A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis
Study Details
Study Description
Brief Summary
This is a US-based, observational prospective study with primary data collection via a questionnaire directly administered to patients starting KESIMPTA or their care partners assisting with the injection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The study will aim to enroll approximately one-hundred and ten (110) patients/care partners, with a 75% patient/25% care partner split. The time period for enrollment is dependent on the uptake of KESIMPTA in the real-world. Neurologists and advanced practice providers specializing in MS treatment, who are likely to prescribe KESIMPTA based on a referral survey response, will be targeted for recruitment onto the study's physician panel. Recruiting neurologists/advanced practice providers will assess patients for study participation at the time of presentation for a routine clinic visit, according to the defined selection criteria. No clinic visits are required for participation in this study and all eligible patients will be consecutively proposed to be enrolled in the study through physician panel referral.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Kesimpta Patients or caregivers of patients administered Kesimpta |
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 Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready [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®
Secondary Outcome Measures
- Proportion of patients by US region of residence [Baseline]
Census US geographic region of residence (Northeast, Midwest, South, or West)
- Proportion of patients by educational level [Baseline]
Proportion of patients by educational level will be collected
- Patients Determined Disease Steps (PDDS) [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 [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 [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 [Baseline]
Proportion of patients with co-morbidities is collected
- Importance of healthcare provider (HCP) instructions for first injection [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 [Baseline]
Proportion of participants with necessity of Health Care Professional (HCP) at first injection is collected
- Level of anxiety with injections, in general [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 [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 [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) [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 [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 [Baseline]
Proportion pf patients who are injection naïve or experienced (autoinjector or prefilled syringe) is collected.
- Proportion of participants by reasons for starting KESIMPTA [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 [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 [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 [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 [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 [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
Eligibility Criteria
Criteria
Patients with MS Inclusion Criteria:
-
Adult aged eighteen (18) years of age or over
-
Newly prescribed KESIMPTA and intends to self-administer treatment using the Sensoready® pen
-
MS diagnosis based on 2017 McDonald criteria
-
Willing and able to give informed consent for participation
Care Partner Inclusion Criteria:
-
Adult aged eighteen (18) years of age or over
-
Formal or informal care partner of patient with MS newly prescribed KESIMPTA
-
Intends to administer KESIMPTA using the Sensoready® pen on their patient's behalf
-
Willing and able to give informed consent for participation
Patients with MS Exclusion Criteria:
Patients meeting ANY of the following criteria are not eligible for participation:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | East Hanover | New Jersey | United States | 07936 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COMB157GUS13