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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Page 1 of 1 (3 locations)

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