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

Status: Active_not_recruiting
Location: See all (43) locations...
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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.

Locations
Other Locations
Republic of Korea
Soon Chunhyang University Hospital Bucheon
Bucheon-si
Dong-A University Hospital
Busan
Good Gang-An Hospital
Busan
Inje University Busan Paik Hospital
Busan
Inje University Haeundae Paik Hospital
Busan
Kosin University Gospel Hospital
Busan
Pusan National University Hospital
Busan
Soonchunhyang University Cheonan Hospital
Cheonan
Chungbuk National University Hospital
Cheongju-si
Hallym Univ. Medical Center
Chuncheon
Kangwon National University Hospital
Chuncheon
Daegu Patima Hospital
Daegu
Keimyung University Dongsan Hospital
Daegu
Koo Hospital
Daegu
Kyungpook National University Chilgok Hospital
Daegu
Kyungpook National University Hospital
Daegu
Yeungnam University Medical Center
Daegu
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Chosun University Hospital
Gwangju
Hanyang University Medical Center
Gyeonggi-do
Inje University Ilsan Paik Hospital
Gyeonggi-do
Korea University Ansan Hospital
Gyeonggi-do
The Catholic University of Korea, Bucheon ST. Marys Hospital
Gyeonggi-do
DongGuk University International Hospital
Ilsan
Ilsan Paik Hospital
Ilsan
Jeonbuk National University Hospital
Jeonju
CHA University Bundang Medical Center
Seongnam
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Chung-Ang University Hospital
Seoul
Gangnam Severance Hospital
Seoul
Inje University Sanggye Paik Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
KyungHee University Hospital
Seoul
Kyunghee University Hospital at Gangdong
Seoul
Nowon Eulji Medical Center, Eulji University
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul St.Mary's Hospital
Seoul
Severance Hospital
Seoul
Ulsan university Hospital
Ulsan
Wonju Severance Christian Hospital
Wŏnju
Pusan National University Yangsan Hospital
Yangsan
Time Frame
Start Date: 2020-06-10
Completion Date: 2026-01-14
Participants
Target number of participants: 600
Treatments
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.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov