Study Description
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.
Interventions
Ofatumumab
Eligibility Criteria
Inclusion Criteria:
1. Patients with relapsing multiple sclerosis (RMS) with disease activity defined by
clinical assessment or MRI analysis.
2. Written informed consent must be obtained before participating in the study.
3. Patient is willing and able to complete the assessments, as outlined in this study.
4. Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of
Ofatumumab.
5. Patients in both cohorts must have been on treatment with Ofatumumab for at least 3
months, but not longer than 12 months prior to inclusion in the study.
6. 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.
7. Cohort 2: Patients must have been on either BRACE or Teriflunomide or fumarates for
at least three years or longer before the switch to Ofatumumab has been initiated.
Thus, this cohort includes patients that use Ofatumumab as second or later line DMT.
Exclusion Criteria:
1. Patients who have been on Ofatumumab less than 3 months or more than 12 months
before inclusion.
2. Use of investigational drugs during the study, OR between Ofatumumab initiation and
inclusion into the study, OR within 5 half-lives of investigational drug before
Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to
baseline, whichever is longer.
3. Use of any high efficacy therapy (including Fingolimod, Siponimod, Ponesimod,
Ozanimod, Rituximab, Ocrelizumab, Natalizumab, Alemtuzumab, Mitoxantron or
Cladribine) in either cohort prior to the initiation of Ofatumumab.
4. Previous use of any DMTs other than BRACE, Teriflunomide or fumarates prior to the
initiation of Ofatumumab.
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