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This non-interventional study aims to observe the effect of early versus late Ofatumumab treatment in RMS patients in a real-world setting in Austria over an observational period of 24 months.
This multi-center, observational study will describe the effects of Ofatumumab in 2 cohorts in a routine medical care setting. Cohort one will comprise patients who have started Ofatumumab early during their disease (treatment naive patients or those that started Ofatumumab within 3 years of first therapy initiation). Cohort two will include patients who have been on other DMTs (one or several) for a minimum of 3 years prior to switching to Ofatumumab. Patients in both cohorts will be observed for two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Treatment Cohort (Cohort 1) | Patients that, before initiation of Ofatumumab, were either treatment naive or have started their treatment for RMS with another disease modifying therapy (BRACE, teriflunomide or fumarates). Non-naive patients in this cohort must have started the use of Ofatumumab within 3 years after first DMT initiation. |
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| Later Treatment Cohort (Cohort 2) | Patients that have been on BRACE and/or Teriflunomide and/or fumarates for at least three years or longer before the switch to Ofatumumab has been initiated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Other | There is no treatment allocation. For both cohorts, only patients that have received Ofatumumab treatment for at least 3 months prior to inclusion in the study will be enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients demonstrating NEDA-3 | Proportion and comparison of patients in both cohorts achieving NEDA-3 in the second year after treatment initiation, which refers to a comparison between month 12 and 24 after Ofatumumab treatment was initiated. NEDA-3 is defined by no confirmed MS relapse, no new or enlarging T2 lesions, no new Gadolinium-positive T1 lesions (in case Gadolinium was utilized), and no six-month confirmed disability worsening. | from month 12 up to month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients displaying NEDA-3, as well as individual NEDA components | Proportion of patients displaying NEDA-3, as well as individual NEDA components (i) experiencing no confirmed clinical relapses, (ii) lack of diseases progression measured by expanded disability status scale (EDSS) and (iii) absence of new disease activity (new or enhancing T2 or Gadolinium-positive T1 lesions (in case Gadolinium was utilized)), respectively, in the first treatment year (Baseline to month 12), the second treatment year (month 12 to month 24) as well as over the whole study period (Baseline to month 24). |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and treated for at least 3 months with Ofatumumab
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| C527517 | ofatumumab |
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| Baseline, month 12, month 24 |
| Proportion of patients permanently discontinuing Ofatumumab during the study | Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation will be provided | Up to 24 months |