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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05285904
• Collaborator: (none)
• Enrollment: 149
• Locations: 15
• Anticipated Duration (Months): 55.7
• Patients Per Site: 9.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Ofatumumab

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 149 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)
• Actual Study Start Date: May 12, 2022
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Ofatumumab Population under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis	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.

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with no evidence of disease activity (NEDA-3) [Month 12]

   No evidence of disease activity (NEDA-3), as defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening, as compared to the SoC arm of STHENOS.

Secondary Outcome Measures

1. Proportion of patients demonstrating NEDA-3 [Month 12]

   Proportion of patients demonstrating NEDA-3 and its components in relation to the Ofatumumab arm of STHENOS.

2. Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3 [Month 12]

   Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3: No confirmed MS relapse No new or enlarging T2 lesions No Gadolinium-positive T1 lesions No six-month confirmed disability worsening

3. Proportion of patients with previous DMT medication [Baseline]

   Proportion of patients with previous Disease-modifying Therapy (DMT) medication will be collected

4. Proportion of patients with clinical and MRI parameters [Baseline]

   Proportion of patients with Magnet Resonance Imaging (MRI) and clinical parameters will be collected. Clinical parameters includes number of T2-hyperintense lesions, T1-contrast-enhancing lesions; number of MS relapse; Extended disability status scale (EDSS)

5. Proportion of Ofatumumab doses not completed [Month 12]

   Proportion of Ofatumumab doses not completed and reason for not completion within 14 days of expected date.

6. Proportion of participants with a cumulative treatment interruption of more than six months [Month 12]

   Proportion of participants with a cumulative treatment interruption of more than six months, calculated as 6 doses not completed.

7. Adherence to Ofatumumab [Month 12]

   Proportion of participants with and without 100% adherence, defined as no dose administered outside of 14 days of expected date

8. Proportion of patients permanently discontinuing Ofatumumab [Month 12]

   Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation.

9. Interdependency of adherence and clinical outcome in terms of NEDA-3 [Month 12]

   Correlation between adherence and clinical outcome in terms of NEDA-3 activity to be measured

10. Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29 [Month 12]

    The Multiple Sclerosis Impact Scale (MSIS-29) Questionnaire is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options. Higher scores reflect greater impact on day to day life

11. Treatment satisfaction with Ofatumumab as measured by TSQM-9 [Month 12]

    The TSQM-9 is a patient questionnaire assessing treatment satisfaction with Ofatumumab. It consists of 3 subscales: effectiveness, convenience and global satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Baden	Aargau	Switzerland	5405
2	Novartis Investigative Site	Liestal	BL	Switzerland	4410
3	Novartis Investigative Site	Zuerich	CHE	Switzerland	8001
4	Novartis Investigative Site	Chur	GR	Switzerland	7000
5	Novartis Investigative Site	Luzern	LU	Switzerland	6006
6	Novartis Investigative Site	Sargans	Saint Gallen	Switzerland	7320
7	Novartis Investigative Site	Wil	SG	Switzerland	9500
8	Novartis Investigative Site	Zug	ZG	Switzerland	6300
9	Novartis Investigative Site	Zurich	ZH	Switzerland	8006
10	Novartis Investigative Site	Basel		Switzerland	4001
11	Novartis Investigative Site	Bern		Switzerland	3010
12	Novartis Investigative Site	Lausanne		Switzerland	1011
13	Novartis Investigative Site	Lugano		Switzerland	6900
14	Novartis Investigative Site	Luzern		Switzerland	6000
15	Novartis Investigative Site	Luzern		Switzerland	6004

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05285904
• Other Study ID Numbers: COMB157GCH01
• First Posted: Mar 18, 2022
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Novartis Pharmaceuticals: NIS; Multiple sclerosis; MS; KOSMOS; Ofatumumab; Kesimpta
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis; Ofatumumab

Study Results

No Results Posted as of Jul 12, 2022