Clinical trial NCT05334472: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
NIS
KESIMPTA
ofatumumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready
timeFrame: Up to 6 months, at the time of survey completion
Secondary outcomes:
measure: Proportion of patients by US region of residence
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of patients by educational level
timeFrame: Up to 6 months, at the time of survey completion
measure: Patients Determined Disease Steps (PDDS)
timeFrame: Up to 6 months, at the time of survey completion
measure: General Health
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of patients by Multiple Sclerosis Phenotype
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of patients with co-morbidities
timeFrame: Up to 6 months, at the time of survey completion
measure: Importance of healthcare provider (HCP) instructions for first injection
timeFrame: Up to 6 months, at the time of survey completion
measure: Level of anxiety with injections, in general
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of patients performing preparation activities for injection
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of participants by site of administration
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT)
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of patients who are DMT naïve or experienced
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of participants by reasons for starting KESIMPTA
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of participants by reasons to switch from most recent therapy
timeFrame: Up to 6 months, at the time of survey completion
measure: Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration
timeFrame: Up to 6 months, at the time of survey completion
measure: Patient Confidence
timeFrame: Up to 6 months, at the time of survey completion
measure: Overall device satisfaction by treatment duration
timeFrame: Up to 6 months, at the time of survey completion
measure: Overall device satisfaction score of the study participants by DMT experience
timeFrame: Up to 6 months, at the time of survey completion
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: