Ireland
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Active, not recruiting Observational

A Real-World Study of Ofatumumab in Multiple Sclerosis Patients in Germany and Japan

NCT07821411 · tracked via the Priya Life Science Switzerland tracker
Phase
Observational
Started
2026-07-31
Last updated
2026-09-15

Condition(s) studied

Multiple Sclerosis

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Proportion of Patients Persistent With OMB — 6 months, 12 months
    Persistence is defined as the absence of evidence of treatment switch or discontinuation at pre-defined timepoints of interest (6 months, 12 months follow-up).
  • Proportion of Patients Adherent to OMB — 6 months, 12 months
    Adherence measured using the proportion of days covered (PDC). PDC is defined as the number of days covered by the treatment divided by the period considered in the analysis, including overlaps between prescriptions.

Trial sites (1)

FacilityCityRegionStatus
Novartis Basel Switzerland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07821411 on ClinicalTrials.gov ↗ ← All trials in Switzerland