A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
- Conditions
- Colitis, Ulcerative
- Registration Number
- NCT03535649
- Lead Sponsor
- Takeda
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- Moderately to severely active UC and having failed TNF-alpha antagonist therapy.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score Week 6 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.
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
Name Time Method Percentage of Participants With Mucosal Healing at Weeks 6 and 14 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.
Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score Weeks 6 and 14 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.
Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score Week 14 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.
Trial Locations
- Locations (15)
Goo Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan-si, Chungcheongnam-do, Korea, Republic of
The Catholic University of Korea, Daejeon St. Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Youngnam University Hospital
🇰🇷Daegu, Korea, Republic of
Inje University Haeundae Paik Hospita
🇰🇷Busan, Korea, Republic of