Clinical trial NCT06082986: A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will consist of bio-naive participants who initiated ustekinumab therapy for the first time between 20 May 2020 and 16 September 2022.

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Endoscopic Remission at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With Endoscopic Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Clinical Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Clinical Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Steroid-free Clinical Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Steroid-free Clinical Response at Week 24
timeFrame: Week 24
measure: Change From Baseline in C-Reactive Protein (CRP) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Fecal Calprotectin at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Disease Progression
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Time to Disease Progression
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Percentage of Participants With Ustekinumab Therapy Switch During the Observational Period to Other Therapy
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Percentage of Participants With Reasons for Ustekinumab Therapy Switch to Other Therapy
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Percentage of Participants With Ustekinumab Therapy Discontinuation
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Percentage of Participants With Reasons for Ustekinumab Therapy Discontinuation
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Time to Ustekinumab Therapy Switch or Discontinuation
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Percentage of Participants With Each Adverse Event (AE)
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Duration of Each Adverse Event (AE)
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Percentage of Participants With Each AE's Outcome
timeFrame: From index date up to death or end of study (up to 34.4 months)
measure: Percentage of Participants With Ustekinumab Therapy Switch or Discontinuation due to AEs
timeFrame: From index date up to death or end of study (up to 34.4 months)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine
state: Zhejiang
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: