Study Description
This is a multi-center, observational study carried out in Switzerland that aims to
describe the effects of Ofatumumab in a setting of routine medical care. This non-interventional study will observe the effect of Ofatumumab treatment compared to
the standard of care (SoC) arm of a closely monitored phase-IIIb study
(STHENOS-COMB157G3301) in MS patients in a real-world setting in Switzerland over an
observational period of 12 month.
Interventions
Ofatumumab
Eligibility Criteria
Inclusion Criteria:
1. Written informed consent must be obtained before participating in the study.
2. Diagnosis of RMS per McDonald Criteria (2017) occurred within 3 years prior to
initiation of Ofatumumab.
3. Adult patients who have been on treatment with Ofatumumab for at least 3 months, but
not longer than 12 months prior to inclusion in the study.
4. Ofatumumab treatment in line with the Swiss Kesimpta® label (i.e. adult patients
with active, relapsing forms of MS)
5. Patient is willing and able to complete patient diary during course of the study, as
well as to complete PRO questionnaires.
Exclusion Criteria:
1. Use of investigational drugs during the study, OR between Ofatumumab initiation and
inclusion into the study, OR within 3 months before Ofatumumab initiation, OR within
5 half-lives of investigational drug before Ofatumumab initiation, OR until the
expected pharmacodynamic effect has returned to baseline, whichever is longer.
2. Subjects who are not able to provide consent due to incapable judgement
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