Real World Study to Evaluate Patient and Care Partner Ratings on Early Experience of Injection and Device for KESIMPTA® (Ofatumumab) Indicated for Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready
研究概览
简要总结
This was a US-based, observational cross-sectional study with primary data collection via questionnaires directly administered to patients with MS receiving KESIMPTA and care partners of patients with MS (formal or informal)receiving KESIMPTA.
详细描述
The study aimed to enroll ninety-four (94) patients/care partners. The time period for enrollment was dependent on the uptake of KESIMPTA in the real-world.
Data collected for the study was obtained directly from the patient/care partner within the web-based database: De-identified data was stored on a secure server and transferred for analysis. Responses from the patient and care partner surveys were pooled for analysis of study endpoints.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged eighteen (18) years of age or over at the time of the survey
- •Prescribed KESIMPTA within the prior 12 months and currently self-administering treatment using the Sensoready® pen
- •MS diagnosis based on 2017 McDonald criteria
- •Care Partner Inclusion Criteria:
- •Adult aged eighteen (18) years of age or over
- •Formal or informal care partner of patient with MS prescribed KESIMPTA within the prior 12 months
- •Is currently administering KESIMPTA using the Sensoready® pen on their patient's behalf
- •Patients with MS
排除标准
- •Previously used injection as a part of inclusion in any ofatumumab (OMB) randomized clinical trial
- •Active Hepatitis B virus (HBV)
- •Cognitive impairment that would impact their ability to participate in a survey study
结局指标
主要结局
Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready
时间窗: Up to 6 months, at the time of survey completion
Proportion of respondents (patients and care partners) in top two rating categories (satisfied and extremely satisfied) for device satisfaction on use of KESIMPTA Sensoready®
次要结局
- Proportion of patients who are DMT naïve or experienced(Up to 6 months, at the time of survey completion)
- Overall device satisfaction by treatment duration(Up to 6 months, at the time of survey completion)
- Overall device satisfaction score of the study participants by DMT experience(Up to 6 months, at the time of survey completion)
- Patient Confidence(Up to 6 months, at the time of survey completion)
- Proportion of participants by site of administration(Up to 6 months, at the time of survey completion)
- Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT)(Up to 6 months, at the time of survey completion)
- Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration(Up to 6 months, at the time of survey completion)
- Proportion of patients by US region of residence(Up to 6 months, at the time of survey completion)
- Proportion of patients by educational level(Up to 6 months, at the time of survey completion)
- Patients Determined Disease Steps (PDDS)(Up to 6 months, at the time of survey completion)
- Proportion of patients by Multiple Sclerosis Phenotype(Up to 6 months, at the time of survey completion)
- Proportion of patients with co-morbidities(Up to 6 months, at the time of survey completion)
- Importance of healthcare provider (HCP) instructions for first injection(Up to 6 months, at the time of survey completion)
- Level of anxiety with injections, in general(Up to 6 months, at the time of survey completion)
- General Health(Up to 6 months, at the time of survey completion)
- Proportion of patients performing preparation activities for injection(Up to 6 months, at the time of survey completion)
- Proportion of participants by reasons for starting KESIMPTA(Up to 6 months, at the time of survey completion)
- Proportion of participants by reasons to switch from most recent therapy(Up to 6 months, at the time of survey completion)