A multicentre, prospective, randomized, open-label pragmatic trial to compare the effectiveness and safety of interferon beta-1a and glatiramer-acetate in paediatric patients affected by Multiple Sclerosis

What Was Tested

Researchers studied Glatiramer Acetate in the context of multiple sclerosis in this randomized controlled trial publication.

Paediatric-onset Multiple Sclerosis (POMS) is a rare, highly active disease requiring timely disease-modifying therapy.

Who Took Part

According to the abstract, 30 participants were involved.

By PubMed's age tags, the people studied were children and teenagers, both men and women.

A 96-week, Phase IIIb, multicenter, open-label randomized trial enrolled 30 participants (ages 12-17).

Patients were randomized into two groups: 15 received i.m.

How the Study Was Run

The researchers set it up as a randomized, open-label and multicenter study.

Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.

Being open-label, the Glatiramer Acetate study did not mask who received what.

Running at several centres spread the Glatiramer Acetate study over different clinics and patient groups.

IFN-beta 1a, and 15 received s.c.

The primary endpoint was MRI disease activity-free status; secondary outcomes included annualized relapse rate (ARR), time to first relapse, Expanded Disability Status Scale (EDSS), cognitive and fatigue scores, and quality of life.

What Was Measured

PubMed files the paper under topics including Glatiramer Acetate, Interferon beta-1a, Multiple Sclerosis, Immunologic Factors and Quality of Life.

The authors tagged it with the keywords POMS, Phase III randomized clinical trial and Pragmatic study.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Glatiramer Acetate in 30 participants in people with multiple sclerosis.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2025 (Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology), a journal based in Italy.

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