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Characterizing the Use of Ofatumumab in a Real World Setting

NCT ID: NCT05090033

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-08

Study Completion Date

2025-12-31

Brief Summary

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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

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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 .

Conditions

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Relapsing Multiple Sclerosis

Keywords

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ofatumumab NIS RMS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

ofatumumab

Intervention Type OTHER

There is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Part II study cohort

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

ofatumumab

Intervention Type OTHER

There is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Interventions

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ofatumumab

There is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Intervention Type OTHER

Eligibility Criteria

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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\].
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Concord, New South Wales, Australia

Site Status

Novartis Investigative Site

Southport, Queensland, Australia

Site Status

Novartis Investigative Site

Clayton, Victoria, Australia

Site Status

Novartis Investigative Site

Melbourne, Victoria, Australia

Site Status

Novartis Investigative Site

Nedlands, Western Australia, Australia

Site Status

Novartis Investigative Site

Heidelberg, , Australia

Site Status

Novartis Investigative Site

St Leonards, , Australia

Site Status

Countries

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Australia

Other Identifiers

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COMB157GAU01

Identifier Type: -

Identifier Source: org_study_id