Characterizing the Use of Ofatumumab in a Real World Setting (EAFToS)

Novartis

Status: Active, not recruiting

Conditions: Relapsing Multiple Sclerosis

Treatments: Other: ofatumumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05090033

COMB157GAU01

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 103 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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].

Trial design

103 participants in 2 patient groups

Part I study cohort

Description:

Retrospective data analysis of up to 1500 de-identified participants contributing onboarding and adherence data via the MSGo Kesimpta Patient App.

Treatment:

Other: ofatumumab

Part II study cohort

Description:

Up to 100 participants responding to PROs via the MSGo Patient App

Treatment:

Other: ofatumumab