Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Recruiting now
Conditions studied: Relapsing Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT05809986
- Run by
- Novartis Pharmaceuticals
- People needed
- 174
- Starts
- 2023-11-27
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To participate in the study, all the following inclusion criteria must be met:
- 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).
- Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.
You may not qualify if…
- To participate in the study, none of the following exclusion criteria must be met:
- 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) in both cohorts prior to the initiation of Ofatumumab.
Where it is running
- Novartis Investigative Site — Amadora, Portugal (enrolling)
- Novartis Investigative Site — Guimarães, Portugal (enrolling)
- Novartis Investigative Site — Leiria, Portugal (enrolling)
- Novartis Investigative Site — Lisbon, Portugal (enrolling)
- Novartis Investigative Site — Lisbon, Portugal (enrolling)
- Novartis Investigative Site — Lisbon, Portugal (enrolling)
- Novartis Investigative Site — Matosinhos Municipality, Portugal (enrolling)
- Novartis Investigative Site — Ponte de Lima, Portugal (enrolling)
- Novartis Investigative Site — Porto, Portugal (enrolling)
- Novartis Investigative Site — Setúbal, Portugal (enrolling)
Full record on ClinicalTrials.gov
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