NCT05090033Completed
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)
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 103 (actual)
- First submitted
- 22 Sept 2021
- Start date
- 8 Dec 2022
- Primary completion date
- 6 Feb 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT05090033
What you commit to
- Study type: Observational
- Participants enrolled: 103
- From 8 Dec 2022 to the primary completion date, 6 Feb 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information\].
Who the study is looking for
- 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.
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Concord | Australia | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.