Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
ConditionRelapsing Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ofatumumab
Treatment groups
174 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov