NL-OMON47697已完成3 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 - COMB157G2301
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 20
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
- 18 至 64（—）
入选标准
- •* Male or female patients aged 18 to 55 years (inclusive) at Screening
- •* Relapsing MS: relapsing-remitting course (RRMS), or secondary progressive (SPMS) course with disease activity
- •* Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
- •* Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years prior to Screening OR a positive Gd-enhancing MRI scan during the year prior to randomization
- •* Neurologically stable within 1 month prior to randomization
排除标准
- •* Patients with primary progressive MS or SPMS without disease activity
- •* Patients meeting criteria for neuromyelitis optica
- •* Disease duration of more than 10 years in patients with an EDSS score of 2 or less
- •* Women of child-bearing potential unless using highly effective methods of contraception during study drug dosing and for 12 months post-dosing
- •* Sexually active males unless they agree to use condom during intercourse while on study drug
- •* Patients at risk of developing or having reactivation of hepatitis: positive results at Screening for serology markers for hepatitis A, B, C and E (HA, HB, HC, and HE) indicating acute or chronic infection
- •* Patients at risk of developing or having reactivation of syphilis or tuberculosis
研究者
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