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
Novartis Investigative Site
Recruiting
Baden,Aargau,5405,Switzerland
Novartis Investigative Site
Recruiting
Luzern,6004,Switzerland
Novartis Investigative Site
Recruiting
Zurich,ZH,8006,Switzerland
Novartis Investigative Site
Recruiting
Liestal,BL,4410,Switzerland
Novartis Investigative Site
Recruiting
Sion,1950,Switzerland
Novartis Investigative Site
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Basel,4001,Switzerland
Novartis Investigative Site
Recruiting
Zuerich,CHE,8001,Switzerland
Novartis Investigative Site
Recruiting
Zurich,8091,Switzerland
Novartis Investigative Site
Recruiting
Bern,3010,Switzerland
Novartis Investigative Site
Recruiting
Luzern,LU,6006,Switzerland
Novartis Investigative Site
Recruiting
Lausanne,1011,Switzerland
Novartis Investigative Site
Recruiting
Sargans,Saint Gallen,7320,Switzerland
Novartis Investigative Site
Recruiting
Lugano,6900,Switzerland
Novartis Investigative Site
Recruiting
Gland,Vaud,1196,Switzerland
Novartis Investigative Site
Recruiting
Luzern,6000,Switzerland
Novartis Investigative Site
Recruiting
Zug,ZG,6300,Switzerland
Worldwide Contacts
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