Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 84
- 主要终点
- Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain
研究概览
简要总结
This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
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
- Double (Participant, Investigator)
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
- •Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- •Relapsing-remitting multiple sclerosis (MS)
- •Ages 18-55 years inclusive
- •For sexually active female and male participants of reproductive potential, use of reliable means of contraception
排除标准
- •Secondary or primary progressive multiple sclerosis at screening
- •Incompatibility with MRI
- •Contra-indications to or intolerance of oral or IV corticosteroids
- •Known presence of other neurologic disorders
- •Pregnancy or lactation
- •Lack of peripheral venous access
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal
- •Congestive heart failure
- •Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
- •History or known presence of recurrent or chronic infection
- •History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)
- •History of alcohol or drug abuse within 24 weeks prior to randomization
- •History of or currently active primary or secondary immunodeficiency
- •History of coagulation disorders
- •Treatment with any investigational agent within 4 weeks of screening
- •Receipt of a live vaccine within 6 weeks prior to randomization
- •Incompatibility with Avonex use
- •Previous treatment with rituximab
- •Previous treatment with lymphocyte-depleting therapies except mitoxantrone
- •Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization
- •Treatment with beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
- •Systemic corticosteroid therapy within 4 weeks prior to randomization
研究组 & 干预措施
Placebo
Participants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
干预措施: Placebo (Drug)
Ocrelizumab 600 mg
Participants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
干预措施: Ocrelizumab (Drug)
Ocrelizumab 1000 mg
Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
干预措施: Ocrelizumab (Drug)
Avonex
Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
干预措施: Avonex (Drug)
结局指标
主要结局
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain
时间窗: Week 12 to Week 24
Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.
次要结局
- Annualized Protocol Defined Relapse Rate at Week 24(Week 24)
- Percentage of Participants Who Remained Relapse Free at Week 24(Week 24)
- Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24(Baseline, Week 24)
- Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain(Weeks 4 to Week 24)
- Total Number of Gadolinium-Enhancing T1 Lesions(Weeks 4 to Week 24)