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: Sep 16, 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.
Interventions
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
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]