Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial

What Was Tested

This randomized controlled trial paper looks at Glatiramer Acetate in the context of multiple sclerosis.

Their aim in the REGARD (REbif vs Glatiramer Acetate in Relapsing MS Disease) study was to compare interferon beta-1a with glatiramer acetate in patients with RRMS.

A subpopulation of 460 patients (230 from each group) also had serial MRI scans to assess T2-weighted and gadolinium-enhancing lesion number and volume.

Why It Was Studied

Interferon beta-1a and glatiramer acetate are commonly prescribed for relapsing-remitting multiple sclerosis (RRMS), but no published randomised trials have directly compared these two drugs.

Who Took Part

According to the abstract, 460 patients were involved.

The age groups tagged for this paper are teenagers, adults and middle-aged adults, both men and women.

Treatments were assigned by a computer-generated randomisation list that was stratified by centre.

How the Study Was Run

In design terms this was a randomized, open-label, multicenter and parallel-group study.

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

Everyone knew when Glatiramer Acetate was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

More than one site took part, so the patients came from several places.

Groups ran in parallel: each of the patients stayed in one arm throughout.

Analysis was by intention to treat.

This trial is registered with ClinicalTrials.gov, number NCT00078338.

What Was Measured

Topics PubMed links to this paper include Confidence Intervals, Disability Evaluation, Disease Progression, Glatiramer Acetate, Immunologic Factors, Interferon beta-1a and Interferon-beta.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Glatiramer Acetate in 460 patients in people with multiple sclerosis.

With several hundred people or more, it is a fairly large study for this kind of research.

Its findings take up roughly 8 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2008 (The Lancet. Neurology), a journal based in England.

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