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This was a US-based, observational cross-sectional study with primary data collection via questionnaires directly administered to patients with MS receiving KESIMPTA and care partners of patients with MS (formal or informal)receiving KESIMPTA.
The study aimed to enroll ninety-four (94) patients/care partners. The time period for enrollment was dependent on the uptake of KESIMPTA in the real-world.
Data collected for the study was obtained directly from the patient/care partner within the web-based database: De-identified data was stored on a secure server and transferred for analysis. Responses from the patient and care partner surveys were pooled for analysis of study endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kesimpta | Patients or caregivers of patients administered Kesimpta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kesimpta | Other | There was no treatment allocation. Patients administered Kesimpta by prescription that started before inclusion of the patient into the study were enrolled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready | Proportion of respondents (patients and care partners) in top two rating categories (satisfied and extremely satisfied) for device satisfaction on use of KESIMPTA Sensoready® | Up to 6 months, at the time of survey completion |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients by US region of residence | Census US geographic region of residence (Northeast, Midwest, South, or West) | Up to 6 months, at the time of survey completion |
| Proportion of patients by educational level |
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Patients with MS Inclusion Criteria:
Care Partner Inclusion Criteria:
Patients with MS Exclusion Criteria:
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To ensure a representative sample of patients with MS, the patient study population will include patients who are new to the use of injectable treatments for MS, as well as those with use of other injectable MS treatments prior to initiation of KESIMPTA using the Sensoready® pen.
Patients care partner (formal or informal) may also be eligible for study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | East Hanover | New Jersey | 07936 | United States |
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| Label | URL |
|---|---|
| Results for COMB157GUS13 that is getting linked from the Novartis Clinical Trials Website | View source |
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| 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 |
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| ID | Term |
|---|---|
| C527517 | ofatumumab |
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|
Proportion of patients by educational level was collected
| Up to 6 months, at the time of survey completion |
| Patients Determined Disease Steps (PDDS) | PDDS was used as a proxy to Expanded Disability Status Scale (EDSS). People were asked to choose one out of nine options that best describes how well they walk. 0 is "normal" and 8 is "bedridden." | Up to 6 months, at the time of survey completion |
| General Health | Participants were asked "How is your general health today?" and they had to choose one out of five options that best describes how well they feel from "Poor", "Fair" ,"Good", "Very Good" to "Excellent". | Up to 6 months, at the time of survey completion |
| Proportion of patients by Multiple Sclerosis Phenotype | Proportion of patients by Multiple Sclerosis Phenotype was collected:
| Up to 6 months, at the time of survey completion |
| Proportion of patients with co-morbidities | Proportion of patients with co-morbidities was collected | Up to 6 months, at the time of survey completion |
| Importance of healthcare provider (HCP) instructions for first injection | Participants were asked to rate their level of agreement with each statement related to their first Kesimpta injection. 1) I felt it was essential to have a healthcare provider instruct me on how to perform my first KESIMPTA injection using the Sensoready® pen, 2) I felt I needed to have a healthcare provider watch me administer my first KESIMPTA injection using the Sensoready® pen, and 3) I felt comfortable receiving instructions from my healthcare provider in the clinic on how to administer my first KESIMPTA injection using the Sensoready® pen and did not need my healthcare provider to be present to administer it at home. Participants were asked to choose five options toward each statement from "Strongly Disagree" to "Strongly Agree". | Up to 6 months, at the time of survey completion |
| Level of anxiety with injections, in general | Participants were asked "Using a scale of 0 to 10, 0 being Not at All Confident and 10 being Extremely Confident, how confident do you feel about your ability to administer KESIMPTA using the Sensoready® pen on your own?" | Up to 6 months, at the time of survey completion |
| Proportion of patients performing preparation activities for injection | Proportion of patients performing preparation activities for injection:
| Up to 6 months, at the time of survey completion |
| Proportion of participants by site of administration | Proportion of participants by site of administration was collected:
| Up to 6 months, at the time of survey completion |
| Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT) | Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT) was collected among DMT experienced patients | Up to 6 months, at the time of survey completion |
| Proportion of patients who are DMT naïve or experienced | Proportion pf patients who are DMT naïve or experienced was collected. | Up to 6 months, at the time of survey completion |
| Proportion of participants by reasons for starting KESIMPTA | Proportion of participants by reasons for starting KESIMPTA was collected:
| Up to 6 months, at the time of survey completion |
| Proportion of participants by reasons to switch from most recent therapy | Proportion of participants by reasons to switch from most recent therapy (insurance, lack of efficacy/wear off effect, side-effects and tolerability, adherence concerns etc.) was collected among DMT experienced patients. | Up to 6 months, at the time of survey completion |
| Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration | Percentage of patients who agree with each attribute of the device Usability Characteristics during self-administration, based on patient self-report was collected:
| Up to 6 months, at the time of survey completion |
| Patient Confidence | Percentage o patients who agree with each attribute regarding confidence, based on patient self-report, was collected:
| Up to 6 months, at the time of survey completion |
| Overall device satisfaction by treatment duration | Overall device satisfaction. Participants choose between five options from 1: Extremely Dissatisfied, 2 Dissatisfied, 3: Neither Satisfied nor Dissatisfied, 4: Satisfied, 5: Extremely Satisfied. The higher score means a better overall devise satisfaction. | Up to 6 months, at the time of survey completion |
| Overall device satisfaction score of the study participants by DMT experience | Percentage of patients by overall satisfaction score (extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, extremely satisfied) by DMT experience | Up to 6 months, at the time of survey completion |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |