NCT06082986Completed
A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China
A Multicenter, Retrospective, Observational Study Using Real-world Data to Describe the Effectiveness, Treatment Pattern and Safety of Ustekinumab Among Bio-naive Patients With Crohn's Disease in China
Source: ClinicalTrials.gov · Last updated 26 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 9 Oct 2023
- Start date
- 9 Oct 2023
- Primary completion date
- 5 Jun 2024
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Diseases
- Crohn's disease
- NCT number
- NCT06082986
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 9 Oct 2023 to the primary completion date, 5 Jun 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital,affiliated with Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.