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Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting.
Prospective real-world data on ofatumumab is still very limited. For this reason, the main aim of this study is to investigate the impact of ofatumumab in a population of Italian RRMS patients in routine clinical practice to evaluate if ofatumumab is able in these conditions to provide relevant clinical benefits that comprehensively encompass anti-inflammatory activity (relapses), disability accumulation, cognitive impairment, fatigue symptoms and quality of life.
This is an observational, multicenter, single-arm, prospective study. Prospective data will be collected on patients newly treated with ofatumumab over an observational period of 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab | Patients treated with Ofatumumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Drug | This is an observational study. There is no treatment allocation. The decision to initiate treatment with ofatumumab (Kesimpta®) will be based solely on clinical judgement and according to the SmPC and AIFA reimbursement criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized relapse rate (ARR) | Annualized relapse rate (ARR) after a maximum observation period of 12 months of ofatumumab treatment. ARR is the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test) | To evaluate absolute and relative frequencies of patients with an improvement in SDMT (Symbol Digit Modality Test). An improvement is defined as an increase in the score of 4 or more points from baseline. The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. Higher scores indicate better performance. |
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Inclusion Criteria:
Exclusion Criteria:
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300 RRMS patients newly treated with ofatumumab.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ancona | AN | 60126 | Italy | ||
| Novartis Investigative Site |
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Sample of whole blood to evaluate KREC, TREC and B and T cells subset. Sample of Serum to evaluate NfL.
|
| Baseline, month 6, month 12 |
| Fatigue Severity Scale [FSS] | Proportion of patients passing from "fatigued" (F) to "not fatigued" (NF), according to the Fatigue Severity Scale [FSS]. FSS is a 9-statement interview with a 7-point scale response per statement, with higher scores indicating more fatigue. Patients with a mean FSS score ≥ 4 are considered fatigued (F), while those with a mean FSS score < 4 not fatigued (NF). | Baseline, month 3, month 6 and month 12 |
| Quality of life parameters assessed by EQ-5D-3L | EQ-5D-3L is a descriptive questionnaire comprising five dimensions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels of severity: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level of each of the five dimensions. | Baseline, 12 months |
| Treatment satisfaction assessed by TSQM-9 | Treatment Satisfaction Questionnaire for Multiple Sclerosis (TSQM-9). The TSQM-9 is a validated tool, widely used, to measure treatment satisfaction that will be applied in the context of this study regarding Ofatumumab. The TSQM-9 uses nine of the 14 TSQM Version 1.4 items, not including five questions related to side effects of medication, and comprises three scales: the effectiveness scale, the convenience scale and the global scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. | Month 6, month 12 |
| Expanded Disability Status Scale (EDSS) | Proportion of patients with an improved, stable or worsened EDSS. For patients with a baseline EDSS of 0 to 1.5, no disability improvement was possible based on the protocol definition of an improvement; for patients with a baseline EDSS of ≥2 to 6 or ≥6.5 to 9.5, the criterion for disability improvement was a decrease in EDSS of ≤1 or ≤0.5, respectively For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of ≥1.5, for patients with a baseline EDSS of 1 to 5 or ≥5.5, the criterion for disability worsening was an increase in EDSS of ≥1 or ≥0.5, respectively. | Baseline, month 12 months |
| Variation of NfL in plasma | Variation of Neurofilaments (NfL) in plasma of the patients | Baseline, month 6 and month 12 |
| Adverse Events (AEs) | Exposure-adjusted proportion of patients with adverse events (AE) or serious adverse events (SAE) per 100 subject-years. | 12 months |
| Discontinuation rates due to AE and/or other reasons | Discontinuation rates due to AE and/or other reasons | 12 months |
| L’Aquila |
| AQ |
| 67100 |
| Italy |
| Novartis Investigative Site | Bari | BA | 70124 | Italy |
| Novartis Investigative Site | Bergamo | BG | 24127 | Italy |
| Novartis Investigative Site | Chieti | CH | 66100 | Italy |
| Novartis Investigative Site | Catania | CT | 95123 | Italy |
| Novartis Investigative Site | Catanzaro | CZ | 88100 | Italy |
| Novartis Investigative Site | Cona | FE | 44124 | Italy |
| Novartis Investigative Site | Foggia | FG | 71122 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Genova | GE | 16132 | Italy |
| Novartis Investigative Site | Pozzilli | IS | 86077 | Italy |
| Novartis Investigative Site | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Palermo | PA | 90127 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Ravenna | RA | 48100 | Italy |
| Novartis Investigative Site | Reggio Calabria | RC | 89124 | Italy |
| Novartis Investigative Site | Roma | RM | 00168 | Italy |
| Novartis Investigative Site | Roma | RM | 00189 | Italy |
| Novartis Investigative Site | Siena | SI | 53100 | Italy |
| Novartis Investigative Site | Sassari | SS | 07100 | Italy |
| Novartis Investigative Site | Trento | TN | 38122 | Italy |
| Novartis Investigative Site | Orbassano | TO | 10043 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Treviso | TV | 31100 | Italy |
| Novartis Investigative Site | Udine | UD | 33100 | Italy |
| Novartis Investigative Site | Gallarate | VA | 21013 | Italy |
| Novartis Investigative Site | Vicenza | VI | 36100 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Naples | 80138 | Italy |
| Novartis Investigative Site | Novara | 28100 | Italy |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| 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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