An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab
Phase 3
- Conditions
- Relapsing Multiple SclerosisMS
- Registration Number
- LBCTR2021034775
- Lead Sponsor
- ovartis Pharma Services Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Inclusion Criteria:
Diagnosis of multiple sclerosis (MS)
Relapsing MS (RRMS or SPMS) course
Subject transitioning from either fingolimod or dimethyl fumarate, following min 6 months treatment with either drug
Breakthrough disease as evidence by clinical relapses or MRI
EDSS score of 0 to 4
Exclusion Criteria
Primary progressive MS or SPMS without disease activity
Disease duration of more than 10 years since diagnosis
Patients with an active chronic disease of the immune system other than MS
Patients at risk of developing or having reactivation of hepatitis
Patients with active systemic infections or with neurological findings consistent with PML Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: Annual Relapse Rate;Timepoints: 96 weeks;Measure: number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient
- Secondary Outcome Measures
Name Time Method ame: Safety evaluation;Timepoints: 96 weeks;Measure: Proportion of patients with adverse events, including injection related reactions, abnormal laboratory results or vital signs as well as proportion of patients discontinuing treatment due to insufficient effectiveness or safety