Active, Not RecruitingN/AOther
A Real-World Study of Ofatumumab in Multiple Sclerosis Patients in Germany and Japan
Sponsored by Novartis Pharmaceuticals
NCT ID
NCT07821411
Target Enrollment
5,000 participants
Start Date
2026-07-31
Est. Completion
2026-09-30
About This Study
This study aims to evaluate the real-world persistence and adherence to ofatumumab (OMB) treatment in adult patients with relapsing multiple sclerosis (RMS). This is a non-interventional study using administrative claims data available in Germany and Japan.
Conditions Studied
Eligibility
Age:18 Years - 100 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion criteria: Patients will be included in the OMB or disease modifying treatment (DMT) cohort if they meet the following criteria: * Have an RMS diagnosis including relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS). * Have a new start of OMB or DMT during the inclusion period (any time on or after the RMS diagnosis index date) that was not used during the baseline period (patients may be DMT-naïve or switch to new DMT). * Age 18 years or older at index date. Index date is the date of first claim for OMB or DMT during the inclusion period. * Have a continuous health plan enrollment from the start of the baseline period to 12 months after index date (excluding early death). Exclusion criteria: Patients will be excluded if they meet any of the following criteria: * Have inactive SPMS or primary progressive multiple sclerosis (PPMS). * Have any inpatient or outpatient diagnosis of other demyelinating diseases during the baseline period. Other protocol-defined inclusion/exclusion criteria may apply.
Study Locations (1)
Novartis
Basel, Switzerland