A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China

Sponsor
Xian-Janssen Pharmaceutical Ltd.
Study ID
NCT06082986
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    No interventions will be administered as a part of this study. Participants received ustekinumab as per their routine clinical practice.

Study Details

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 remission at week 24 among bio-naive participants with CD treated with ustekinumab in China.

Key Dates

Start date
Oct 9, 2023
Status verified
Jun 2025
Primary completion
Jun 5, 2024
Completion
Jun 5, 2024

Study Design

Enrollment
200 participants (actual)

Arms

  • Arm: Bio-naive Participants With Crohn's Disease (CD)
    Participants with CD from inflammatory bowel disease (IBD) database who received ustekinumab from 20 May 2020 to 16 September 2022 in the real-world setting in China will be observed in the study. Only data available per routine clinical practice will be collected within this study.

Primary Outcome Measure

Percentage of Participants With Endoscopic Remission at Week 24 [ Time Frame: Week 24 ]

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