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: Jun 14, 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.
Interventions
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
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]