NCT02861014已完成3 期
An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 681
- 试验地点
- 163
- 主要终点
- Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
研究概览
简要总结
The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
- •Have a length of disease duration, from first symptom, of less than (<) 10 years
- •Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
- •Suboptimal disease control while on a DMT
- •Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
- •For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
排除标准
- •Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
- •Inability to complete an Magnetic Resonance Imaging (MRI) procedure
- •Known presence of other neurological disorders
- •Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- •History or currently active primary or secondary immunodeficiency
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •History of opportunistic infections
- •History or known presence of recurrent or chronic infection
- •History of malignancy
- •Congestive heart failure
- •Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
研究组 & 干预措施
Ocrelizumab
Experimental
Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
干预措施: Ocrelizumab (Biological)
结局指标
主要结局
Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
时间窗: Week 96
A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse (PDR) * 24-week CDP based on increase in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
次要结局
- Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume(Weeks 48, 96)
- Absolute Change From Baseline in EDSS Category at Week 96(Up to Week 96)
- Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From(Baseline, Week 96)
- Adjusted Mean Percentage Change From Baseline in Brain Volume(Weeks 24, 48, 96)
- Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96(Weeks: 24, 48, 96)
- Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96(Week 96)
- Time to Onset of First New and/or Enlarging T2 Lesion(Baseline up to 96 Weeks)
- Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume(Weeks 48, 96)
- Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume(Weeks 48, 96)
- Adjusted Mean Percentage Change From Baseline in White Matter Volume(Weeks 48, 96)
- Percentage Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score(Baseline, Weeks 48, 96)
- Percentage Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score(Baseline, Weeks: 48, 96)
- Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)(Baseline, Weeks: 24, 48, 72, 96)
- Time to Onset of First Protocol-Defined Relapse(Baseline up to 96 Weeks)
- Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96(Weeks 24, 48, 96)
- Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume(Weeks 48, 96)
- Mean Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score(Baseline, Weeks: 48, 96)
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to to 96 weeks after the end of the Treatment Period)
- Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period(Baseline up to 24 weeks)
- Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period(Baseline up to 48 weeks)
- Time to First Protocol-Defined Event of Disease Activity(Baseline up to 96 Weeks)
- Annualized Protocol-defined Relapse Rate at Week 96(Week 96)
- Time to Onset of 24-week Confirmed Disability Progression(Baseline up to 96 Weeks)
- Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI(Baseline, Week 96)
- Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan(Weeks 24, 48, 96)
- Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score(Baseline, Weeks 48, 96)
研究者
研究点 (163)
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