NCT05776888

Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years

Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years- A Non-interventional Observational Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This non-interventional study aims to observe the effect of early versus late Ofatumumab treatment in RMS patients in a real-world setting in Austria over an observational period of 24 months.

Detailed description

This multi-center, observational study will describe the effects of Ofatumumab in 2 cohorts in a routine medical care setting. Cohort one will comprise patients who have started Ofatumumab early during their disease (treatment naive patients or those that started Ofatumumab within 3 years of first therapy initiation). Cohort two will include patients who have been on other DMTs (one or several) for a minimum of 3 years prior to switching to Ofatumumab. Patients in both cohorts will be observed for two years.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Ofatumumab	There is no treatment allocation. For both cohorts, only patients that have received Ofatumumab treatment for at least 3 months prior to inclusion in the study will be enrolled.

Timeline

• Start date: 2023-07-10
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2023-03-20
• Last updated: 2025-12-30