Multiple Sclerosis
Conditions
Keywords
NIS, Multiple sclerosis, MS, KOSMOS, Ofatumumab, Kesimpta
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.
Interventions
OTHEROfatumumab
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.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Proportion of patients with previous DMT medication | Baseline | Proportion of patients with previous Disease-modifying Therapy (DMT) medication will be collected |
| 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) |
| 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. |
| 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. |
| 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 |
| Proportion of patients permanently discontinuing Ofatumumab | Month 12 | Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation. |
| 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 |
| 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 |
| 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. |
Countries
Switzerland
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed