NCT01125475已完成不适用
A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects: the ScanSmart Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Adherence assessment
研究概览
简要总结
The primary objective is to determine adherence to Rebif® New Formulation administered by RebiSmart during 12 weeks of therapy in patients with RRMS.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18 and 65 years of age
- •Have relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald Criteria (2005)
- •Having an expanded disability status scale (EDSS) of less than 6 at the screening visit or within 2 months prior to the screening visit
- •Stable treatment (defined as treatment after titration period) with RebiSmart administered Rebif new formulation (RNF) 22/44 mcg subcutaneously thrice a week for a minimum of 4 weeks prior to inclusion
- •Previously treated with disease modifying drugs (DMDs) for a minimum of 6 months prior to the screening visit
- •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
- •Using a highly effective method of contraception for the duration of the study. This is defined as a method that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly , and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomized partner
- •Have a scheduled visit 12 weeks after the inclusion visit
- •Willing and able to comply with the protocol for the duration of the study
- •Have given written informed consent
排除标准
- •Have had a relapse within 30 days prior to the first visit
- •Have any contra-indications to treatment with Interferon-beta 1a according to Summary of Product Characteristics
- •Have any other significant disease that in the Investigator's opinion would exclude the subject from the trial
结局指标
主要结局
Adherence assessment
时间窗: 12 weeks
Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS
次要结局
未报告次要终点
研究者
研究点 (1)
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