NCT02598167已完成不适用
Assessing Patients Preferences Towards Disease-modifying Therapeutic Options in Relapsing Remitting Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 18
- 主要终点
- Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)
研究概览
简要总结
This multi-center non-interventional, observational, cross-sectional study in adult participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the participants' preferences for disease modifying treatments (DMT) in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged greater than or equal to (>/=) 18 years
- •Participants who have a diagnosis of RRMS as documented in their medical records
- •Participants who have been prescribed a DMT for at least 3 months
- •Participants who have an expanded disability status scale (EDSS) score of 1-6 points
排除标准
- •Participants with any personal or medical condition that in opinion of the investigator would interfere with or make impossible proper participation in the study
结局指标
主要结局
Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)
时间窗: Up to 3 months
Percentage of Participants With DMT Administration Schedule Preferences
时间窗: Up to 3 months
Percentage of Participants With DMT Route of Administration Preferences
时间窗: Up to 3 months
DMT Efficacy Based on Annualized Relapse Rate
时间窗: Up to 3 months
次要结局
- Duration since Last Relapse of RRMS(Baseline)
- Participants Current DMT for RRMS(Baseline)
- Participants Education Level(Baseline)
- Number of Relapses of RRMS in Last 2 Years(Baseline)
- Participants Employment Status(Baseline)
- Number of Previous DMTs Taken Prior to Switch to Current DMT(Baseline)
- Expanded Disability Status Scale (EDSS) Score(Up to 3 months)
- Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale Score(Up to 3 months)
- Participant's Role in Decision Making measured by the Shared Decision Making Questionnaire 9-item version (SDM-Q-9) Score(Up to 3 months)
- Participants RRMS Disease Duration(Baseline)
- Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score(Up to 3 months)
研究者
研究点 (18)
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