Real-world Evidence for the Effectiveness and Safety of Ustekinumab Treatment in Children With Crohn's Disease: A Retrospective Cohort Study Using the ImproveCareNow Registry Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 545
- 试验地点
- 1
- 主要终点
- Cohort 1: Percentage of Pediatric Participants with Clinical Remission at Week 52
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of ustekinumab in achieving clinical remission in pediatric participants (greater than or equal to [>=] 2 to less than [<] 18 years and weight >= 40 kilograms [kg] at baseline).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having at least one ICN visit with documented new use of ustekinumab
- •Participants with a documented Crohn's disease (CD) diagnosis at the time ustekinumab was initiated (that is, Baseline); If diagnosis at baseline is missing, then the diagnosis from previous visit within study window will be utilized
- •Having at least one ICN visit prior to the ICN visit when ustekinumab is first documented
- •Having received first dose of ustekinumab on or before June 22, 2019
- •Having provided informed consent for use of ICN data for research purposes
排除标准
- •Documented exposure to ustekinumab before enrollment in ICN (by chart review)
研究组 & 干预措施
Participants with Crohn's Disease (CD)
Participants with moderate-to-severe active CD enrolled in ImproveCareNow (ICN) pediatric Inflammatory bowel disease (IBD) registry will be observed who are being treated with ustekinumab under real world setting and will be divided into 9 cohorts. Cohorts 1-6 for age group >=2 to <18 years (pediatric), cohorts 7-9 for young adults within age group >=18 to <26 years. Cohort 1: participants with moderate-severe CD and body weight >=40 kg, cohort 2: participants with moderate-severe CD and body weight <40 kg, cohort 3: all participants with moderate-severe CD, cohort 4: participants with active disease and body weight >=40 kg, cohort 5: participants with active disease and body weight <40 kg, cohort 6: all participants treated with ustekinumab, cohort 7: young adults with moderate-severe CD, cohort 8: young adults with active-disease; and cohort 9: all young adults treated with ustekinumab. Only data available per routine clinical practice will be collected within this study.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Cohort 1: Percentage of Pediatric Participants with Clinical Remission at Week 52
时间窗: Week 52
Percentage of Pediatric participants with clinical remission at Week 52 will be reported. Clinical remission is defined by short pediatric Crohn's disease activity index (sPCDAI) less than or equal to (\<=) 10.
次要结局
- Cohorts 1 and 7: Percentage of Participants with Occurrence of IBD-related Surgeries Who had Initiated Ustekinumab Therapy(Up to Week 52)
- Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 with No Corticosteroid Use(Week 52)
- Cohorts 1 and 7: Percentage of Participants Who Achieve Endoscopic Remission with SEMA-CD Score of 0 or 1 at Week 52(Week 52)
- Cohorts 1 and 7: Percentage of Participants with Occurrence of Inflammatory Bowel Diseases (IBD)-related Hospitalizations Who had Initiated Ustekinumab Therapy(Up to Week 52)
- Cohort 7: Percentage of Young Adult Participants with Clinical Remission at Week 52(Week 52)
- Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 Evaluated by Ustekinumab Dose Bands(Week 52)
- Cohorts 1 and 7: Percentage of Participants that Discontinued Ustekinumab Use Among Participants who Initiated Ustekinumab Therapy at Week 52(Week 52)
- Cohorts 1 and 7: Percentage of Participants with Adverse Events of Special Interest (AESI) Who had Initiated Ustekinumab Therapy(Up to Week 52)
- Cohorts 2, 3, 4, 5, 6, 8 and 9: Percentage of Participants with Clinical Remission at Week 52(Week 52)
- Cohorts 1 and 7: Change from Baseline in Height at Week 52(Baseline and Week 52)
- Cohorts 1 and 7: Change from Baseline in Weight at Week 52(Baseline and Week 52)
- Cohorts 1 and 7: Change from Baseline in Body Mass Index (BMI) at Week 52(Baseline and Week 52)
- Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 by PGA Score(Week 52)
- Cohorts 1 and 7: Change from Baseline to Week 52 in Mucosal Disease Activity Measured with SEMA-CD Score(Baseline to Week 52)