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

Novartis

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Other: Ofatumumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05285904

COMB157GCH01

Details and patient eligibility

About

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.

Full 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 in a real-world setting in Switzerland over an observational period of 12 month.

Enrollment: 107 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

107 participants in 1 patient group

Ofatumumab

Description:

Population under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis

Treatment:

Other: Ofatumumab