Actively Recruiting
Ofatumumab in Portuguese Patients with Relapsing Multiple Sclerosis An Observational Study Comparing Early and Late Treatment
Led by Novartis Pharmaceuticals · Updated on 2025-01-14
174
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of Ofatumumab treatment on people with Relapsing Multiple Sclerosis (RMS) in Portugal. This observational study compares patients who started Ofatumumab within 3 years of their RMS diagnosis to those who began treatment more than 3 years after diagnosis. The goal is to understand how effective Ofatumumab is in routine medical care settings. The study includes two groups: one with early treatment initiation and one with later treatment initiation. Patients either started Ofatumumab up to 12 months before joining the study or start it at the time of inclusion. The study collects data over a period of up to 24 months across three main visits. Additional visits may occur if there is worsening of disability scores to confirm changes. Participants will complete questionnaires and assessments including the Multiple Sclerosis Impact Scale and Fatigue Symptoms Questionnaire at the start and during follow-up visits. Researchers will monitor disease activity using the No Evidence of Disease Activity (NEDA-3) measure between 12 and 24 months. Treatment satisfaction and discontinuation rates will also be tracked. The study lasts up to two years per participant, with regular monitoring of disease status and treatment outcomes.
CONDITIONS
Brief Title
Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 patient-reported outcome questionnaires
- Diagnosis of Relapsing Multiple Sclerosis per McDonald Criteria (2017) before starting Ofatumumab
- Treatment with Ofatumumab according to the Portuguese label for adult patients with active RMS
- Patients who started Ofatumumab up to 12 months before study inclusion or are starting at study inclusion
You will not qualify if you...
- Use of investigational drugs during the study or within a time frame covering 5 half-lives before Ofatumumab initiation or until pharmacodynamic effects return to baseline
- Prior use of high efficacy therapies such as Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab, or Alemtuzumab before starting Ofatumumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who receive Ofatumumab as part of their routine medical care are observed to describe the effectiveness of the treatment over time.
3 visits over 24 months with an additional visit if disability status worsens at 12 or 24 months
Trial Site Locations
Total: 10 locations
1
Novartis Investigative Site
Amadora, Portugal, 2720-276
Actively Recruiting
2
Novartis Investigative Site
Guimarães, Portugal, 4835-044
Actively Recruiting
3
Novartis Investigative Site
Leiria, Portugal, 2410-104
Actively Recruiting
4
Novartis Investigative Site
Lisbon, Portugal, 1169 050
Actively Recruiting
5
Novartis Investigative Site
Lisbon, Portugal, 1349-019
Actively Recruiting
6
Novartis Investigative Site
Lisbon, Portugal, 1649 035
Actively Recruiting
7
Novartis Investigative Site
Matosinhos Municipality, Portugal, 4454 513
Actively Recruiting
8
Novartis Investigative Site
Ponte de Lima, Portugal, 4990 041
Actively Recruiting
9
Novartis Investigative Site
Porto, Portugal, 4200 319
Actively Recruiting
10
Novartis Investigative Site
Setúbal, Portugal, 2910-446
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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