Clinical trial NCT05285904: Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study
Official title: Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: NIS
Multiple sclerosis
MS
KOSMOS
Ofatumumab
Kesimpta
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and treated for at least 3 months with Ofatumumab

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with no evidence of disease activity (NEDA-3)
timeFrame: Month 12
Secondary outcomes:
measure: Proportion of patients demonstrating NEDA-3
timeFrame: Month 12
measure: Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3
timeFrame: Month 12
measure: Proportion of patients with previous DMT medication
timeFrame: Baseline
measure: Proportion of patients with clinical and MRI parameters
timeFrame: Baseline
measure: Proportion of Ofatumumab doses not completed
timeFrame: Month 12
measure: Proportion of participants with a cumulative treatment interruption of more than six months
timeFrame: Month 12
measure: Adherence to Ofatumumab
timeFrame: Month 12
measure: Proportion of patients permanently discontinuing Ofatumumab
timeFrame: Month 12
measure: Interdependency of adherence and clinical outcome in terms of NEDA-3
timeFrame: Month 12
measure: Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29
timeFrame: Month 12
measure: Treatment satisfaction with Ofatumumab as measured by TSQM-9
timeFrame: Month 12
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Novartis Investigative Site
state: Aargau
city: Liestal
country: Switzerland
facility: Novartis Investigative Site
state: BL
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
state: CHE
city: Chur
country: Switzerland
facility: Novartis Investigative Site
state: GR
city: Luzern
country: Switzerland
facility: Novartis Investigative Site
state: LU
city: Sargans
country: Switzerland
facility: Novartis Investigative Site
state: Saint Gallen
city: Wil
country: Switzerland
facility: Novartis Investigative Site
state: SG
city: Gland
country: Switzerland
facility: Novartis Investigative Site
state: Vaud
city: Zug
country: Switzerland
facility: Novartis Investigative Site
state: ZG
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
state: ZH
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Lugano
country: Switzerland
facility: Novartis Investigative Site
city: Luzern
country: Switzerland
facility: Novartis Investigative Site
city: Luzern
country: Switzerland
facility: Novartis Investigative Site
city: Sion
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: