At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 562 enrolled
Drug / intervention
Ofatumumabbiological
Likely dose
Ofatumumab 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod
In Brief
A Phase 3 clinical trial evaluating Ofatumumab for Relapsing Multiple Sclerosis. Completed, enrolled 562 participants across 123 sites in 27 countries.
Detailed Summary
Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesArgentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Estonia, Germany, Greece, Hungary, Italy, Latvia, Lebanon, Mexico, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedApr 2020
Enrollment StartJul 2020
Primary CompletionOct 2024
Study CompletionMar 2025
TodayJul 2026
First PostedApr 20, 2020
Enrollment StartJul 14, 2020
Primary CompletionOct 9, 2024
Study CompletionMar 11, 2025
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.2 years ago
Interventions
Ofatumumabbiological
Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)