A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
研究概览
简要总结
This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, between the ages of 18 and 60 years
- •Subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)
- •Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) (according to the 2010 McDonald MS diagnostic criteria)
- •Other protocol defined inclusion criteria could apply
排除标准
- •Any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
- •Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI
- •Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
- •Contraindication to Copaxone use
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Plovamer acetate 0.5 milligram (mg)
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
干预措施: Plovamer acetate 0.5 milligram (mg) (Drug)
Plovamer acetate 3 mg
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
干预措施: Plovamer acetate 3 mg (Drug)
Plovamer acetate 10 mg
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
干预措施: Plovamer acetate 10 mg (Drug)
Plovamer acetate 20 mg
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
干预措施: Plovamer acetate 20 mg (Drug)
Copaxone 20 mg
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
干预措施: Copaxone 20 mg (Drug)
结局指标
主要结局
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
时间窗: Baseline , Week 12, 24, 28, 32, 36, 40
Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.
次要结局
- Percentage of Subjects Remaining Relapse-Free(Baseline up to Week 40)
- Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan(Weeks 12, 24, 28, 32, 36, 40)
- Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan(Baseline, Weeks 12, 24, 28, 32, 36, 40)
- Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan(Baseline, Weeks 12, 24, 28, 32, 36, 40)
- Time to First Relapse(Baseline up to Week 40)
- Mean Change From Baseline in Brain Volume Per Subject(Baseline, Weeks 24, 28, 32, 36, 40)
- Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan(Weeks 12, 24, 28, 32, 36,40)
- Mean Annualized Relapse Rate (ARR)(Baseline up to Week 40)
- Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan(Weeks 12, 24, 28, 32, 36, 40)