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Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Multiple Sclerosis

Interventions: Ofatumumab

Countries: Switzerland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (13)

Baden, Canton of Aargau, Switzerland
Lucerne, Canton of Lucerne, Switzerland
Lucerne, Canton of Lucerne, Switzerland
Sargans, Canton of St. Gallen, Switzerland
Gland, Canton of Vaud, Switzerland
Zurich, Canton of Zurich, Switzerland
Zurich, CHE, Switzerland
Basel, Switzerland
Bern, Switzerland
Lausanne, Switzerland
Lucerne, Switzerland
Lugano, Switzerland
Zurich, Switzerland