Last Update: Dec 06, 2023
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)
ClinicalTrials.gov Identifier:
NCT05090033
Novartis Reference Number:COMB157GAU01
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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 .

Relapsing Multiple Sclerosis
Recruiting
1500
Dec 08, 2022
Jun 30, 2025
All
18 Years - (Adult, Older Adult)

Interventions

Other

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.

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].

Study Location

Novartis Investigative Site

Recruiting

Concord,New South Wales,2139,Australia

Novartis Investigative Site

Recruiting

Heidelberg,3084,Australia

Novartis Investigative Site

Recruiting

Melbourne,Victoria,3004,Australia

Novartis Investigative Site

Recruiting

Nedlands,Western Australia,6009,Australia

Novartis Investigative Site

Recruiting

Southport,Queensland,4222,Australia

Novartis Investigative Site

Recruiting

Box Hill,Victoria,3128,Australia

Novartis Investigative Site

Recruiting

St Leonards,New South Wales,2065,Australia

Novartis Investigative Site

Recruiting

Clayton,Victoria,3168,Australia

Worldwide Contacts

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Novartis Pharmaceuticals

+41613241111