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.
This was a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
562
Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)
Annualized Relapse Rate (ARR)
ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient (adjusted for time-in-study by patient). Confirmed relapses are those accompanied by a clinically relevant change in the expanded disability status scale (EDSS). ARR was estimated from fitting a negative binomial regression model with log-link, and adjusted for prior MS therapies as a factor, number of relapses in previous year, baseline EDSS, baseline number of T1 Gd-enhancing lesions and the subject's age at baseline as covariates. The primary analysis describes the ARR with one-sided 95% confidence bound and test for null hypothesis (H0): ARR \>=0.18 versus alternative hypothesis (H1): ARR\<0.18.
Time frame: Up to 96 weeks from baseline
Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of of participants with treatment emergent AEs and SAEs including injection related reactions, abnormal laboratory results or vital signs reported and qualifying as AEs.
Time frame: From treatment day 1 to 100 days after last treatment up to approximatelly 26.6 months
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