NCT06251986

A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice

A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice: the CRONOS-MS Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 310 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This was a non-interventional, cross-sectional, multicentric, and nationwide study, based on primary and secondary data collection.

Detailed description

The present study aimed to characterize the use of subcutaneous ofatumumab in a real-world setting. Specifically, the investigation assessed the effectiveness, safety, and treatment adherence associated with subcutaneous ofatumumab in individuals with relapsing forms of multiple sclerosis (RMS) within the Spanish healthcare system. The study used primary and secondary data collection. Primary data collection included information collected using PRO, clinical-reported outcomes (ClinRO), scales or tests and the interview during the study visit. Secondary data collection included existing data from electronic medical records (EMR) or paper-based medical records, collected as part of the routine follow-up of patients with RMS in the clinical practice. Baseline was defined as the date of ofatumumab initiation.

Conditions

• Relapsing Forms of Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	ofatumumab	This is an observational study, there was no treatment allocation.

Timeline

• Start date: 2024-02-26
• Primary completion: 2024-12-23
• Completion: 2024-12-23
• First posted: 2024-02-09
• Last updated: 2025-12-29

Locations

31 sites across 1 country: Spain