disease; 1= Mild disease; 2= Moderate disease; 3= Severe disease), with higher scores indicating more severe disease.	Weeks 6 and 14

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2017
• Primary Completion (Actual): December 18, 2018
• Study Completion (Actual): December 18, 2018

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: Vedolizumab-5045; U1111-1208-5399 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No