NL-OMON43603已完成3 期
A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA 1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1
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 99（—）
入选标准
- •- adult patients, 18 - 55 years of age inclusive
- •- multiple sclerosis confirmed according to revised McDonald criteria (2010)
- •- relapsed-remitting or secondary progressive disease
- •- At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the year prior to screening (but not within 30 days prior to screening).
- •- Neurological stability for * 30 days prior to both screening and baseline
- •- EDSS, at screening, from 0 to 5.5 inclusive
- •Patients who meet the following entry criteria may participate in the OLE Phase:
- •-Complete the 96-week, double-blind, double-dummy treatment period, and who, in the opinion of the Investigator, may benefit from treatment with ocrelizumab;
- •-Are able and willing to provide written informed consent for the OLE Phase (e.g., before the first infusion at Cycle 5) and to comply with the study protocol;
- •-Are willing to continue to use at least two contraceptive methods;
- •-Meet re-treatment criteria with ocrelizumab (see Section 6.1.4).
排除标准
- •1. Diagnosis of primary progressive MS.
- •2. Disease duration of more than 10 years in patients with an EDSS * 2.0 at screening.
- •3. Inability to complete an MRI
- •4. Known presence of other neurological disorders which may mimic MS.
研究者
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