EUCTR2014-000917-30-BE进行中（未招募）不适用
A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 113
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
- •- Must have documented diagnosis of RMS at screening.
- •- Must fall within the therapeutic indications stated in the locally approved label for natalizumab.
- •- Must have an EDSS score from 0 to 6.5, inclusive.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 113
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any prior use of natalizumab.
- •- Positive for anti-natalizumab antibodies at screening.
- •- Treatment with immunomodulatory injections (including IFN-ß and glatiramer acetate) within 2 weeks prior to Screening.
研究者
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