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

Real World Study to Evaluate Patient and Care Partner Ratings on Early Experience of Injection and Device for KESIMPTA® (Ofatumumab) Indicated for Multiple Sclerosis

ClinicalTrials.gov Identifier: NCT05334472

Novartis Reference Number: COMB157GUS13

Last Update: Apr 19, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Multiple Sclerosis

Phase

Not Given

Overall status

Recruiting

Start date

Nov 24, 2021

Completion date

Aug 08, 2022

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

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

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

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.

Eligibility 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