A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis

April 1, 2024 updated by: Takeda

Regulatory Post-Marketing Surveillance Study (Usage Results Study) of Kynteles Injection (Vedolizumab) for the Approved Indications in South Korea

In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice.

The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (ulcerative colitis (UC) or Crohn's disease (CD)), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an TNF-alpha antagonist or participants with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis (IPAA) for UC, and have had an inadequate response with, or lost response to antibiotic therapy. This study will evaluate the safety and effectiveness of Kynteles injection (Vedolizumab) in a routine clinical practice setting under real world conditions.

This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic case report forms (e-CRFs).

This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 14584
        • Recruiting
        • Soon Chunhyang University Hospital Bucheon
        • Contact:
          • Site Contact
          • Phone Number: 032-621-5114
        • Principal Investigator:
          • Changbeum Ryu
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
          • Site Contact
          • Phone Number: 051-240-7000
        • Principal Investigator:
          • Geun-Am Song
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Principal Investigator:
          • Tae-oh Kim
        • Contact:
          • Site Contact
          • Phone Number: 051-797-0114
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
          • Site Contact
          • Phone Number: 051-890-8725
        • Principal Investigator:
          • Sam-ryong Ji
      • Busan, Korea, Republic of, 49267
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:
          • Site Contact
          • Phone Number: 051-990-6900
        • Principal Investigator:
          • Won Moon
      • Busan, Korea, Republic of, 48265
        • Recruiting
        • Good Gang-An Hospital
        • Contact:
          • Site Contact
          • Phone Number: 051-625-0900
        • Principal Investigator:
          • Donghyun Lee
      • Busan, Korea, Republic of, 49201
        • Completed
        • Dong-A University Hospital
      • Cheonan, Korea, Republic of, 31151
        • Recruiting
        • Soonchunhyang University Cheonan Hospital
        • Contact:
          • Site Contact
          • Phone Number: 041-570-2114
        • Principal Investigator:
          • Yunho Jung
      • Cheongju, Korea, Republic of, 28644
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
          • Site Contact
          • Phone Number: 043-269-6030
        • Principal Investigator:
          • Soon Man Yoon
      • Chuncheon, Korea, Republic of, 24253
        • Recruiting
        • Hallym Univ. Medical Center
        • Contact:
          • Site Contact
          • Phone Number: 033-240-5000
        • Principal Investigator:
          • Chang-seok Bang
      • Chuncheon, Korea, Republic of, 24289
        • Recruiting
        • Kangwon National University Hospital
        • Contact:
          • Site Contact
          • Phone Number: 033-258-2000
        • Principal Investigator:
          • Sung Chul Park
      • Daegu, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Contact:
          • Site Contact
          • Phone Number: 053-200-3191
        • Principal Investigator:
          • Hyun Seok Lee
      • Daegu, Korea, Republic of, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Principal Investigator:
          • Jeongseok Kim
        • Contact:
          • Site Contact
          • Phone Number: 053-258-7762
      • Daegu, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
          • Site Contact
          • Phone Number: 053-200-5511
        • Principal Investigator:
          • Eunsoo Kim
      • Daegu, Korea, Republic of, 42415
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
          • Site Contact
          • Phone Number: 053-620-3835
        • Principal Investigator:
          • Kyung-ok Kim
      • Daegu, Korea, Republic of, 41199
        • Recruiting
        • Daegu Patima Hospital
        • Contact:
          • Site Contact
          • Phone Number: 053-940-7510
        • Principal Investigator:
          • ChangGeun Park
      • Daegu, Korea, Republic of, 42644
        • Completed
        • Koo Hospital
      • Daejeon, Korea, Republic of, 34943
        • Recruiting
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
        • Contact:
          • Site Contact
          • Phone Number: 042-220-9820
        • Principal Investigator:
          • Sang-beom Kang
      • Gwangju, Korea, Republic of, 61453
        • Recruiting
        • Chosun university hospital
        • Contact:
          • Site Contact
          • Phone Number: 062-220-3012
        • Principal Investigator:
          • Jun Lee
      • Gyeonggi-do, Korea, Republic of, 10380
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
          • Site Contact
          • Phone Number: 031-910-7200
        • Principal Investigator:
          • Jeong-wook Kim
      • Gyeonggi-do, Korea, Republic of, 11923
        • Active, not recruiting
        • Hanyang University Medical Center
      • Gyeonggi-do, Korea, Republic of, 14647
        • Completed
        • The Catholic University of Korea, Bucheon ST. Marys Hospital
      • Gyeonggi-do, Korea, Republic of, 15355
        • Completed
        • Korea University Ansan Hospital
      • Ilsan, Korea, Republic of, 10326
        • Completed
        • DongGuk University International Hospital
      • Ilsan, Korea, Republic of, 10380
        • Recruiting
        • Ilsan Paik Hospital
        • Contact:
          • Site Contact
          • Phone Number: 031-910-7269
        • Principal Investigator:
          • Nam-Hoon Kim
      • Jeonju, Korea, Republic of, 54907
        • Completed
        • Jeonbuk National University Hospital
      • Seongnam, Korea, Republic of, 13496
        • Recruiting
        • CHA University Bundang Medical Center
        • Contact:
          • Site Contact
          • Phone Number: 031-780-5000
        • Principal Investigator:
          • Dukhwan Kim
      • Seongnam, Korea, Republic of, 13620
        • Completed
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Site Contact
          • Phone Number: 1588-5700
        • Principal Investigator:
          • Jong Pil Im
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Site Contact
          • Phone Number: 02-3010-3181
        • Principal Investigator:
          • Byeong-deok Ye
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Site Contact
          • Phone Number: 02-3410-1927
        • Principal Investigator:
          • Sung Noh Hong
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • Chung-Ang University Hospital
        • Contact:
          • Site Contact
          • Phone Number: 1800-1114
        • Principal Investigator:
          • Changhwan Choi
      • Seoul, Korea, Republic of, 01757
        • Recruiting
        • Inje University Sanggye Paik Hospital
        • Contact:
          • Site Contact
          • Phone Number: 02-950-1466
        • Principal Investigator:
          • Jeongmin Choi
      • Seoul, Korea, Republic of, 03181
        • Active, not recruiting
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 03080
        • Completed
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 02447
        • Recruiting
        • KyungHee University Hospital
        • Contact:
          • Site Contact
          • Phone Number: 02-958-9994
        • Principal Investigator:
          • Hyojong Kim
      • Seoul, Korea, Republic of, 05278
        • Recruiting
        • Kyunghee University Hospital at Gangdong
        • Contact:
          • Site Contact
          • Phone Number: 02-440-7033
        • Principal Investigator:
          • Jae-myung Cha
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Seoul St.Mary's Hospital
        • Contact:
          • Site Contact
          • Phone Number: 1588-1511
        • Principal Investigator:
          • Young-Seok Cho
      • Seoul, Korea, Republic of, 03722
        • Completed
        • Severance Hospital
      • Seoul, Korea, Republic of, 06273
        • Completed
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 01830
        • Completed
        • Nowon Eulji Medical Center, Eulji University
      • Ulsan, Korea, Republic of, 44033
        • Recruiting
        • Ulsan University Hospital
        • Contact:
          • Site Contact
          • Phone Number: 052-250-7000
        • Principal Investigator:
          • Seungbum Lee
      • Wonju, Korea, Republic of, 26426
        • Completed
        • Wonju Severance Christian Hospital
      • Yangsan, Korea, Republic of, 50612
        • Completed
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will enroll moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist or pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.

Description

Inclusion Criteria:

  1. With moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
  2. With moderately to severely active chronic pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.

Exclusion Criteria:

  1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the Kynteles Injection (Vedolizumab) or to any of its excipients
  2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (PML)
  3. Treated with Kynteles Injection (Vedolizumab) outside of the locally approved label in South Korea.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Kynteles Injection (Vedolizumab)
Participants with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNF-α) antagonist or participants with pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy and have initiated Kynteles injection (Vedolizumab) treatment in a routine clinical practical setting in South Korea, will be observed prospectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: Baseline up to 56 weeks
Baseline up to 56 weeks
Percentage of Participants With Adverse Drug Reactions (ADRs)
Time Frame: Baseline up to 56 weeks
Baseline up to 56 weeks
Percentage of Participants With Serious Adverse Drug Reactions (SADRs)
Time Frame: Baseline up to 56 weeks
Baseline up to 56 weeks
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Time Frame: Baseline up to 56 weeks
Baseline up to 56 weeks
Percentage of Participants With Unexpected Adverse Events (AEs)
Time Frame: Baseline up to 56 weeks
Baseline up to 56 weeks
Percentage of Participants With Unexpected ADRs
Time Frame: Baseline up to 56 weeks
Baseline up to 56 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Response
Time Frame: Baseline up to 56 weeks
Clinical response: reduction of Mayo score of >=3 points and >=30 percent (%) from baseline score, with an accompanying decrease in rectal bleeding sub-score >=1 point/an absolute rectal bleeding sub-score of <=1 point in UC participants; and reduction of Crohn's Disease Activity Index (CDAI) score >=70 points from baseline score in CD participants. Mayo score consists of 4 variables: stool frequency, rectal bleeding, physician rating of disease activity, and endoscopic findings. Each graded from 0-3. Total score range of 0-12. Higher scores indicating more severity. CDAI assesses CD based on clinical signs such as number of liquid stools, intensity of abdominal pain, general wellbeing (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items. Total score ranged from 0-600 points. Higher score indicating more severity.
Baseline up to 56 weeks
Percentage of Participants With Clinical Remission
Time Frame: Baseline up to 56 weeks
Clinical remission: Mayo score <=2; no individual sub-score greater than (>) 1 point in UC; CDAI score <150 points in CD; and Modified Pouchitis Disease Activity Index (mPDAI) score <5 and reduction in overall score by greater than or equal to (>=) 2 points from baseline score in pouchitis. Mayo score consists of 4 variables: stool frequency, rectal bleeding, physician rating of disease activity, endoscopic findings. Each graded from 0-3. Total score range: 0-12. Higher scores-more severity. CDAI assesses CD based on clinical signs-number of liquid stools, intensity of abdominal pain, general wellbeing (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination, hematocrit (objective). CDAI score: sum of weighted scores for subjective and objective items. Total score:0-600 points. Higher score-more severity. mPDAI score ranges from 0-12 where <5=quiescent; 5-8=moderately active; 9-12=severely active disease.
Baseline up to 56 weeks
Percentage of Participants With Mucosal Healing
Time Frame: Baseline up to 56 weeks
Mucosal healing is defined as: the Mayo endoscopic sub-score of less than or equal to (<=) 1 point in the UC participants; and Crohn's Disease Endoscopic Index of Severity (CDEIS) score less than (<) 3.5 points in the CD participants. Mayo score consists of 4 variables: stool frequency, rectal bleeding, physician rating of disease activity, and endoscopic findings. Each graded from 0-3. Total score range of 0-12. Higher scores indicating more severity. CDEIS is an index of determining the severity of CD. The CDEIS considers rectum, sigmoid and left colon, transverse colon, right colon, ileum in terms of: deep ulcerations, superficial ulcerations, surface involved by disease and ulcerated surface measured. The presence of ulcerate and non-ulcerated stenosis will be recorded in each segment. Scale ranges from 0-44 with a higher score indicating greater severity of disease.
Baseline up to 56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Estimated)

January 14, 2026

Study Completion (Estimated)

January 14, 2026

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vedolizumab-4023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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