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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 681
- 试验地点
- 321
- 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
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 (321)
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