International, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Number of Combined Unique Active Lesions
研究概览
简要总结
Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years. Study hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original drug Rebif®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders with Multiple Sclerosis (McDonald criteria 2010)
- •No relapses 28 days before randomisation
- •Expanded Disability Status Scale score 0-5,5
- •Exclusion Criteria
- •Primary or secondary progression of Multiple Sclerosis
- •Expanded Disability Status Scale score more then 5,5
- •Severe depression, suicide ideas and/or attempts
- •Systemic corticosteroid application in 30 days before randomisation
排除标准
- 未提供
研究组 & 干预措施
BCD-033
Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks
干预措施: BCD-033 (interferon beta 1a) (Drug)
Rebif
Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage
干预措施: Rebif (interferon beta 1a) (Drug)
Placebo
Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 48 weeks, followed by 72 weeks of open-label BCD-033 usage
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Combined Unique Active Lesions
时间窗: 52 weeks
Number of Combined Unique Active Lesions (CUA) -- the number of new MRI contrast uptake lesions on T1 images, and new or expanding lesions on T2 images (lesion identified on T1-and T2 images is not counted twice) after 52 weeks blinded application of interferon-β1а (BCD-033 and Rebif®) (44 mcg).
次要结局
- Proportion of Subjects Without Confirmed Relapse(16, 52 weeks)
- Annual Relapse Rate(96 week)
- Number of Combined Unique Active Lesions(16 weeks)
- Relapse Free Time(16, 52 weeks)