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 | Completed

• 1 other identifier: COMB157GES01
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

Relapsing Forms of Multiple Sclerosis

Keywords

RMS; NIS; Spain; ofatumumab

Outcome Measures

Primary Outcomes (1)

• Reductions in the Annualized relapse rate (ARR)

  ARR, defined as the total number of confirmed relapses that occurred during the observation period divided by the total number of patient-years, with the result standardized to a 1-year period. A relapse is defined as new or recurrent symptoms and objective typical findings of MS with a duration of at least 24 h, in the absence of fever or infection and preceded by a stable or improving neurological state for ≥ 30 days

  12 months preceding the initiation of ofatumumab, Baseline

Secondary Outcomes (18)

• Reductions in the ARR in naïve vs previously treated patients

  12 months preceding the initiation of ofatumumab, Baseline

• Reductions in the ARR in previously treated with high-efficacy Disease-modifying treatments (DMT) vs previously treated with moderate-efficacy DMT

  12 months preceding the initiation of ofatumumab, Baseline

• Number of days from ofatumumab treatment initiation to first relapse

  12 months

• Proportion of relapse-free patients

  12 months

• Change in EDSS score

  Baseline, month 6, month 12

Study Arms (1)

ofatumumab

Subcutaneous ofatumumab in a real-world setting

Other: ofatumumab

Interventions

ofatumumab OTHER

This is an observational study, there was no treatment allocation.

ofatumumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with relapsing forms of multiple sclerosis (RMS) with active disease

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (31)

Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain

Location

Novartis Investigative Site

Palma, Balearic Islands, 07120, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Novartis Investigative Site

Santander, Cantabria, 39008, Spain

Location

Novartis Investigative Site

Albacete, Castille-La Mancha, 02006, Spain

Location

Novartis Investigative Site

Salt, Girona, 17190, Spain

Location

Novartis Investigative Site

Logroño, La Rioja, 26006, Spain

Location

Novartis Investigative Site

Fuenlabrada, Madrid, 28942, Spain

Location

Novartis Investigative Site

Majadahonda, Madrid, 28222, Spain

Location

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Novartis Investigative Site

Vigo, Pontevedra, 36212, Spain

Location

Novartis Investigative Site

Santa Cruz, Santa Cruz de Tenerife, 38009, Spain

Location

Novartis Investigative Site

Barakaldo, Vizcaya, 48903, Spain

Location

Novartis Investigative Site

Alicante, 03010, Spain

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

Novartis Investigative Site

Burgos, 09006, Spain

Location

Novartis Investigative Site

Cáceres, 10004, Spain

Location

Novartis Investigative Site

Córdoba, 14004, Spain

Location

Novartis Investigative Site

Granada, 18016, Spain

Location

Novartis Investigative Site

León, 24080, Spain

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Novartis Investigative Site

Madrid, 28034, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Novartis Investigative Site

Málaga, 29010, Spain

Location

Novartis Investigative Site

Seville, 41009, Spain

Location

Novartis Investigative Site

Seville, 41013, Spain

Location

Novartis Investigative Site

Valencia, 46010, Spain

Location

Novartis Investigative Site

Valencia, 46026, Spain

Location

Novartis Investigative Site

Zaragoza, 50009, Spain

Location

Related Links

• Link to study results

MeSH Terms

Interventions

ofatumumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 26, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (31)