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

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ClinicalTrials.gov Identifier: NCT05334472
Recruitment Status : Recruiting
First Posted : April 19, 2022
Last Update Posted : February 1, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date March 21, 2022
First Posted Date April 19, 2022
Last Update Posted Date February 1, 2023
Actual Study Start Date November 24, 2021
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2022)		 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®
Original Primary Outcome Measures
 (submitted: April 12, 2022)		 Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready [ Time Frame: Month 1 ]
Proportion of respondents (patients and care partners) in top two rating categories (satisfied and extremely satisfied) for device satisfaction on use of KESIMPTA Sensoready®
Change History
Current Secondary Outcome Measures
 (submitted: October 14, 2022)
  • 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)
  • Proportion of patients by educational level [ Time Frame: Up to 6 months, at the time of survey completion ]
    Proportion of patients by educational level will be collected
  • Patients Determined Disease Steps (PDDS) [ Time Frame: Up to 6 months, at the time of survey completion ]
    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."
  • General QoL [ Time Frame: Up to 6 months, at the time of survey completion ]
    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".
  • 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 is collected:
    • RRMS: Relapsing-Remitting Multiple Sclerosis
    • SPMS: Secondary Progressive Multiple Sclerosis
  • Proportion of patients with co-morbidities [ Time Frame: Up to 6 months, at the time of survey completion ]
    Proportion of patients with co-morbidities is collected
  • Importance of healthcare provider (HCP) instructions for first injection [ Time Frame: Up to 6 months, at the time of survey completion ]
    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".
  • Proportion of participants with necessity of HCP at first injection [ Time Frame: Up to 6 months, at the time of survey completion ]
    Proportion of participants with necessity of Health Care Professional (HCP) at first injection is collected
  • Level of anxiety with injections, in general [ Time Frame: Up to 6 months, at the time of survey completion ]
    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?"
  • 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:
    • 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
  • 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 is collected:
    • thigh
    • abdomen
    • upper outer arm
  • 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) is collected among DMT experienced patients
  • 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.) is collected among DMT experienced patients.
  • Proportion of patients who are injection naïve or experienced [ Time Frame: Up to 6 months, at the time of survey completion ]
    Proportion pf patients who are injection naïve or experienced (autoinjector or prefilled syringe) is collected.
  • 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 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
  • 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 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
  • 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, 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
  • Overall device satisfaction based on patient self-report and care partner report [ Time Frame: Up to 6 months, at the time of survey completion ]
    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.
  • Injection experience based on patient self-report or care partner report [ Time Frame: Up to 6 months, at the time of survey completion ]
    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
  • Time for injection in minutes [ Time Frame: Up to 6 months, at the time of survey completion ]
    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
Original Secondary Outcome Measures
 (submitted: April 12, 2022)
  • Proportion of patients by US region of residence [ Time Frame: Baseline ]
    Census US geographic region of residence (Northeast, Midwest, South, or West)
  • Proportion of patients by educational level [ Time Frame: Baseline ]
    Proportion of patients by educational level will be collected
  • Patients Determined Disease Steps (PDDS) [ Time Frame: Baseline, month 1, month 3 ]
    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."
  • General QoL [ Time Frame: Baseline, month 1, month 3 ]
    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".
  • Proportion of patients by Multiple Sclerosis Phenotype [ Time Frame: Baseline ]
    Proportion of patients by Multiple Sclerosis Phenotype is collected:
    • RRMS: Relapsing-Remitting Multiple Sclerosis
    • SPMS: Secondary Progressive Multiple Sclerosis
  • Proportion of patients with co-morbidities [ Time Frame: Baseline ]
    Proportion of patients with co-morbidities is collected
  • Importance of healthcare provider (HCP) instructions for first injection [ Time Frame: Baseline ]
    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".
  • Proportion of participants with necessity of HCP at first injection [ Time Frame: Baseline ]
    Proportion of participants with necessity of Health Care Professional (HCP) at first injection is collected
  • Level of anxiety with injections, in general [ Time Frame: Baseline ]
    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?"
  • Proportion of patients performing preparation activities for injection [ Time Frame: Baseline ]
    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
  • Proportion of participants by site of administration [ Time Frame: Baseline ]
    Proportion of participants by site of administration is collected:
    • thigh
    • abdomen
    • upper outer arm
  • Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT) [ Time Frame: Baseline ]
    Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT) is collected among DMT experienced patients
  • Proportion of participants by reasons to switch from most recent therapy [ Time Frame: Baseline ]
    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.
  • Proportion of patients who are injection naïve or experienced [ Time Frame: Baseline ]
    Proportion pf patients who are injection naïve or experienced (autoinjector or prefilled syringe) is collected.
  • Proportion of participants by reasons for starting KESIMPTA [ Time Frame: Baseline ]
    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
  • Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration [ Time Frame: Week 1, month 1, month 3 ]
    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
  • Patient Confidence [ Time Frame: Baseline ]
    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
  • Overall device satisfaction based on patient self-report and care partner report [ Time Frame: Week 1, month 3 ]
    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.
  • Injection experience based on patient self-report or care partner report [ Time Frame: Week 1, month 1, month 3 ]
    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
  • Time for injection in minutes [ Time Frame: Week 1, month 1, month 3 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis
Official 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
Brief Summary 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

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

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.
Condition Multiple Sclerosis
Intervention Other: Kesimpta
There is no treatment allocation. Patients administered Kesimpta by prescription that have started before inclusion of the patient into the study will be enrolled.
Other Name: ofatumumab
Study Groups/Cohorts Kesimpta
Patients or caregivers of patients administered Kesimpta
Intervention: Other: Kesimpta
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 12, 2022)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05334472
Other Study ID Numbers COMB157GUS13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor Novartis Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2023