Characterizing the Use of Ofatumumab in a Real World Setting

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

Last Update: Jan 23, 2023

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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.

Condition 
Relapsing Multiple Sclerosis
Phase 
Not Given
Overall status 
Recruiting
Start date 
Dec 08, 2022
Completion date 
Jun 30, 2025
Gender 
All
Age(s)
18 Years and older (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 Locations

Australia
Novartis Investigative Site
Recruiting
Box Hill, 3128
Victoria
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3004
Victoria
Australia
Novartis Investigative Site
Recruiting
Heidelberg, 3084
-
Australia

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]