CompletedNot Applicable

Characterizing the Use of Ofatumumab in a Real World Setting

Australia103 participantsStarted 2022-12-08

Plain-language summary

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.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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\].

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part I and II: Proportion of doses not completed within three days of the expected date

Timeframe: Initiation

Part I and II: Proportion of doses not completed within 3 days of the expected date

Timeframe: First 3 months of maintenance

Trial details

NCT IDNCT05090033

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02-06

View on ClinicalTrials.gov More Relapsing Multiple Sclerosis trials