Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Proportion of patients with new T2 lesions on MRI.
研究概览
简要总结
Title: Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with relapsing-remitting multiple sclerosis treated with interferon-beta-1b SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis
Short title: "SWABIMS"
Study phase: Phase IIb study
Study design: Multi-center, randomized, rater-blinded, parallel-group-study in Switzerland
Investigational product: Atorvastatin 40mg every day (oral) plus Interferon-beta
Reference product: Interferon-beta-1b 250mg given
Indication: Relapsing-remitting multiple sclerosis (RR-MS)
Study objectives: Comparison of efficacy, safety and tolerability of combination of Atorvastatin 40mg (per os) daily and Interferon-beta-1b e.o.d in patients with relapsing-remitting multiple sclerosis compared to monotherapy with Interferon-beta-1b e.o.d.
Primary Endpoint: Proportion of patients with new T2 lesions after 15 months of treatment.
详细描述
Background
Multiple sclerosis is considered to be a chronic inflammatory demyelinating autoimmune disease of the central nervous system. Statins are lipid-lowering drugs which inhibit the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA-) reductase, which is the main regulatory enzyme of cholesterol biosynthesis. In recent years many studies have demonstrated, that statins have anti-inflammatory and immunomodulatory properties in addition to their lipid-lowering effects. Therefore, statins seem to have therapeutic potential in immune-mediated disorders such as multiple sclerosis. Studies in experimental allergic encephalomyelitis (EAE), the animal model for the human demyelinating disease multiple sclerosis, as well as smaller studies in patients with relapsing-remitting multiple sclerosis showed beneficial effect on the course of the disease. But there are also reports of negative impact of statins on multiple sclerosis. Therefore, bigger studies are needed to investigate the therapeutical potential of statins in multiple sclerosis.
Objective
The objectives of this study are to assess the efficacy, safety and tolerability of the combination of Atorvastatin 40mg p.o. daily and Interferon-beta-1b sc e.o.d compared to monotherapy with Interferon-beta-1b sc e.o.d in patients with relapsing-remitting multiple sclerosis.
Methods
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsing-remitting forms of multiple sclerosis (according to McDonald's criteria)
- •At least 1 relapse in the past two year
- •> 3 Lesions on spinal or brain-MRI
- •EDSS score between 0 and 3.5, inclusive
- •Age between 18 and 55 years
- •Written informed consent
- •Negative pregnancy test results (all women)
- •Exclusion Criteria
- •Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
- •Primary progressive MS
- •Secondary progressive MS
- •Uncontrolled severe medical disorder
- •A history of drug abuse in the 6 months prior to screening
- •Previous therapy with Monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (except steroids)
- •Participation in any other studies
排除标准
- 未提供
研究组 & 干预措施
1
Interferon beta-1b AND atorvastatin
干预措施: Interferon beta 1b (Drug)
1
Interferon beta-1b AND atorvastatin
干预措施: Atorvastatin (Drug)
2
Interferon beta-1b
干预措施: Interferon beta 1b (Drug)
结局指标
主要结局
Proportion of patients with new T2 lesions on MRI.
时间窗: 15 months
次要结局
- Cortical atrophy(15 months)
- Gd-enhancing lesion on T1-weighted images(15 months)
- Clinical disease progression(15 months)
- Time to first relapse(15 months)