Secondary Use of Data Study Characterizing Kesimpta (Ofatumumab) Onboarding and Utilization in RMS Patients Using MSGo, With a Non-interventional Primary Use of Data Sub-study Comparing Patient Reported Outcomes Relative to Clinical Outcomes (EAFToS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 7
- 主要终点
- Part I and II: Proportion of doses not completed within three days of the expected date
研究概览
简要总结
This is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes.
详细描述
This study will be run in two parts. Part I will operate as a Secondary Use of Data study and Part II will operate as a Non-Interventional primary use of data study.
Part I: This study is descriptive in nature without any key underlying hypothesis and will explore the onboarding and adherence of RMS patients in Australia to ofatumumab treatment. De-identified patient-level onboarding and adherence data will be primarily generated and managed through the MSGo platform which will function as a Patient Support Service.
Part II: This part of the study will operate as a non-interventional primary use of data study and will explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes. This part of the study will only be conducted at a selection of participating clinics. Patients in this part of the study will also have data collected as part of Part I of the study.
The data for the PROs will be collected through a mobile based application .
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse
- •Expanded Disability Status Scale (EDSS) of 5.5 or lower (aligned with the plannedKEP criteria). Patients accessing ofatumumab through the PBS would have to meet the finalised restriction criteria (to be confirmed).
- •Patients will provide consent to participate in Part I of the study through the MSGo experience program or patient support program onboarding process.
- •Patients will need to provide additional consent to participate in Part II sub-study.
排除标准
- •Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information].
研究组 & 干预措施
Part I study cohort
Retrospective data analysis of up to 1500 de-identified participants contributing onboarding and adherence data via the MSGo Kesimpta Patient App.
干预措施: ofatumumab (Other)
Part II study cohort
Up to 100 participants responding to PROs via the MSGo Patient App
干预措施: ofatumumab (Other)
结局指标
主要结局
Part I and II: Proportion of doses not completed within three days of the expected date
时间窗: Initiation
Proportion of doses not completed within three days of the expected date during initiation to be collected
Part I and II: Proportion of doses not completed within 3 days of the expected date
时间窗: First 3 months of maintenance
Proportion of doses not completed within 3 days of the expected date during the first three months of maintenance to be collected
次要结局
- Part I: Proportion of participants discontinued within three months of the intial dose(Up to 18 months)
- Part I: Proportion of participants discontinued within 12 months of the intial dose.(Up to 18 months)
- Part I: Proportion of doses not completed within three days of the expected date(initiation period plus 12 months of maintenance)
- Part I: Proportion of doses not completed within 14 days of the expected date(12 months of maintentance)
- Part I: Proportion of participants with a treatment interruption of more than six months during maintenance(Up to 18 months)
- Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups(12 months)
- Part II: Proportion of doses not completed within 14 days of the expected date(during 18 months of maintenance)
- Part II: proportion of participants discontinued within 18 months of the intial dose(within 18 months of the initial dose)
- Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire(Baseline,6 months, 12 months, 18 months)
- Part II: Change in generic health status as measured by the EQ5D(Baseline, 6 months, 12 months, 18 months)
- Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC).(Baseline, 6 months, 12 months, 18 months)
- Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4)(Day 28, 6 months, 12 months, 18 months)
- Part II: Change in Expanded Disability Status Scale (EDSS)(Baseline, 6 months, 12 months)
- Part II: Number of new or enlarging T2 lesions on MRI(Baseline, 6 months, 12 months)
- Part II: Annualized relapse rate(12 months)
- Part II: Number of T1 Gd-enhancing lesions per MRI scan(Baseline, 6 months, 12 months)
- Percentage brain volume change(12 months follow up)
- Part II: Proportion of self administration(18 months)
- Part II: Proportion of patients initiating ofatumumab who are treatment naïve(Baseline)