A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis

Study Overview
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Brief Summary
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This is 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.

Detailed Description
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The study will aim to enroll ninety-four (94) patients/care partners. The time period for enrollment is dependent on the uptake of KESIMPTA in the real-world. Data collected for the study will be obtained directly from the patient/care partner within the web-based database: De-identified data will be stored on a secure server and transferred for analysis. Responses from the patient and care partner surveys will be pooled for analysis of study endpoints.

Official Title
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Real World Study to Evaluate Patient and Care Partner Ratings on Early Experience of Injection and Device for KESIMPTA® (Ofatumumab) Indicated for Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Kesimpta


Participation Criteria
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Eligibility Criteria
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Patients with MS Inclusion Criteria: Adult aged eighteen (18) years of age or over at the time of the survey Prescribed KESIMPTA within the prior 12 months and currently self-administering treatment using the Sensoready® pen MS diagnosis based on 2017 McDonald criteria Care Partner Inclusion Criteria: Adult aged eighteen (18) years of age or over Formal or informal care partner of patient with MS prescribed KESIMPTA within the prior 12 months Is currently administering KESIMPTA using the Sensoready® pen on their patient's behalf Patients with MS Exclusion Criteria: Previously used injection as a part of inclusion in any ofatumumab (OMB) randomized clinical trial Active Hepatitis B virus (HBV) Cognitive impairment that would impact their ability to participate in a survey study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kesimpta<br>Patients or caregivers of patients administered Kesimpta | Other: Kesimpta<br>* There is no treatment allocation. Patients administered Kesimpta by prescription that have started before inclusion of the patient into the study will be enrolled.<br>* Other names: ofatumumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Proportion of patients by educational level will be collected | Up to 6 months, at the time of survey completion | 
| Patients Determined Disease Steps (PDDS) | PDDS is used as a proxy to Expanded Disability Status Scale (EDSS). People are 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 QoL | Participants are asked How is your general health today? and they have 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 is collected: RRMS: Relapsing-Remitting Multiple Sclerosis SPMS: Secondary Progressive Multiple Sclerosis | Up to 6 months, at the time of survey completion | 
| Proportion of patients with co-morbidities | Proportion of patients with co-morbidities is collected | Up to 6 months, at the time of survey completion | 
| Importance of healthcare provider (HCP) instructions for first injection | Participants are 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 are asked to choose five options toward each statement from Strongly Disagree to Strongly Agree. | Up to 6 months, at the time of survey completion | 
| Proportion of participants with necessity of HCP at first injection | Proportion of participants with necessity of Health Care Professional (HCP) at first injection is collected | Up to 6 months, at the time of survey completion | 
| Level of anxiety with injections, in general | Participants are 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: talk to HCP/family/friends use of oral pain relief medications use of antihistamines prior to injection massage injection site apply ice/cold compress to injection site apply heat/hot compress to injection site apply numbing/pain relieving lotion/cream to injection site perform injection with assistance perform injection under medical supervision other strategies | Up to 6 months, at the time of survey completion | 
| Proportion of participants by site of administration | Proportion of participants by site of administration is collected: thigh abdomen upper outer arm | 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) is collected among DMT experienced patients | 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.) is collected among DMT experienced patients. | Up to 6 months, at the time of survey completion | 
| Proportion of patients who are injection naïve or experienced | Proportion pf patients who are injection naïve or experienced (autoinjector or prefilled syringe) is 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 is collected: ease of dosing schedule avoidance of infusion clinics at home convenience enhanced efficacy and safety profile HCP recommendation lack of insurance coverage for other DMTs Other | 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 is collected: Overall ease of use Device ergonomics (feeling in the hand ) Steps for preparing and using device Time required for preparation and use of device Convenience/Flexibility for travel with device | 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, is collected: Confidence to self-administer KESIMPTA using the device Intention to continue use of device Recommendation of KESIMPTA device use to others Ease of KESIMPTA's monthly dosing schedule | Up to 6 months, at the time of survey completion | 
| Overall device satisfaction based on patient self-report and care partner report | Overall device satisfaction based on patient self-report and care partner report is presented. 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 | 
| Injection experience based on patient self-report or care partner report | Injection experience based on patient self-report or care partner report is collected. Participants are asked to respond the following statements choosing between five options from 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree, 5: Strongly Agree. The higher score means a better outcome with injection experience. I can use KESIMPTA Sensoready® pen without any interference to my daily routine activities (work, social, or leisure activities) The amount of time required to prepare the KESIMPTA Sensoready® pen for use was reasonable | Up to 6 months, at the time of survey completion | 
| Time for injection in minutes | Time for injection in minutes, based on patient self-report or care partner report is collected: Time taken for two steps (i.e. removing drug out of refrigerator and injection to disposing pen in sharps container) Total Time | Up to 6 months, at the time of survey completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, Multiple Sclerosis, NIS, KESIMPTA, ofatumumab