Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results

What Was Tested

Researchers studied Glatiramer Acetate in this randomized controlled trial publication.

Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone® (GATE) trial.

Who Took Part

The study group was 729 patients.

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

How the Study Was Run

The researchers set it up as a randomized, double-blind, open-label 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.

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

Nothing was hidden in this open-label Glatiramer Acetate study: the patients and staff both knew the treatment.

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

Safety was assessed at months 12, 15, 18, 21, and 24 and Expanded Disability Status Scale and magnetic resonance imaging (MRI) scans at months 12, 18, and 24.

The presence of glatiramer anti-drug antibodies (ADAs) was tested at baseline and months 1, 3, 6, 9, 12, 18, and 24.

What Was Measured

PubMed files the paper under topics including Drug Substitution, Drugs, Generic, Glatiramer Acetate, Image Enhancement, Immunosuppressive Agents, Magnetic Resonance Imaging and Multiple Sclerosis.

The authors tagged it with the keywords clinical trial and equivalence.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Glatiramer Acetate in 729 patients.

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

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2017 (Multiple sclerosis (Houndmills, Basingstoke, England)), a journal based in England.

More context: the Glatiramer Acetate compound page, all human trials.