Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial

What Was Tested

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

To evaluate in the Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone (GATE) study whether generic glatiramer acetate (hereafter generic drug) is equivalent to the originator brand glatiramer acetate (hereafter brand drug) product, as measured by imaging and clinical end points, safety, and tolerability.

Why It Was Studied

The patents for the first approved treatments for relapsing-remitting multiple sclerosis are expiring, creating the opportunity to develop generic alternatives.

Who Took Part

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

Participants were patients with relapsing-remitting multiple sclerosis 18 to 55 years old with at least 1 relapse in the prior year and 1 to 15 gadolinium-enhancing brain magnetic resonance imaging lesions.

The last participant completed follow-up December 2, 2013.

How the Study Was Run

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

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

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

More than one site took part, so the participants came from several places.

Randomized, multicenter, double-blind, active and placebo-controlled phase 3 trial.

The setting included academic medical centers and clinical practices.

They were randomized between December 7, 2011, and March 21, 2013.

What Was Measured

PubMed files the paper under topics including Disability Evaluation, Glatiramer Acetate, Immunosuppressive Agents, Magnetic Resonance Imaging, Multiple Sclerosis and Therapeutic Equivalency.

What This Means in Plain Language

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

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2015 (JAMA neurology), a journal based in United States.

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