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

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

ClinicalTrials.gov Identifier: NCT05285904

Novartis Reference Number: COMB157GCH01

Last Update: Nov 16, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Condition

Multiple Sclerosis

Phase

Not Given

Overall status

Recruiting

Start date

May 12, 2022

Completion date

Dec 31, 2026

Gender

All

Age(s)

18 Years - 99 Years (Adult, Older Adult)

Interventions

Other

Ofatumumab

Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab, that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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