Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

NCT05809986 | Recruiting

• 1 other identifier: COMB157GPT04
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 10

Brief Summary

This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.

Conditions

Relapsing Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis; RMS; Ofatumumab; NIS; Portugal

Outcome Measures

Primary Outcomes (1)

• Proportion of patients demonstrating NEDA-3

  Proportion of patients demonstrating No Evidence of Disease Activity (NEDA)-3 (12-24 months) in both cohorts, respectively. NEDA-3 is defined by no confirmed Multiple Sclerosis relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.

  from month 12 up to month 24

Secondary Outcomes (6)

• Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3

  12-24 months

• Multiple Sclerosis Impact Scale Questionnaire (MSIS-29)

  Baseline, Month 12, Month 24

• Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS)

  Baseline, Month 12, Month 24

• Treatment Satisfaction Questionnaire for Multiple Sclerosis (TSQM-9)

  Month 12, Month 24

• Proportion of patients permanently discontinuing Ofatumumab during the study

  up to month 24

Study Arms (2)

Cohort 1: Early treatment arm

All patients who initiated Ofatumumab within 3 years after MS diagnosis (can be treatment-naive or switch).

Other: Ofatumumab

Cohort 2: Late treatment arm

All patients who initiated Ofatumumab with more than 3 years of MS diagnosis.

Other: Ofatumumab

Interventions

Ofatumumab OTHER

There is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis

Also known as: Kesimpta

Cohort 1: Early treatment arm; Cohort 2: Late treatment arm

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

The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and with Ofatumumab treatment in line with the Portuguese label i.e., adult patients with active, relapsing forms of MS.

You may qualify if:

• Patients aged 18 years or older
• Written informed consent obtained before participating in the study.
• Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.
• Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
• Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features).

You may not qualify if:

• Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Amadora, 2720-276, Portugal

RECRUITING

Novartis Investigative Site

Guimarães, 4835-044, Portugal

RECRUITING

Novartis Investigative Site

Leiria, 2410-104, Portugal

RECRUITING

Novartis Investigative Site

Lisbon, 1169 050, Portugal

RECRUITING

Novartis Investigative Site

Lisbon, 1349-019, Portugal

RECRUITING

Novartis Investigative Site

Lisbon, 1649 035, Portugal

RECRUITING

Novartis Investigative Site

Matosinhos Municipality, 4454 513, Portugal

RECRUITING

Novartis Investigative Site

Ponte de Lima, 4990 041, Portugal

RECRUITING

Novartis Investigative Site

Porto, 4200 319, Portugal

RECRUITING

Novartis Investigative Site

Setúbal, 2910-446, Portugal

RECRUITING

MeSH Terms

Interventions

ofatumumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (10)