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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Crohn Disease

Treatments: Drug: Ustekinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06082986

CR109344

PCSIMMA0055 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Bio-naive Participants With Crohn's Disease (CD)

Description:

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.

Treatment:

Drug: Ustekinumab