EUCTR2015-005418-31-HR进行中（未招募）1 期
A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
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 or female patients aged 18 to 55 years (inclusive) at screening
- •Diagnosis of MS according to the 2010 Revised McDonald criteria
- •Relapsing form of MS: relapsing-remitting course (RRMS), or secondary progressive course with disease activity (relapsing SPMS)
- •Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
- •At least 1 documented relapse during the previous 1 year OR at least 2 documented relapses during the previous 2 years OR a positive GdE MRI scan during the year prior to randomization and including screening.
- •Neurologically stable within 1 month prior to randomization
- •Please see protocol for complete detailed list of inclusion criteria
- •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 900
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with primary progressive MS or SPMS without disease activity
- •Disease duration of more than 10 years in patients with EDSS score of 2 or less
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential not using highly effective contraception
- •Patients with an active chronic disease
- •Patients with active systemic infections, or history of or known presence of recurrent or chronic infection
- •Have received any live or live-attenuated vaccines within 2 months prior to randomization
- •Have been treated with medications as specified within the timeframes specified (e.g. ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, teriflunomide, etc)
- •Any other disease or condition which could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.
- •Please see protocol for complete detailed list of exclusion criteria
研究者
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