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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05334472
• Other study ID #: COMB157GUS13
• Status: Completed
• Start date: November 24, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of patients by educational level	Proportion of patients by educational level was collected	Up to 6 months, at the time of survey completion
Secondary	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
Secondary	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
Secondary	Proportion of patients by Multiple Sclerosis Phenotype	Proportion of patients by Multiple Sclerosis Phenotype was collected: RRMS: Relapsing-Remitting Multiple Sclerosis; SPMS: Secondary Progressive Multiple Sclerosis	Up to 6 months, at the time of survey completion
Secondary	Proportion of patients with co-morbidities	Proportion of patients with co-morbidities was collected	Up to 6 months, at the time of survey completion
Secondary	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
Secondary	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
Secondary	Proportion of patients performing preparation activities for injection	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)	Up to 6 months, at the time of survey completion
Secondary	Proportion of participants by site of administration	Proportion of participants by site of administration was collected: thigh; abdomen; upper outer arm	Up to 6 months, at the time of survey completion
Secondary	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
Secondary	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
Secondary	Proportion of participants by reasons for starting KESIMPTA	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	Up to 6 months, at the time of survey completion
Secondary	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
Secondary	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: 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
Secondary	Patient Confidence	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	Up to 6 months, at the time of survey completion
Secondary	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
Secondary	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

External Links

•   Results for COMB157GUS13 that is getting linked from the Novartis Clinical Trials Website