CompletedNot Applicable

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

Spain310 participantsStarted 2024-02-26

Plain-language summary

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

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Aged ≥ 18 years.
✓. Written informed consent.
✓. Diagnosis of RMS per McDonald Criteria (2017).
✓. 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.

✕. Currently participating in a clinical trial.
✕. Not able/unlikely to complete with all study activities according to investigator's criteria.
✕. Have a contraindication for ofatumumab use, according to the SmPC.

Reductions in the Annualized relapse rate (ARR)

Timeframe: 12 months preceding the initiation of ofatumumab, Baseline

NCT IDNCT06251986

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-23