SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study ("SWABIMS Follow Up-study")
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Proportion of patients with new lesions on T2-weighted images after 12 months of treatment
研究概览
简要总结
The "SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study" is the follow up study of the "SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS)" (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes patients that finish the SWABIMS study for another 12 month with ongoing unchanged medication.
详细描述
Background
Multiple sclerosis is a chronic inflammatory 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 may 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
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 for 12 month after completing the SWABIMS study.
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 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful completion of the SWABIMS study
- •Written informed consent
- •Exclusion Criteria
- •Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
- •Secondary progressive MS
- •Uncontrolled severe medical disorder
- •Participation in any other studies
排除标准
- 未提供
研究组 & 干预措施
1
Interferon beta-1b 250ug subcutaneously every other day
干预措施: Interferon beta-1b group (Drug)
2
Interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)
干预措施: Interferon beta-1b/Atorvastatin group (Drug)
结局指标
主要结局
Proportion of patients with new lesions on T2-weighted images after 12 months of treatment
时间窗: Month 12
次要结局
- Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment.(Month 12)
- Cortical atrophy (changes in brain volume, changes in grey matter and white matter) on magnetic resonance imaging (MRI) after 12 months of treatment(Month 0)
- Gd-enhancing lesions on T1-weighted images after 12 months of treatment.(Month 12)
- Clinical disease progression (Expanded Disability Status Scale [EDSS], Multiple Sclerosis Functional Composite [MSFC] )(Month 0)
- Time to first relapse(Month 0)
- Time of first relapse(Month 12)
- Number of relapse-free patients after 12 months of treatment(Month 12)
- Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] )(Month 12)
- Relapse rate after 12 months of treatment(Month 12)
- Cortical atrophy (changes in brain volume, changes in grey matter and white matter) on magnetic resonance imaging (MRI)after 12 months of treatment(Month 12)
- Clinical disease progression (Expanded Disability Status Scale [EDSS] , Multiple Sclerosis Functional Composite [MSFC] )(Month 12)