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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Percentage of Participants With Endoscopic Remission at Week 24
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Ustekinumab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Endoscopic Remission at Week 24
Time Frame: Week 24
Endoscopic remission: simple endoscopic score for crohn's disease (SES-CD) less than or equal to (\<=) 2, total SES-CD \<=4, a decrease in total SES-CD greater than or equal to (\>=) 2 from baseline, and no subtotal SES-CD \>1 for each endoscopic parameter (for isolated ileal, ileocolonic and isolated colonic CD), rutgeerts score \<=i1 (for post-operation CD). SES-CD: assesses disease severity based on 4 endoscopic parameters across 5 ileocolonic segments. Total SES-CD = 0 to 56,higher scores = more severe disease. Rutgeerts score: assess postoperative disease recurrence with no lesions (i0); \<=5 aphthous lesions (i1); \>5 aphthous ulcers with normal intervening mucosa/patchy areas of larger lesions/lesions confined to ileocolic anastomosis (i2); diffuse aphthous ileitis and diffusely inflamed mucosa (i3); diffuse inflammation with large ulcers, nodules, and/or stenosis (i4).
Secondary Outcomes
- Percentage of Participants With Clinical Response at Week 24(Week 24)
- Percentage of Participants With Steroid-free Clinical Remission at Week 24(Week 24)
- Percentage of Participants With Steroid-free Clinical Response at Week 24(Week 24)
- Percentage of Participants With Endoscopic Response at Week 24(Week 24)
- Percentage of Participants With Clinical Remission at Week 24(Week 24)
- Change From Baseline in C-Reactive Protein (CRP) at Week 24(Baseline and Week 24)
- Percentage of Participants With Disease Progression(From index date up to death or end of study (up to 34.4 months))
- Change From Baseline in Fecal Calprotectin at Week 24(Baseline and Week 24)
- Time to Disease Progression(From index date up to death or end of study (up to 34.4 months))
- Percentage of Participants With Ustekinumab Therapy Switch During the Observational Period to Other Therapy(From index date up to death or end of study (up to 34.4 months))
- Percentage of Participants With Reasons for Ustekinumab Therapy Switch to Other Therapy(From index date up to death or end of study (up to 34.4 months))
- Percentage of Participants With Reasons for Ustekinumab Therapy Discontinuation(From index date up to death or end of study (up to 34.4 months))
- Time to Ustekinumab Therapy Switch or Discontinuation(From index date up to death or end of study (up to 34.4 months))
- Percentage of Participants With Each Adverse Event (AE)(From index date up to death or end of study (up to 34.4 months))
- Percentage of Participants With Ustekinumab Therapy Discontinuation(From index date up to death or end of study (up to 34.4 months))
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From index date up to death or end of study (up to 34.4 months))
- Duration of Each Adverse Event (AE)(From index date up to death or end of study (up to 34.4 months))
- Percentage of Participants With Each AE's Outcome(From index date up to death or end of study (up to 34.4 months))
- Percentage of Participants With Ustekinumab Therapy Switch or Discontinuation due to AEs(From index date up to death or end of study (up to 34.4 months))