NCT01592474已完成不适用
Evolution of Gray Matter Atrophy Over 4 Years in Observational Study of Early IFNβ-1a I.M. Treatment in High Risk Subjects After Clinically Isolated Syndrome (SET Substudy)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Can Avonex delay development of clinically definite MS?
研究概览
简要总结
The purpose of this study is
- To examine if Avaonex can delay the development of clinically definite multiple sclerosis.
- To investigate if Avonex can delay disability progression by slowing brain atrophy.
详细描述
- Multiple sclerosis (MS) is a chronic inflammatory disorder characterized by focal areas of demyelination in the central nervous system (CNS). MRI findings suggest that we should look at gray matter atrophy as a marker of the disease process in MS.
- Avonex is a proven effective disease-modifying treatment, which reduces total brain and GM atrophy and should be considered first-line therapy in patients with RRMS and CIS.
- The original SET study is an open-label observational study of high risk subjects after CIS for development of CDMS that will enroll 220 patients who have started Avonex immediately after their first clinical attack in Czech Republic, and are followed with clinical and MRI examinations for 4 years at 0, 6, 12, 24, 36 and 48 months. The clinical and MRI acquisition examinations of this study are conducted in Czech Republic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •MRI findings must reveal at least 2 hyperintense lesions on T2-WI or FLAIR images at first clinical onset
- •CSF examination should confirm oligoclonal bands (examination must be done in an internationally approved lab and the CSF taken before the treatment of attack starts)
- •Age 18 - 55 years
- •Effective contraception in female patients of childbearing potential
- •Kurtzke EDSS ≤ 3.5 at baseline
- •Willingness to accept the plan of the study and compliance with the study
- •Time from the beginning of first symptoms of CIS to baseline visit should not exceed 4 months (baseline MRI and baseline visit will be organized first 28 days after last steroid administration)
- •CIS attack is treated by at least 3g of methylprednisolone without taper
- •In case of severe attack 1 g of cyclophosphamide does not disqualify the patient from the study if first MRI and CSF examination was done before treatment administered
- •No active major organ disease especially of hepatic or thyroid origin
排除标准
- •The clinical diagnosis of MS is definite (the second attack occurs before the baseline visit)
- •Age less than 18 or more than 55
- •Non-effective contraception method or pregnancy planning
- •Active major organ disease, especially hepatic or endocrinologic
- •Cooperation of the subject cannot be ensured
- •Kurtzke EDSS higher than 3.5 at baseline
结局指标
主要结局
Can Avonex delay development of clinically definite MS?
时间窗: 5
To examine whether Avonex can delay the development of clinically definite multiple sclerosis
次要结局
- Can Avonex delay disability progression?(5)
研究者
Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center, Professor
University at Buffalo
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