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 .
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.
Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information].
Full details can be found here
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