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

See if you pre-qualify

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

Study Locations

Switzerland
Novartis Investigative Site
Recruiting
Baden, 5405
Aargau
Switzerland
Novartis Investigative Site
Recruiting
Zuerich, 8001
CHE
Switzerland
Novartis Investigative Site
Recruiting
Chur, 7000
GR
Switzerland
Novartis Investigative Site
Recruiting
Luzern, 6006
LU
Switzerland
Novartis Investigative Site
Recruiting
Sargans, 7320
Saint Gallen
Switzerland
Novartis Investigative Site
Recruiting
Wil, 9500
SG
Switzerland
Novartis Investigative Site
Recruiting
Zug, 6300
ZG
Switzerland
Novartis Investigative Site
Recruiting
Zurich, 8006
ZH
Switzerland
Novartis Investigative Site
Recruiting
Basel, 4001
-
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1011
-
Switzerland
Novartis Investigative Site
Recruiting
Lugano, 6900
-
Switzerland
Novartis Investigative Site
Recruiting
Luzern, 6000
-
Switzerland
Novartis Investigative Site
Recruiting
Luzern, 6004
-
Switzerland

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]