Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS

What Was Tested

This registered phase 4 trial tested Glatiramer Acetate for multiple sclerosis.

Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

91 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria. Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required. Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive. Patients must be between the ages of 18 and 50 years inclusive. Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit.

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry; previous treatment with glatiramer acetate (injectable); previous total body irradiation or total lymphoid irradiation.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The multiple sclerosis participants were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

Everyone knew when Glatiramer Acetate was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2004-07 with completion listed for 2007-10.

Its stated primary purpose is prevention.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 91 people with multiple sclerosis.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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