Assessment of Safety and Efficacy of Vedolizumab in Pediatric Uclerative Colitis in Comparison With Standard Biological Therapy With Infliximab
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Safety of biological treatment with vedolizumab and infliximab assessed/defined by the number of drug-related adverse events (AEs).
研究概览
简要总结
This is a multicenter, double-blind, randomized study to compare the safety, effectiveness and immunogenicity (antibodies against drug) of two biological drugs administered intravenously - vedolizumab (a drug not registered in pediatric patients) and infliximab (used as standard therapy), in pediatric patients with UC aged 6-18 years.
Before enrollment to the study, informed consent must be obtained from the participant's legal guardian and, additionally, from the participant aged >16 years before any procedures are performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Allocation to therapeutic subgroups will be in a 1:1 ratio.
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Infliximab arm
Patients meeting the inclusion criteria and not having any of the exclusion criteria will be randomized 1:1 to one of two study arms - intravenous administration of blinded active drug, infliximab or vedolizumab at weeks 0, 2, 6 and 14. Infliximab will be administered at a dose 5mg/kg body weight, and vedolizumab at a dose of 300 mg (body mass > 40 kg) and 10 mg/kg (body mass < 40kg).
干预措施: Infliximab (Drug)
Vedolizumab arm
Patients meeting the inclusion criteria and not having any of the exclusion criteria will be randomized 1:1 to one of two study arms - intravenous administration of blinded active drug, infliximab or vedolizumab at weeks 0, 2, 6 and 14. Infliximab will be administered at a dose 5mg/kg body weight, and vedolizumab at a dose of 300 mg (body mass > 40 kg) and 10 mg/kg (body mass < 40kg).
干预措施: Infliximab (Drug)
结局指标
主要结局
Safety of biological treatment with vedolizumab and infliximab assessed/defined by the number of drug-related adverse events (AEs).
时间窗: screening - Week 20
Information on AEs will be collected on each check-up visit, physical examination, vital signs and lab test will be performed
次要结局
未报告次要终点
研究者
JAROSLAW KIERKUS
Children's Memorial Health Institute
Children's Memorial Health Institute, Poland