A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16
研究概览
简要总结
General Note: throughout this record, "Rebif® New Formulation" is used for historical and consistency purposes.
Objectives:
Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a [IFN-beta-1a], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo.
Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).
Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Males and females between 18 and 60 years of age
- •Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study
- •Have Relapsing Remitting Multiple Sclerosis (RRMS) according to the revised McDonald criteria 2005
- •Have brain and/or spinal MRI with findings typical of Multiple Sclerosis (MS)
- •Have disease duration for more than 12 months
- •Have disease activity characterized by at least one clinical event and one or more Gadolinium-enhancing MRI lesions within the 6 months prior to randomization
- •Have score of <=5.5 on the Expanded Disability Status Scale (EDSS)
- •Be willing and able to comply with the protocol for the duration of the study
- •Have given written informed consent prior to any study-related procedure not part of the normal medical practice
排除标准
- •Have any disease other than MS that could better explain his/her signs and symptoms
- •Have complete transverse myelitis or bilateral optic neuritis
- •Have received or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [ACTH]), or total lymphoid irradiation
- •Have received within 3 months prior to baseline any approved disease-modifying therapy for MS, cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, any investigational drug, or experimental procedure
- •Have received within 30 days prior to baseline oral or systemic corticosteroids or ACTH
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Rebif® New Formulation (IFN-beta-1a, RNF)
干预措施: Rebif® New Formulation (IFN-beta-1a, RNF) (Drug)
Placebo/RNF
干预措施: Placebo (Drug)
Placebo/RNF
干预措施: Rebif® New Formulation (IFN-beta-1a, RNF) (Drug)
结局指标
主要结局
Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16
时间窗: 16 Weeks
CU active lesions were defined as a unique newly active or persistently active lesion on the protocol density/time constant 2 (PD/T2) scan or the gadolinium (Gd-) enhanced time constant 1 (T1) scan (with a method to avoid double counting).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to Week 40
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AEs were categorized based upon the treatment period during which they occurred, that is, double-blind period (up to Week 16) and rater-blind period (Week 17 up to Week 40).
次要结局
- Mean Number of CU Lesions Per Scan Between the Initial 16 Weeks of Placebo Treatment and 24 Weeks of RNF Treatment in the Same Participants, Originally Randomized to Placebo.(Day 1 up to Week 16 and Week 17 up to Week 40)
- Number of CU Active MRI Lesions(Up to Week 40)