Efficacy and Safety of GTR in Comparison to Copaxone®

What Was Tested

In this phase 3 trial, researchers set out to test Glatiramer Acetate for multiple sclerosis.

It had three arms (groups): GTR (experimental), Copaxone® (active comparator) and Placebo (placebo comparator).

Drug.

Drug.

Drug.

The registry classes the interventions as drug.

Who Took Part

794 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Willing and able to sign written Informed Consent;. Female and male subjects aged 18-55 years inclusive at the time of Informed Consent signing;. Diagnosis of RRMS according to the revised McDonald criteria;. Expanded Disability Status Scale (EDSS) score of 0.0 up to and including 5.5;. Neurologically stable with no evidence of relapse within 30 days prior to randomization;.

The full record lists 10 inclusion and 28 exclusion criteria; among the exclusions: positive laboratory test results for human immunodeficiency virus (hiv), hbsag or hcv at screening;; having been treated with or having received; at any time:.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and investigator.

It started in 2011-10 with completion listed for 2015-01.

It ran at 133 sites in Russia (26), Ukraine (23), Poland (12), Bulgaria (8), United States (7) and Belarus (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (time frame: 9 months).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 794 people with multiple sclerosis.

With 794 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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