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

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Kesimpta

Study type: Observational

Funder types: Industry

Identifiers

NCT05334472

COMB157GUS13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

105 participants in 1 patient group

Kesimpta

Description:

Patients or caregivers of patients administered Kesimpta

Treatment:

Other: Kesimpta