A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice
NCT ID: NCT06251986
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
310 participants
OBSERVATIONAL
2024-02-26
2024-12-23
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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ofatumumab
Subcutaneous ofatumumab in a real-world setting
ofatumumab
This is an observational study, there was no treatment allocation.
Interventions
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ofatumumab
This is an observational study, there was no treatment allocation.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Vigo, Pontevedra, Spain
Novartis Investigative Site
Santa Cruz, Santa Cruz de Tenerife, Spain
Novartis Investigative Site
Barakaldo, Vizcaya, Spain
Novartis Investigative Site
Alicante, , Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Burgos, , Spain
Novartis Investigative Site
Cáceres, , Spain
Novartis Investigative Site
Córdoba, , Spain
Novartis Investigative Site
Granada, , Spain
Novartis Investigative Site
León, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Málaga, , Spain
Novartis Investigative Site
Seville, , Spain
Novartis Investigative Site
Seville, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Zaragoza, , Spain
Countries
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Related Links
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Link to study results
Other Identifiers
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COMB157GES01
Identifier Type: -
Identifier Source: org_study_id