Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)
研究概览
简要总结
The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.
This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under the age of 18 years,
- •Patients diagnosed with CD.
- •Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.
排除标准
- •* There will be no exclusion criteria to this study.
研究组 & 干预措施
Risankizumab
Induction regimen: 0,4,8 IV and then every 8 weeks sc
干预措施: Risankizumab (Drug)
结局指标
主要结局
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)
时间窗: Through study completion, approximately 3 years
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) as defined by the fulfilment of all three criteria: i. Corticosteroids and enteral nutrition free ii. Clinical remission (i.e. PCDAI\<10) iii. CRP lower than 1 mg/dl (may be substituted by ESR if CRP missing)
次要结局
未报告次要终点
研究者
Prof. Amit Assa
Pediatric Gastroenterologist, Principal Investigator
Shaare Zedek Medical Center