Long-term follow-up of patients treated with glatiramer acetate: a multicentre, multinational extension of the European/Canadian double-blind, placebo-controlled, MRI-monitored trial

What Was Tested

This randomized controlled trial paper looks at Glatiramer Acetate.

The European/Canadian GA study consisted of two consecutive phases, each lasting nine months.

For the long-term follow-up (LTFU), dual echo, pre- and postgadolinium T1-weighted brain MRI scans were obtained with the same acquisition scheme as for the original trial and a neurological assessment was performed.

Who Took Part

The abstract describes 224 patients taking part.

The age groups tagged for this paper are adults.

The first treatment phase was randomized, double-blind and placebo-controlled.

How the Study Was Run

In design terms this was a randomized, double-blind, open-label and placebo-controlled study.

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

Blinding on both sides kept the patients and researchers unaware of who received Glatiramer Acetate.

Nothing was hidden in this open-label Glatiramer Acetate study: the patients and staff both knew the treatment.

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

What Was Measured

For the long-term follow-up (LTFU), dual echo, pre- and postgadolinium T1-weighted brain MRI scans were obtained with the same acquisition scheme as for the original trial and a neurological assessment was performed.

PubMed files the paper under topics including Age of Onset, Brain, Glatiramer Acetate, Immunosuppressive Agents, Magnetic Resonance Imaging, Multiple Sclerosis, Relapsing-Remitting and Peptides.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Glatiramer Acetate in 224 patients.

The publication is from 2007 (Multiple sclerosis (Houndmills, Basingstoke, England)), a journal based in England.

More context: the Glatiramer Acetate compound page, all human trials.