NCT00206648已完成4 期
A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 271
- 主要终点
- Time to onset of first relapse
研究概览
简要总结
The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.
详细描述
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RRMS patients that are receiving treatment with Avonex 30 µg once weekly
排除标准
- •Primary Progressive or Secondary Progressive MS
研究组 & 干预措施
Arm 1
Experimental
干预措施: Betaferon/Betaseron (Drug)
Arm 2
Active Comparator
干预措施: Betaferon/Betaseron (Drug)
结局指标
主要结局
Time to onset of first relapse
时间窗: Time to onset of first relapse
次要结局
- Number of patients relapse free at week 104(At week 104)
研究者
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