Effects of oral glatiramer acetate on clinical and MRI-monitored disease activity in patients with relapsing multiple sclerosis: a multicentre, double-blind, randomised, placebo-controlled study

What Was Tested

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

Who Took Part

The study group was 1912 patients.

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

After baseline investigation, clinical assessments were done every 2 months and MRI was obtained for all patients at baseline and at study exit.

Additionally, MRI was undertaken every 2 months for a cohort of 486 patients.

How the Study Was Run

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

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

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

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

The primary outcome was the total number of confirmed relapses observed during the study period.

What Was Measured

Topics PubMed links to this paper include Confidence Intervals, Glatiramer Acetate, Immunosuppressive Agents, Magnetic Resonance Imaging, Multiple Sclerosis, Chronic Progressive and Peptides.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Glatiramer Acetate in 1912 patients in people with multiple sclerosis.

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

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2006 (The Lancet. Neurology), a journal based in England.

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