250 microg or 500 microg interferon beta-1b versus [amount hidden] glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study

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

According to the abstract, 2005, patients were involved.

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

Between November, 2003, and June, 2005, 2447 patients with relapsing-remitting multiple sclerosis were screened and 2244 patients were enrolled in this prospective, multicentre, randomised trial.

How the Study Was Run

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

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

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

Running at several centres spread the Glatiramer Acetate study over different clinics and patient groups.

The primary outcome was relapse risk, defined as new or recurrent neurological symptoms separated by at least 30 days from the preceding event and that lasted at least 24 h.

Secondary outcomes were progression on the expanded disability status scale (EDSS) and change in T1-hypointense lesion volume.

Clinical outcomes were assessed quarterly for 2.0-3.5 years; MRI was done at screening and annually thereafter.

Analysis was by per protocol.

This study is registered, number NCT00099502.

What Was Measured

PubMed files the paper under topics including Brain, Glatiramer Acetate, Immunologic Factors, Interferon beta-1b, Interferon-beta, Magnetic Resonance Imaging and Multiple Sclerosis, Relapsing-Remitting.

What This Means in Plain Language

The paper is a randomized, double-blind and multicenter study of Glatiramer Acetate in 2005, 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 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

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

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