NCT00097760已完成2 期
Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 110
- 主要终点
- Rate of development of new active lesions on MRI scans.
研究概览
简要总结
The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).
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
- Triple (Participant, 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
- •Diagnosis of MS as defined by McDonald et al., criteria # 1-4
- •Between the ages of 18 and 55, inclusive
- •Baseline EDSS score between 0.0 and 5.0, inclusive
- •Have been treated with GA for at least the 12 months prior to randomization
排除标准
- •Primary progressive, secondary progressive or progressive relapsing MS
- •MS relapse has occurred within the 50 days prior to randomization
- •A clinically significant infectious illness
- •History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.
研究组 & 干预措施
Group 2
Placebo Comparator
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
干预措施: Placebo (Drug)
Group 1
Experimental
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
干预措施: Natalizumab (Drug)
结局指标
主要结局
Rate of development of new active lesions on MRI scans.
时间窗: Week 20
次要结局
- Incidence and severity of adverse events.(Week 20)
研究者
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