Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Recruiting · NCT05809986 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
Ofatumumab
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
10 locations listed.
- Novartis Investigative Site - Amadora, Portugal
- Novartis Investigative Site - Guimarães, Portugal
- Novartis Investigative Site - Leiria, Portugal
- Novartis Investigative Site - Lisbon, Portugal
- Novartis Investigative Site - Lisbon, Portugal
- Novartis Investigative Site - Lisbon, Portugal
- Novartis Investigative Site - Matosinhos Municipality, Portugal
- Novartis Investigative Site - Ponte de Lima, Portugal
- Novartis Investigative Site - Porto, Portugal
- Novartis Investigative Site - Setúbal, Portugal