NCT00292266已完成3 期
An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 677
- 主要终点
- Percentage of exacerbation-free subjects
研究概览
简要总结
This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex® 30 mcg intramuscular injection given once a week.
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
- 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
- •Age between 18 and 55 years
- •Clinically definite or laboratory-supported definite relapsing-remitting MS according to Poser's criteria
- •Two or more relapses within the preceding 24 months
- •Clinical stability or improving neurological state during the 4 weeks before Study Day 1
- •Expanded disability status scale (EDSS) score from 0 to 5.5, inclusive
- •Two or more lesions consistent with MS on a Screening proton density/T2-magnetic resonance imaging (MRI) scan to be performed 28 plus/minus (+/-) 4 days before the Study Day 1 MRI
- •Willingness and ability to comply with the protocol for the duration of the study
- •Written informed consent given before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care
- •For female subjects, lack of childbearing potential must be satisfied by either being post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized)
排除标准
- •Secondary progressive MS, primary progressive MS or progressive relapsing MS
- •Prior use of interferon
- •Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks of Study Day 1 or within 7 days before the Screening MRI
- •Psychiatric disorder that is unstable or will preclude safe participation in the study
- •Significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of Study Day 1
- •Elevated liver function tests (Alanine transaminase [ALT], Aspartate transaminase [AST], alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal) within 7 days of Study Day 1
- •Prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months before Study Day 1
- •Immunomodulatory or immunosuppressive therapy within the 12 months before Study Day 1, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone
- •Previous use of cladribine or total lymphoid irradiation
- •Allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic acid (DTPA)
- •Intravenous immunoglobulin or any other investigational drug or procedure in the 6 months before Study Day 1
- •Systemic disease that can interfere with subject safety, compliance or evaluation of the condition under study, such as insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (HIV) or Human T-cell lymphotrophic virus, Type-1 (HTLV-1)
研究组 & 干预措施
Rebif®
Experimental
干预措施: Rebif® (Drug)
Avonex®
Active Comparator
干预措施: Avonex® (Drug)
结局指标
主要结局
Percentage of exacerbation-free subjects
时间窗: Week 72
次要结局
- Mean number of combined unique (CU) active lesions per subject per scan(Week 24)
- Total exacerbation count per subject(Week 24, 48 and 72)
- Mean Number of Time constant 2 (T2) active lesions per subject per scan(Week 24, 48 and 72)
研究者
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