Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT05809986

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

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study | DecenTrialz