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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 103
- Locations
- 7
- Primary Endpoint
- Part I and II: Proportion of doses not completed within three days of the expected date
Study Overview
Brief Summary
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.
Detailed Description
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 .
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information].
Arms & Interventions
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.
Intervention: ofatumumab (Other)
Part II study cohort
Up to 100 participants responding to PROs via the MSGo Patient App
Intervention: ofatumumab (Other)
Outcomes
Primary Outcomes
Part I and II: Proportion of doses not completed within three days of the expected date
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)