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NCT Number: NCT05334472

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

East Hanover, New Jersey, 07936, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kesimpta

Other

There was no treatment allocation. Patients administered Kesimpta by prescription that started before inclusion of the patient into the study were enrolled.

Other names: ofatumumab

Primary outcomes

  1. Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready

    Time frame: Up to 6 months, at the time of survey completion

    Proportion of respondents (patients and care partners) in top two rating categories (satisfied and extremely satisfied) for device satisfaction on use of KESIMPTA Sensoready®

Secondary outcomes

  1. Proportion of patients by US region of residence

    Time frame: Up to 6 months, at the time of survey completion

    Census US geographic region of residence (Northeast, Midwest, South, or West)

  2. Proportion of patients by educational level

    Time frame: Up to 6 months, at the time of survey completion

    Proportion of patients by educational level was collected

  3. Patients Determined Disease Steps (PDDS)

    Time frame: Up to 6 months, at the time of survey completion

    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."

  4. General Health

    Time frame: Up to 6 months, at the time of survey completion

    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".

  5. Proportion of patients by Multiple Sclerosis Phenotype

    Time frame: Up to 6 months, at the time of survey completion

    Proportion of patients by Multiple Sclerosis Phenotype was collected:

    • RRMS: Relapsing-Remitting Multiple Sclerosis
    • SPMS: Secondary Progressive Multiple Sclerosis

  6. Proportion of patients with co-morbidities

    Time frame: Up to 6 months, at the time of survey completion

    Proportion of patients with co-morbidities was collected

  7. Importance of healthcare provider (HCP) instructions for first injection

    Time frame: Up to 6 months, at the time of survey completion

    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".

  8. Level of anxiety with injections, in general

    Time frame: Up to 6 months, at the time of survey completion

    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?"

  9. Proportion of patients performing preparation activities for injection

    Time frame: Up to 6 months, at the time of survey completion

    Proportion of patients performing preparation activities for injection:

    • Time to take KESIMPTA Sensoready® pen out of the refrigerator and allow it to reach room temperature prior to injection (minutes) (step A)
    • Time to perform the injection including picking up the Sensoready® pen, injecting and disposing in the sharps container (minutes) (step B)

  10. Proportion of participants by site of administration

    Time frame: Up to 6 months, at the time of survey completion

    Proportion of participants by site of administration was collected:

    • thigh
    • abdomen
    • upper outer arm

  11. Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT)

    Time frame: Up to 6 months, at the time of survey completion

    Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT) was collected among DMT experienced patients

  12. Proportion of patients who are DMT naïve or experienced

    Time frame: Up to 6 months, at the time of survey completion

    Proportion pf patients who are DMT naïve or experienced was collected.

  13. Proportion of participants by reasons for starting KESIMPTA

    Time frame: Up to 6 months, at the time of survey completion

    Proportion of participants by reasons for starting KESIMPTA was 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

  14. Proportion of participants by reasons to switch from most recent therapy

    Time frame: Up to 6 months, at the time of survey completion

    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.

  15. Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration

    Time frame: Up to 6 months, at the time of survey completion

    Percentage of patients who agree with each attribute of the device Usability Characteristics during self-administration, based on patient self-report was 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

  16. Patient Confidence

    Time frame: Up to 6 months, at the time of survey completion

    Percentage o patients who agree with each attribute regarding confidence, based on patient self-report, was 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

  17. Overall device satisfaction by treatment duration

    Time frame: Up to 6 months, at the time of survey completion

    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.

  18. Overall device satisfaction score of the study participants by DMT experience

    Time frame: Up to 6 months, at the time of survey completion

    Percentage of patients by overall satisfaction score (extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, extremely satisfied) by DMT experience

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2022
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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