Compares ofatumumab timing in Portuguese adults with relapsing multiple sclerosis
Compares ofatumumab treatment in adults with relapsing multiple sclerosis by time since diagnosis.
Plain-language title generated from the registry record
Registry title: Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Key facts
- Where
- Amadora, Guimarães, Leiria, Lisbon, Matosinhos Municipality, Ponte de Lima, Porto, and Setúbal, PortugalSee the 8 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT05809986, who can take part
Where in Portugal
- AmadoraAmadora, PortugalTaking people
- GuimarãesGuimarães, PortugalTaking people
- LeiriaLeiria, PortugalTaking people
- LisbonLisbon, PortugalTaking people
- Matosinhos MunicipalityMatosinhos Municipality, PortugalTaking people
- Ponte de LimaPonte de Lima, PortugalTaking people
- PortoPorto, PortugalTaking people
- SetúbalSetúbal, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT05809986
- Record updated
- 7 July 2026
- Original description
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.Read full original descriptionShow less
Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
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.
Inclusion: 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: 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; To participate in the study, none of the following exclusion criteria must be met:.