At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 284 enrolled
Drug / intervention
ofatumumab with PRF +1 morecombination
Likely dose
ofatumumab with PRF 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 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
In Brief
A Phase 2 clinical trial evaluating ofatumumab with PRF and ofatumumab with AI for Multiple Sclerosis. Completed, enrolled 284 participants across 41 sites in 9 countries.
Detailed Summary
The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3 program and the to-be-marketed drug-device combinations
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesAustria, Bulgaria, Czechia, Estonia, Latvia, Lithuania, Russia, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartSep 2018
Primary CompletionAug 2019
Study CompletionMay 2020
TodayJul 2026
First PostedJun 18, 2018
Enrollment StartSep 11, 2018
Primary CompletionAug 26, 2019
Study CompletionMay 5, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.0 years ago
Interventions
ofatumumab with PRFcombination
ofatumumab 20 mg subcutanious injection administered with pre-filled syringe (PRF)
ofatumumab with AIcombination
ofatumumab 20 mg subcutaneous injection administered with autoinjector (AI)