United States open-label glatiramer acetate extension trial for relapsing multiple sclerosis: MRI and clinical correlates. Multiple Sclerosis Study Group and the MRI Analysis Center

What Was Tested

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

After the placebo-controlled extension of the pivotal US trial of glatiramer acetate for the treatment of relapsing multiple sclerosis ended, 208 participants entered an open-label, long-term treatment protocol Magnetic resonance imaging (MRI) was added to the planned evaluations of these subjects to determine the consequences of long-term treatment on MRI-defined pathology and evaluate its clinical correlates.

Why It Was Studied

Of the 147 subjects that remained on long-term follow-up, adequate images were obtained on 135 for quantitative MRI analysis.

The initial imaging sessions were performed between June 1998 and January 1999 at 2,447 +/- 61 days (mean +/- standard deviation) after the subject's original randomization.

Who Took Part

The study group was 208 participants.

By PubMed's age tags, the people studied were adults and middle-aged adults, both men and women.

How the Study Was Run

The researchers set it up as 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.

Neither the participants nor the staff measuring them knew who was on Glatiramer Acetate, so expectations could not easily colour the readings.

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

Some participants received a placebo instead of Glatiramer Acetate, giving a reference point.

What Was Measured

Topics PubMed links to this paper include Autoimmune Diseases, Brain, Cohort Studies, Glatiramer Acetate, Image Processing, Computer-Assisted, Immunosuppressive Agents and Magnetic Resonance Imaging.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Glatiramer Acetate in 208 participants in people with multiple sclerosis.

The publication is from 2001 (Multiple sclerosis (Houndmills, Basingstoke, England)), a journal based in England.

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