Actively Recruiting
Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Led by Novartis Pharmaceuticals · Updated on 2025-01-14
174
Participants Needed
10
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 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 with active disease defined by clinical or imaging features)
- Patients that have initiated Ofatumumab up to 12 months prior to inclusion in the study OR patients initiating Ofatumumab at study inclusion
You will not qualify if you...
- Use of investigational drugs during the study, or between Ofatumumab initiation and inclusion into the study, or within 5 half-lives of investigational drug before Ofatumumab initiation, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) prior to initiation of Ofatumumab
AI-Screening
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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
CONTACT
N
Novartis Pharmaceuticals
CONTACT
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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