Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)
NCT ID: NCT03942120
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
685 participants
OBSERVATIONAL
2019-04-08
2022-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with Crohn's Disease
Participants that are diagnosed with Crohn's disease will be observed in this study who are being treated with ustekinumab under real world clinical practice. Only data available per clinical practice will be collected within this study.
Ustekinumab
Participants treated with ustekinumab under real world clinical practice will be observed in this study. No study drug will be administered as a part of this study.
Interventions
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Ustekinumab
Participants treated with ustekinumab under real world clinical practice will be observed in this study. No study drug will be administered as a part of this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Janssen Korea, Ltd., Korea
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Korea, Ltd., Korea Clinical Trial
Role: STUDY_DIRECTOR
Janssen Korea, Ltd., Korea
Locations
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Inje University Busan Paik Hospital
Busan, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Good Gangan Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Dong-A University Hospital
Busan, , South Korea
Samsung ChangWon Hospital
Changwon, , South Korea
Changwon Kyunngsang University Hospital
Changwonsi, , South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, , South Korea
Dankook University Hospital
Cheonan-si, , South Korea
Hallym University Chuncehon Medical Center
Chuncheon, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Daegu Fatima Hospital
Daegu, , South Korea
Kyongpook national university Medical center
Daegu, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Koo Hospital
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chunnam National University Hospital
Gwangju, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , South Korea
GyeongSang National University Hospital
Jinju, , South Korea
Bucheon Soonchunhyang Hospital
Kyunggido, , South Korea
The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital
Seongnam, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam, , South Korea
Pusan National University Yangsan Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Soonchunhyang University Seoul Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hallym University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
KyungHee University Hospital
Seoul, , South Korea
Yonsei University Severance Hospital - Dept.of Internal Medicine
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Ewha Woman's University Seoul Hospital
Seoul, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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References
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Lee CK, Moon W, Chun J, Kim ES, Kim HW, Yoon H, Kim HS, Lee YJ, Choi CH, Jung Y, Park SC, Song GA, Lee JH, Jung ES, Kim Y, Jung SY, Choi JM, Ye BD. One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn's Disease: The K-STAR Study. Inflamm Bowel Dis. 2025 May 12;31(5):1306-1316. doi: 10.1093/ibd/izae171.
Other Identifiers
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CNTO1275CRD4029
Identifier Type: OTHER
Identifier Source: secondary_id
CR108610
Identifier Type: -
Identifier Source: org_study_id
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