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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.
This was a non-interventional, cross-sectional, multicentric, and nationwide study, based on primary and secondary data collection.
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.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Palma, Balearic Islands, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Santander, Cantabria, Spain
Novartis Investigative Site
Albacete, Castille-La Mancha, Spain
Novartis Investigative Site
Salt, Girona, Spain
Novartis Investigative Site
Logroño, La Rioja, Spain
Novartis Investigative Site
Fuenlabrada, Madrid, Spain
Novartis Investigative Site
Majadahonda, Madrid, Spain
Novartis Investigative Site
Pamplona, Navarre, Spain
Start Date
February 26, 2024
Primary Completion Date
December 23, 2024
Completion Date
December 23, 2024
Last Updated
December 29, 2025
310
ACTUAL participants
ofatumumab
OTHER
Lead Sponsor
Novartis Pharmaceuticals
NCT06681623
NCT04676555
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01201356