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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

NCT06251986

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Relapsing Forms of Multiple Sclerosis

Interventions: ofatumumab

Countries: Spain

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

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (31)

Santiago Compostela, A Coruna, Spain
Palma, Balearic Islands, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Santander, Cantabria, Spain
Albacete, Castille-La Mancha, Spain
Salt, Girona, Spain
Logroño, La Rioja, Spain
Fuenlabrada, Madrid, Spain
Majadahonda, Madrid, Spain
Pamplona, Navarre, Spain
Vigo, Pontevedra, Spain
Santa Cruz, Santa Cruz de Tenerife, Spain
Barakaldo, Vizcaya, Spain
Alicante, Spain
Barcelona, Spain
Burgos, Spain
Cáceres, Spain
Córdoba, Spain
Granada, Spain
León, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Málaga, Spain
Seville, Spain
Seville, Spain
Valencia, Spain
Valencia, Spain
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