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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 821
- 试验地点
- 141
- 主要终点
- Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks
研究概览
简要总结
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
- •At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
- •Neurologic stability for greater than or equal to (>=) 30 days prior to both screening and baseline
- •Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
排除标准
- •Primary progressive multiple sclerosis
- •Disease duration of more than 10 years in participants with EDSS less than or equal to (<=) 2.0 at screening
- •Contraindications for MRI
- •Known presence of other neurological disorders which may mimic multiple sclerosis
- •Pregnancy or lactation
- •Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- •History of or currently active primary or secondary immunodeficiency
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •Active infection, or history of or known presence of recurrent or chronic infection (e.g., hepatitis B or C, human immunodeficiency virus [HIV], syphilis, tuberculosis)
- •History of progressive multifocal leukoencephalopathy
- •Contraindications to or intolerance of oral or iv corticosteroids
- •Contraindications to Rebif or incompatibility with Rebif use
研究组 & 干预措施
Interferon beta-1a 44 mcg SC
Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
干预措施: Interferon beta-1a (Drug)
Interferon beta-1a 44 mcg SC
Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
干预措施: Ocrelizumab-matching placebo (Drug)
Ocrelizumab
Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
干预措施: Ocrelizumab (Drug)
Ocrelizumab
Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
干预措施: Interferon beta-1a-matching placebo (Drug)
结局指标
主要结局
Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks
时间窗: Week 96
ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.
次要结局
- Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment(Baseline up to Week 96)
- Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment(Baseline up to Week 96)
- Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period(Week 108)
- Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks(Week 96)
- Number of T1 Hypointense Lesions During the Double-Blind Treatment(Baseline up to Week 96)
- Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96(Baseline, Week 96)
- Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96(From Week 24 up to Week 96)
- Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period(Week 108)
- Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96(Baseline, Week 96)
- Number of Participants With Adverse Events (AEs)(Baseline up to 588 weeks)
- Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)(Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96)
- Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96(Week 96)
- Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab(Baseline up to week 96)