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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-09

Study Completion Date

2024-06-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Ustekinumab

Intervention Type DRUG

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

Interventions

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Ustekinumab

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No