Open Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 39
- 主要终点
- Difference Between the Number of Newly Active Lesions in Magnetic Resonance Imaging (MRI) Per Three Months During the 6-month Treatment Period and the Number of Newly Active Lesions During 3-month Pre-treatment
研究概览
简要总结
The purpose of this study is to determine if the study drug is effective and safe in the treatment of Multiple Sclerosis (MS) in patients of Chinese origin.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany.
Bayer HealthCare AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese origin
- •diagnosis of Relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis
排除标准
- •Any disease other than Multiple Sclerosis (MS) that could better explain the patients signs and symptoms
- •HIV (human immunodeficiency virus) infections
- •Hepatitis A
- •immunodeficiency
- •rheumatic disease or Sjogren syndrome
- •heart disease
- •severe depression
- •pregnancy or lactation
- •conditions interfering with Magnetic Resonance Imaging (MRI)
- •Gadolinium DTPA (Gadovist, contrast agent) allergy
- •allergy against human proteins, paracetamol, acetaminophen and ibuprofen intolerance
- •participation in other trial
研究组 & 干预措施
Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
Difference Between the Number of Newly Active Lesions in Magnetic Resonance Imaging (MRI) Per Three Months During the 6-month Treatment Period and the Number of Newly Active Lesions During 3-month Pre-treatment
时间窗: after 6 months of treatment as compared to 3-month pre-treatment
The primary efficacy variable was calculated by subtracting the number of newly active lesions during the 3-month pre-treatment period from the cumulative number of newly active lesions during the 6-month treatment period divided by 2 (number of newly active lesions per three months, new lesion frequency per 3 months)
次要结局
- Difference Between the Number of New or Enlarging T2 Lesions Per 3 Months During the 6-month Treatment Period and the Number of New or Enlarging T2 Lesions During 3-month Pre-treatment(after 6 months of treatment as compared to the 3-month pre-treatment)
- Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks(After 24 weeks)
- Difference Between the Number of New Gadolinium (Gd)-Enhancing Lesions Per 3 Months During the 6-month Treatment Period and the Number of New Gd-enhancing Lesions During 3-month Pre-treatment(after 6 months of treatment as compared to 3-month pre-treatment)
- Assessment of Relapses: Relapse Rate(Baseline up to Week 24)
- Assessment of Relapses: Relapse Severity(Baseline up to Week 24)
- Percentage of Subjects Without EDSS Progression(Baseline up to Week 24)
- Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24(Baseline, Weeks 12 and 24)
- Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24(Baseline, Weeks 12 and 24)
- Assessment of Relapses: Number of Relapses(3 and 6 months)
- Number of T2 Lesions at Baseline, Weeks 12 and 24(Baseline, Weeks 12 and 24)
- Expanded Disability Status Scale (EDSS)(Pre-treatment on Day 1, Week 24)