Glatiramer acetate in primary progressive multiple sclerosis: results of a multinational, multicenter, double-blind, placebo-controlled trial

What Was Tested

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

To determine whether glatiramer acetate (GA) slows accumulation of disability in primary progressive multiple sclerosis.

Who Took Part

The study group was 943 patients.

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

A total of 943 patients with primary progressive multiple sclerosis were randomized to GA or placebo (PBO) in this 3-year, double-blind trial.

The trial was stopped after an interim analysis by an independent data safety monitoring board indicated no discernible treatment effect on the primary outcome.

How the Study Was Run

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

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

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

A placebo (an inactive look-alike) gave the Glatiramer Acetate group a baseline to be compared against.

The methods mention a period of 3 months.

The primary end point was an intention-to-treat analysis of time to 1- (entry expanded disability status scale, 3.0-5.0) or 0.5-point expanded disability status scale change (entry expanded disability status scale, 5.5-6.5) sustained for 3 months.

Intention-to-treat analyses of disability and magnetic resonance imaging end points were performed.

What Was Measured

The subject headings attached to it are Disability Evaluation, Glatiramer Acetate, Immunosuppressive Agents, International Cooperation, Multiple Sclerosis, Chronic Progressive, Peptides and Proportional Hazards Models.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Glatiramer Acetate in 943 patients in people with multiple sclerosis over 3 months.

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

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2007 (Annals of neurology), a journal based in United States.

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