NCT06668324已完成不适用
Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation (MS-PEKOS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Proportion of patients reported local injection-related reaction post first injection
研究概览
简要总结
The study aims to compare the experiences, including injection-related reactions (IRRs) of patients newly receiving ofatumumab to those starting to receive ocrelizumab SC formulation
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to use a mobile device or computer with broadband internet access (or data streaming available)
- •Ability to read, understand, and respond in English
- •Adult aged 18 years of age or over at the time of the survey
- •Self-confirmed diagnosis of MS
- •Prescribed either OMB or OCR SC and will receive their first injection (Day 0) followed by completing the study survey between Day 1 and Day 7
排除标准
- •Participated in an OMB or OCR randomized clinical trial
- •Previously treated with OMB or OCR SC
- •Cognitive impairment that impacts the patient's ability to participate in a survey study
结局指标
主要结局
Proportion of patients reported local injection-related reaction post first injection
时间窗: Day 1- 7 post first injection, at the time of survey completion
Proportion of patients reported local injection-related reactions (including pain, erythema, induration, and pruritus) by using modified Defense and Veterans Pain Rating Scale (DVPRS)
次要结局
- Proportion of patients in a 5-Likert scale for satisfaction on injection-related experience (post first injection)(Day 1 - 7 post first injection, at the time of survey completion)
- Proportion of patients reported local injection-related reaction post second injection(Day 1- 7 post second injection, at the time of survey completion)
- Proportion of patients in a 5-Likert scale for satisfaction on injection-related experience (post second injection)(Day 1- 7 post second injection, at the time of survey completion)
研究者
研究点 (1)
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