European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group

What Was Tested

The paper reports a study of Glatiramer Acetate in the context of multiple sclerosis, published as a randomized controlled trial.

This study was designed to determine the effect, onset, and durability of any effect of GA on disease activity monitored with magnetic resonance imaging (MRI) in patients with RRMS.

Why It Was Studied

Eligibility required one or more relapses in the 2 years before entry and at least one enhancing lesion on a screening MRI.

The primary outcome measure was the total number of enhancing lesions on T1-weighted images.

Who Took Part

The age groups tagged for this paper are adults, both men and women.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

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

As a double-blind Glatiramer Acetate study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Glatiramer Acetate could be set against what happens without it.

The methods mention a period of 9 months.

What Was Measured

The primary outcome measure was the total number of enhancing lesions on T1-weighted images.

Secondary outcome measures included the proportion of patients with enhancing lesions, the number of new enhancing lesions and change in their volume; the number of new lesions detected on T2-weighted images and change in their volume, and the change in volume of hypointense lesions seen on unenhanced T1-weighted images.

Topics PubMed links to this paper include Glatiramer Acetate, Magnetic Resonance Imaging, Multiple Sclerosis, Relapsing-Remitting, Peptides and Prognosis.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Glatiramer Acetate in people with multiple sclerosis over 9 months.

The publication is from 2001 (Annals of neurology), a journal based in United States.

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