LBCTR2021034775已完成3 期
A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy
ovartis Pharma Services Inc.0 个研究点目标入组 15 人开始时间: 2024年5月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 至 60（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Diagnosis of multiple sclerosis (MS)
- •Relapsing MS (RRMS or SPMS) course
- •Subject transitioning from either fingolimod or dimethyl fumarate, following min 6 months treatment with either drug
- •Breakthrough disease as evidence by clinical relapses or MRI
- •EDSS score of 0 to 4
排除标准
- •Primary progressive MS or SPMS without disease activity
- •Disease duration of more than 10 years since diagnosis
- •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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