Status:
ACTIVE_NOT_RECRUITING
Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-99 years
Brief Summary
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.
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained before participating in the study.
- Diagnosis of RMS per McDonald Criteria (2017) occurred within 3 years prior to initiation of Ofatumumab.
- 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.
- Ofatumumab treatment in line with the Swiss Kesimpta® label (i.e. adult patients with active, relapsing forms of MS)
- Patient is willing and able to complete patient diary during course of the study, as well as to complete PRO questionnaires.
Exclusion
- 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.
- Subjects who are not able to provide consent due to incapable judgement
Key Trial Info
Start Date :
May 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT05285904
Start Date
May 12 2022
End Date
March 31 2026
Last Update
December 1 2025
Active Locations (13)
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1
Novartis Investigative Site
Baden, Canton of Aargau, Switzerland, 5405
2
Novartis Investigative Site
Lucerne, Canton of Lucerne, Switzerland, 6004
3
Novartis Investigative Site
Lucerne, Canton of Lucerne, Switzerland, 6006
4
Novartis Investigative Site
Sargans, Canton of St. Gallen, Switzerland, 7320