Phase
Condition
Neurologic Disorders
Memory Loss
Multiple Sclerosis
Treatment
Ofatumumab
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 PROquestionnaires, as outlined in this study.
Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation ofOfatumumab.
Treatment with Ofatumumab is in accordance with the Portuguese indication ofKesimpta® (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 ORPatients that are initiating Ofatumumab at the moment of study inclusion.
Exclusion
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 andinclusion into the study, OR within 5 half-lives of investigational drug beforeOfatumumab initiation, OR until the expected pharmacodynamic effect has returned tobaseline, whichever is longer.
Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone,Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Amadora, 2720-276
PortugalActive - Recruiting
Novartis Investigative Site
Guimaraes, 4835-044
PortugalActive - Recruiting
Novartis Investigative Site
Leiria, 2410-104
PortugalActive - Recruiting
Novartis Investigative Site
Lisboa, 1349-019
PortugalActive - Recruiting
Novartis Investigative Site
Matosinhos, 4454 513
PortugalActive - Recruiting
Novartis Investigative Site
Ponte de Lima, 4990 041
PortugalActive - Recruiting
Novartis Investigative Site
Porto, 4200 319
PortugalActive - Recruiting
Novartis Investigative Site
Setubal, 2910-446
PortugalActive - Recruiting
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