JPRN-jRCT2080223655已完成2 期
A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab
ovartis Pharma K.K.0 个研究点目标入组 30 人开始时间: 2017年9月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 55age old（—）
- 性别
- All
入选标准
- •* Diagnosis of multiple sclerosis (MS)
- •* Relapsing MS
- •* At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhanced T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization
- •* EDSS score of 0 to 5.5
排除标准
- •* Primary progressive MS or SPMS without disease activity
- •*Patients with an active chronic disease of the immune system other than MS
- •* Patients at risk of developing or having reactivation of hepatitis
- •* Patients with active systemic infections or with neurological findings consistent with PML
- •Other protocol defined inclusion/exclusion criteria may apply.
研究者
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