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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799496
• Other study ID #: Vedolizumab-4023
• Status: Recruiting
• Start date: June 10, 2020
• Est. completion date: January 14, 2026

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 14, 2026
• Est. primary completion date: January 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcer

Locations

Country	Name	City	State
Korea, Republic of	Soon Chunhyang University Hospital Bucheon	Bucheon
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Good Gang-An Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Hallym Univ. Medical Center	Chuncheon
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Daegu Patima Hospital	Daegu
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Koo Hospital	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Hanyang University Medical Center	Gyeonggi-do
Korea, Republic of	Inje University Ilsan Paik Hospital	Gyeonggi-do
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Bucheon ST. Marys Hospital	Gyeonggi-do
Korea, Republic of	DongGuk University International Hospital	Ilsan
Korea, Republic of	Ilsan Paik Hospital	Ilsan
Korea, Republic of	Jeonbuk National University Hospital	Jeonju
Korea, Republic of	CHA University Bundang Medical Center	Seongnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul
Korea, Republic of	Kyunghee University Hospital at Gangdong	Seoul
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St.Mary's Hospital	Seoul
Korea, Republic of	Seoul St.Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ulsan university Hospital	Ulsan
Korea, Republic of	Wonju Severance Christian Hospital	Wonju
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Serious Adverse Events (SAEs)		Baseline up to 56 weeks
Primary	Percentage of Participants With Adverse Drug Reactions (ADRs)		Baseline up to 56 weeks
Primary	Percentage of Participants With Serious Adverse Drug Reactions (SADRs)		Baseline up to 56 weeks
Primary	Percentage of Participants With Adverse Events of Special Interest (AESIs)		Baseline up to 56 weeks
Primary	Percentage of Participants With Unexpected Adverse Events (AEs)		Baseline up to 56 weeks
Primary	Percentage of Participants With Unexpected ADRs		Baseline up to 56 weeks
Secondary	Percentage of Participants With Clinical Response	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
Secondary	Percentage of Participants With Clinical Remission	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
Secondary	Percentage of Participants With Mucosal Healing	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

External Links

•   To obtain more information on the study, please click on this link.