Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 20
- 主要终点
- Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occurring during or within 24 hours of LEMTRADA infusion.
研究概览
简要总结
Primary Objective:
To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion associated reactions.
详细描述
The total duration of participation in the study per patient is approximately 13.5 months.
After the end of the second course of LEMTRADA treatment, patients will be followed by their physician in a regular healthcare setting until 48 months safety monitoring period is completed.
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
- 18 Years 至 —（Adult, Older Adult）
- 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
GZ402673 LEMTRADA
First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
干预措施: aciclovir (Drug)
GZ402673 LEMTRADA
First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
干预措施: Alemtuzumab GZ402673 (Drug)
GZ402673 LEMTRADA
First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
干预措施: cetirizine (Drug)
GZ402673 LEMTRADA
First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
干预措施: ranitidine (Drug)
GZ402673 LEMTRADA
First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
干预措施: methylprednisolone (Drug)
GZ402673 LEMTRADA
First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
干预措施: esomeprazole (Drug)
GZ402673 LEMTRADA
First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
干预措施: ibuprofen (Drug)
GZ402673 LEMTRADA
First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
干预措施: paracetamol (Drug)
结局指标
主要结局
Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occurring during or within 24 hours of LEMTRADA infusion.
时间窗: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion by type (as defined by clinical symptoms)
时间窗: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion of IARs
时间窗: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion and type of serious IARs
时间窗: up to 30 days in the first treatment course and the second treatment course, respectively
次要结局
未报告次要终点