Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab [amount hidden] vs. First Line DMT in RMS

What Was Tested

This registered phase 3 trial tested Glatiramer Acetate for multiple sclerosis.

This study will compare ofatumumab vs.

European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients.

It had two arms (groups): ofatumumab (experimental) and First line DMT (active comparator).

The registry classes the interventions as drug.

More on the Plan

There is a screening period and patients are randomized to either ofatumumab or first line DMT at baseline.

Patients will be treated until the end of study (EOS) or for a maximum duration of 15 months.

Patients who prematurely discontinue study drug or comparator will have their end of treatment (EOT) visit and assessments at the time of discontinuation.

After ofatumumab or the standard of care comparator (DMT) discontinuation, patients may initiate alternative MS therapy according to local standard of care, if clinically indicated.

Who Took Part

185 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written informed consent obtained before any assessment. Male/female patients, 18 through 55 (inclusive) years of age. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018). Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014. Treatment Naïve patients, ≤ 5 years since first MS symptom.

The full record lists 10 inclusion and 28 exclusion criteria; among the exclusions: diseases other than multiple sclerosis responsible for the clinical or mri presentation; progressive ms phenotypes: patients with primary progressive ms (polman et al 2011) or spms (lublin et al 2014); relapse between screening and baseline visits.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The multiple sclerosis participants were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

Only one side, usually the multiple sclerosis participants, was kept unaware of whether Glatiramer Acetate was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2021-07-23 with completion listed for 2025-11-04.

It ran at 41 sites in France (13), Germany (11), Spain (11) and Italy (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of participants with no evidence of disease activity (NEDA-3) (time frame: Baseline to 15 month).

It also tracked 17 secondary outcomes, for example Number of relapses, Annual relapse rate, Percentage of relapse-free patients and proportion of relapse free patients with MRI activity free, Time to 3 month Confirmed Disability Worsening (CDW) and time to 6-month Confirmed Disability Worsening (CDW), Change in expanded disability status scale (EDSS) and Percentage of disability-progression free patients.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 185 people with multiple sclerosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.