EUCTR2010-020337-99-CZ进行中（未招募）1 期
A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I
F.Hoffmann-La Roche0 个研究点目标入组 821 人开始时间: 2010年10月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 821
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female participants between ages 18-55 with a diagnosis of relapsing multiple sclerosis
- •At least 2 documented clinical attacks within the last 2 years before screening or one clinical attack in the year before screening (but not within 30 days before screening)
- •Patients with EDSS score of 0-5.5, at Screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 800
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with other chronic disease of the immune system, malignancies or other diseases or conditions that could preclude participant from participating in the study
- •Contraindications to or intolerance of oral or i.v. corticosteroids
- •Contraindication to or intolerance of interferon beta-1a (Rebif)
- •Pregnant or nursing women
研究者
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