New perSEPtion. New Patient's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based RRMS Treatments.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- Number of Participants who Perceived the Treatment Added Value of Natalizumab Assessed by Likert's Scale
研究概览
简要总结
The primary objective of the study is to understand what the added value of natalizumab (Tysabri®) treatment is from a participant's perspective at a given time, based on a one-shot survey. The secondary objectives of the study also aim to characterize the participant's decision-making process to get the treatment; the burden of treatment, characterization of the study population, assessment of the quality of life (QoL), and fatigue dimension.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 diagnosed with RRMS and followed by a neurologist in France.
排除标准
- •Lack of literacy
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Number of Participants who Perceived the Treatment Added Value of Natalizumab Assessed by Likert's Scale
时间窗: Day 1
A Likert scale is a rating scale used to measure opinions, attitudes, or behaviors. This 7-pointer scale consists of a statement or a question, followed by a series of five or seven answer statements. Respondents choose the option that best corresponds with how they feel about the statement or question. The options include: strongly agree, agree, somewhat agree, neutral, somewhat disagree, disagree to strongly disagree.
次要结局
- Number of Participants Characterized by MS Duration(Day 1)
- Number of Participants who Perceived Burden of Treatment Assessed by Closed and Open-ended Questions(Day 1)
- Number of Participants With Perceived Decision-making Process Assessed by Likert's Scale(Day 1)
- Number of Participants Characterized by Multiple Sclerosis (MS) Types(Day 1)
- Mean Fatigue Severity Scale (FSS) Score(Day 1)
- Number of Participants With Perceived Decision-making Process Assessed by Open-ended Questions on Quality of Life (QOL)(Day 1)
- Number of Participants Characterized by Current Disease Modifying Treatment (DMT)(Day 1)
- Mean Multiple Sclerosis International Quality of Life Questionnaire (MusiQol) Score(Day 1)