Assessment of Adherence, Effectiveness & Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 912
- 试验地点
- 1
- 主要终点
- Adherence to treatment
研究概览
简要总结
RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy. Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may improve patient satisfaction and adherence to therapy. The objectives of this study are to evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge.
详细描述
This is an observational, international, multicenter study planned to be conducted in RMS subjects using the RebiSmart auto-injector at 300 sites in 15 countries across Europe. The participating countries are Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Lithuania, Portugal, Slovakia, Sweden, Switzerland, the Netherlands and the United Kingdom. Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose injected by RebiSmart for no more than 6 weeks and meeting the eligibility criteria will receive Rebif 22 or 44 mcg subcutaneously three time a week. The dose of Rebif will be titrated during the initial four weeks of treatment. The planned observational period per subject is 12 months. The study visits comprises of: Baseline or Day 1 (Visit 1), Month 6 (Visit 2), and Month 12 (Visit 3).
OBJECTIVES
Primary objective:
- To assess adherence to treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge
Secondary objectives:
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 female subjects between 18-65 years of age (only in Germany: Males and females between 12 - 65 years of age in order to follow national medical society guidelines)
- •Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either: a) Post-menopausal or surgically sterile, or b) 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 vasectomised partner
- •Subjects diagnosed with Relapsing MS according to the revised McDonald Criteria (2005)
- •MS-treatment naïve subjects or subjects treated with Rebif multi-dose injected by RebiSmart for no longer than 6 weeks prior to Baseline visit
- •Subjects that are able to self-inject with RebiSmart (in the opinion of the physician)
- •Subjects with Expanded Disability Status Scale (EDSS) score < 6 (inclusive) at Baseline
- •Signed informed consent (in countries where subject signature is not mandatory: subject must be given the patient information)
排除标准
- •Subjects experiencing a relapse within 30 days before Baseline
- •Subjects who have participated in other studies within 30 days before Baseline
- •Subjects who received any MS therapy within 6 months prior to study enrolment (e.g., other disease modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif multi-dose injected by RebiSmart
- •Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart
- •Pregnancy and breast-feeding
- •Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
- •Current or past (within the last 2 years) history of alcohol or drug abuse
- •Have any contra-indications to treatment with interferon beta-1a according to Summary of Product Characteristics
结局指标
主要结局
Adherence to treatment
时间窗: Baseline to 12 months of treatment
Proportion of expected number of injections completed during 12 months of treatment as captured by RebiSmart.
次要结局
- Effectiveness and convenience of treatment(Baseline to 12 months of treatment)
- Safety of treatment(Baseline to 12 months)