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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab | Population under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with no evidence of disease activity (NEDA-3) | 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. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients demonstrating NEDA-3 | Proportion of patients demonstrating NEDA-3 and its components in relation to the Ofatumumab arm of STHENOS. | Month 12 |
| Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Baden | Canton of Aargau | 5405 | Switzerland | ||
| Novartis Investigative Site |
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Blood samples
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3:
|
| Month 12 |
| Proportion of patients with previous DMT medication | Proportion of patients with previous Disease-modifying Therapy (DMT) medication will be collected | Baseline |
| Proportion of patients with clinical and MRI parameters | 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) | Baseline |
| Proportion of Ofatumumab doses not completed | Proportion of Ofatumumab doses not completed and reason for not completion within 14 days of expected date. | Month 12 |
| Proportion of participants with a cumulative treatment interruption of more than six months | Proportion of participants with a cumulative treatment interruption of more than six months, calculated as 6 doses not completed. | Month 12 |
| Adherence to Ofatumumab | Proportion of participants with and without 100% adherence, defined as no dose administered outside of 14 days of expected date | Month 12 |
| Proportion of patients permanently discontinuing Ofatumumab | Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation. | Month 12 |
| Interdependency of adherence and clinical outcome in terms of NEDA-3 | Correlation between adherence and clinical outcome in terms of NEDA-3 activity to be measured | Month 12 |
| Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29 | 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 | Month 12 |
| Treatment satisfaction with Ofatumumab as measured by TSQM-9 | 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. | Month 12 |
| Lucerne |
| Canton of Lucerne |
| 6004 |
| Switzerland |
| Novartis Investigative Site | Lucerne | Canton of Lucerne | 6006 | Switzerland |
| Novartis Investigative Site | Sargans | Canton of St. Gallen | 7320 | Switzerland |
| Novartis Investigative Site | Gland | Canton of Vaud | 1196 | Switzerland |
| Novartis Investigative Site | Zurich | Canton of Zurich | 8006 | Switzerland |
| Novartis Investigative Site | Zurich | CHE | 8001 | Switzerland |
| Novartis Investigative Site | Basel | 4001 | Switzerland |
| Novartis Investigative Site | Bern | 3010 | Switzerland |
| Novartis Investigative Site | Lausanne | 1011 | Switzerland |
| Novartis Investigative Site | Lucerne | 6000 | Switzerland |
| Novartis Investigative Site | Lugano | 6900 | Switzerland |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C527517 | ofatumumab |
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