Phase
Condition
Multiple Sclerosis
Memory Loss
Scar Tissue
Treatment
Ofatumumab
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with relapsing multiple sclerosis (RMS) with disease activity defined byclinical assessment or MRI analysis.
Written informed consent must be obtained before participating in the study.
Patient is willing and able to complete the assessments, as outlined in this study.
Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation ofOfatumumab.
Patients in both cohorts must have been on treatment with Ofatumumab for at least 3months, but not longer than 12 months prior to inclusion in the study.
Cohort 1: Patients that, before initiation of Ofatumumab, were either treatmentnaive or have started their treatment for RMS with another disease modifying therapy (BRACE, teriflunomide or fumarates). Non-naive patients in this cohort must havestarted the use of Ofatumumab within 3 years after first DMT initiation.
Cohort 2: Patients must have been on either BRACE or Teriflunomide or fumarates forat least three years or longer before the switch to Ofatumumab has been initiated.Thus, this cohort includes patients that use Ofatumumab as second or later line DMT.
Exclusion
Exclusion Criteria:
Patients who have been on Ofatumumab less than 3 months or more than 12 monthsbefore inclusion.
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 any high efficacy therapy (including Fingolimod, Siponimod, Ponesimod,Ozanimod, Rituximab, Ocrelizumab, Natalizumab, Alemtuzumab, Mitoxantron orCladribine) in either cohort prior to the initiation of Ofatumumab.
Previous use of any DMTs other than BRACE, Teriflunomide or fumarates prior to theinitiation of Ofatumumab.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Mistelbach, 2130
AustriaActive - Recruiting
Novartis Investigative Site
Vienna, A 1090
AustriaActive - Recruiting
Novartis Investigative Site
Wels, 4600
AustriaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.