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

Launched by NOVARTIS PHARMACEUTICALS · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a medication called Ofatumumab (brand name Kesimpta®) for patients with a type of multiple sclerosis known as relapsing forms of multiple sclerosis (RMS). The study is being conducted across various locations in Spain and involves gathering information from patients who have been treated with Ofatumumab for at least a year. Researchers want to understand how well this treatment works in real-world settings and how it affects patients in their daily lives.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of RMS. They should have been receiving Ofatumumab treatment for active disease for at least 12 months or have previously received the treatment for a minimum of one dose followed by 12 months of monitoring after stopping the medication. Participants will be asked to provide their experiences and health information related to the treatment. It’s important to note that individuals currently involved in other clinical trials or those who cannot complete the study requirements may not be eligible. This study aims to provide valuable insights that could help improve treatment options for people living with RMS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged ≥ 18 years.
• • 2. Written informed consent.
• • 3. Diagnosis of RMS per McDonald Criteria (2017).
• • 4. Ofatumumab treatment in line with the European Kesimpta® summary of product characteristics (SmPC; i.e. adult patients with RMS with active disease defined by clinical or imaging features) during at least 12 months and patients who discontinued ofatumumab after receiving at least one dose with a minimum monitoring of 12 months.
• Exclusion Criteria:
• • 1. Currently participating in a clinical trial.
• • 2. Not able/unlikely to complete with all study activities according to investigator's criteria.
• • 3. Have a contraindication for ofatumumab use, according to the SmPC.