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Characterizing the Use of Ofatumumab in a Real World Setting

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Relapsing Multiple Sclerosis

Interventions: ofatumumab

Countries: Australia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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\].

Locations (7)

Concord, New South Wales, Australia
Southport, Queensland, Australia
Clayton, Victoria, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Heidelberg, Australia
St Leonards, Australia