Status:
COMPLETED
A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Brief Summary
Bio-naive participants are defined as the participants who previously have not received any biologics for Crohn's Disease (CD).The purpose of this retrospective study is to describe the endoscopic rem...
Eligibility Criteria
Inclusion
- Participants with diagnosis of active Crohn's Disease (CD) (that is, Crohn's Disease Activity Index \[CDAI\] greater than or equal to \[\>=\] 150; Harvey-Bradshaw Index \[HBI\] \>=5; or determined by physicians)
- Participants with initiation of ustekinumab intravenous induction therapy for the first time between 20 May 2020 and 16 September 2022
Exclusion
- Previously received ustekinumab for any indication other than CD
- Participants were previously exposed with any biologics (for example: adalimumab, infliximab, vedolizumab or their biosimilars) other than ustekinumab
Key Trial Info
Start Date :
October 9 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 5 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06082986
Start Date
October 9 2023
End Date
June 5 2024
Last Update
June 26 2025
Active Locations (3)
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1
Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310000
2
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China, 510000
3
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, China, 510000