NCT02394782终止不适用
A Prospective, Observational, International, Multi-center Study to Measure the Relationship Between Relapse and Adherence in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With Rebismart®2.0 + MSdialog™, Assessing Quality of Life (ADHERQOL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of Relapse-free Subjects
研究概览
简要总结
This is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™.
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
- •Diagnosed with RRMS according to McDonald criteria 2010
- •Relapse free within 30 days before Baseline data collection
- •Treatment with Rebif for 6 months or more prior to informed consent
- •Already using RebiSmart®2.0 + MSdialog™ for patient reported outcome (PRO) assessments (at least once prior to informed consent)
- •Females of childbearing potential must be willing to use appropriate contraception for the duration of the study
- •EDSS score less than (<) 6
- •Written informed consent obtained prior to any protocol-required data collection
排除标准
- •Participation in other studies within 30 days before Baseline
- •Female who is pregnant or breast feeding
- •Significant psychiatric symptoms that, in the opinion of the Investigator, would impact subject ability to comply with treatment (as per standard clinical practice)
- •Any contraindication for Interferon (IFN) beta-1a therapy as per Summary of Product Characteristics (SPC)
- •Administration of any Multiple Sclerosis (MS) therapy, other than Rebif, within 6 months prior to informed consent
结局指标
主要结局
Percentage of Relapse-free Subjects
时间窗: Up to 24 months
Relapse is defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement.
次要结局
- Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™(Up to 24 months)
- Annualized Relapse Rate(Months 12 and 24)
研究者
研究点 (1)
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