A Randomized, Multicenter, Parallel Group, Open-label Study Comparing the Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing Remitting MS Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 1,883
- 主要终点
- Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment
研究概览
简要总结
This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram [mcg] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.
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
- 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
- •Greater than or equal to 18 years of age
- •Has relapsing-remitting MS
- •Are willing and able to comply with the protocol for the duration of the study
排除标准
- •Has significant leukopenia/lymphopenia (white blood cell count less than (<) 0.5 times the lower limit of normal)
- •Has elevated liver function tests (aspartate aminotransferase [AST], Alanine transaminase [ALT], or alkaline phosphatase greater than (>) 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal)
- •Has an allergy to human serum albumin or mannitol
- •Had treatment with an investigational product or procedure within 3 months
- •Has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study
- •Has concomitant use of Avonex®, Betaseron®, Copaxone®, or Novantrone®
研究组 & 干预措施
Rebif® with Rebiject™Mini
干预措施: Rebif® via Rebiject™Mini (Device)
Rebif® without Rebiject™Mini
干预措施: Rebif® via manual injections (Device)
结局指标
主要结局
Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment
时间窗: Month 3
次要结局
- Number of subjects with any injection site reactions based on physician assessment(Month 3)
- Percentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports(Baseline up to Month 3)
- Percentage of injection site reactions reported per subject based on subject reports(Baseline up to Month 3)