Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial

What Was Tested

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

Who Took Part

The abstract describes 481 patients taking part.

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

The randomisation scheme used SAS-based blocks stratified by centre, and patients and all personnel were masked to treatment assignment.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

The primary endpoint was time to clinically definite multiple sclerosis, based on a second clinical attack.

Analysis was by intention to treat.

This study was registered with ClinicalTrials.gov, number NCT00666224.

What Was Measured

Topics PubMed links to this paper include Analysis of Variance, Disease Progression, Glatiramer Acetate, Immunosuppressive Agents, Kaplan-Meier Estimate, Magnetic Resonance Imaging and Multiple Sclerosis, Relapsing-Remitting.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Glatiramer Acetate in 481 patients in people with multiple sclerosis.

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

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2009 (Lancet (London, England)), a journal based in England.

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