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

Last updated: February 6, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

ofatumumab

Clinical Study ID

NCT06251986
COMB157GES01
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 productcharacteristics (SmPC; i.e. adult patients with RMS with active disease defined byclinical or imaging features) during at least 12 months and patients whodiscontinued ofatumumab after receiving at least one dose with a minimum monitoringof 12 months.

Exclusion

Exclusion Criteria:

  1. Currently participating in a clinical trial.

  2. Not able/unlikely to complete with all study activities according to investigator'scriteria.

  3. Have a contraindication for ofatumumab use, according to the SmPC.

Study Design

Total Participants: 311
Treatment Group(s): 1
Primary Treatment: ofatumumab
Phase:
Study Start date:
February 26, 2024
Estimated Completion Date:
December 16, 2024

Study Description

The present study aims to characterize the use of subcutaneous ofatumumab in a real-world setting. Specifically, the investigation will assess 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 will use primary and secondary data collection. Primary data collection includes information collected using PRO, clinical-reported outcomes (ClinRO), scales or tests and the interview during the study visit. Secondary data collection includes 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 will be defined as the date of ofatumumab initiation.

Connect with a study center

  • Novartis Investigative Site

    Cordoba, Andalucia 14004
    Spain

    Site Not Available

  • Novartis Investigative Site

    Malaga, Andalucia 29010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Sevilla, Andalucia 41013
    Spain

    Site Not Available

  • Novartis Investigative Site

    Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Novartis Investigative Site

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Novartis Investigative Site

    Albacete, Castilla La Mancha 02006
    Spain

    Site Not Available

  • Novartis Investigative Site

    Salt, Cataluna 17190
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08036
    Spain

    Site Not Available

  • Novartis Investigative Site

    Alicante, Comunidad Valenciana 03010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Zamora, Espana 49022
    Spain

    Site Not Available

  • Novartis Investigative Site

    Santiago De Compostela, Galicia 15706
    Spain

    Site Not Available

  • Novartis Investigative Site

    Palma De Mallorca, Islas Baleares 07120
    Spain

    Site Not Available

  • Novartis Investigative Site

    Logrono, La Rioja 26006
    Spain

    Site Not Available

  • Novartis Investigative Site

    Fuenlabrada, Madrid 28942
    Spain

    Site Not Available

  • Novartis Investigative Site

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Novartis Investigative Site

    Vigo, Pontevedra 36212
    Spain

    Site Not Available

  • Novartis Investigative Site

    Baracaldo, Vizcaya 48903
    Spain

    Site Not Available

  • Novartis Investigative Site

    Burgos, 09006
    Spain

    Site Not Available

  • Novartis Investigative Site

    Caceres, 10004
    Spain

    Site Not Available

  • Novartis Investigative Site

    Granada, 18016
    Spain

    Site Not Available

  • Novartis Investigative Site

    Leon, 24080
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28222
    Spain

    Site Not Available

  • Novartis Investigative Site

    Santa Cruz de Tenerife, 38009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Zaragoza, 50009
    Spain

    Site Not Available

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