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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-24

Study Completion Date

2023-02-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kesimpta

Patients or caregivers of patients administered Kesimpta

Kesimpta

Intervention Type OTHER

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

Interventions

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Kesimpta

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

Intervention Type OTHER

Other Intervention Names

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ofatumumab

Eligibility Criteria

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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

* 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No