Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

What Was Tested

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

This was a multicenter, randomized, open-label, parallel-group, active-controlled study.

It had three arms (groups): Natalizumab (experimental), Interferon Beta-1a (active comparator) and Glatiramer Acetate (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 84 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Have a diagnosis of relapsing remitting multiple sclerosis (MS) as defined by the revised McDonald Committee criteria (Polman 2005). One or more clinical relapses OR. Be naïve to natalizumab. Have a documented Expanded Disability Status Scale (EDSS) score between 0.0 and 5.5, inclusive.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: have known intolerance, contraindication to, or history of non-compliance with, the use of glatiramer acetate or interferon beta-1a; known history of human immunodeficiency virus (hiv); history of transplantation or any anti-rejection therapy.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Glatiramer Acetate study did not mask who received what.

It started in 2010-03 with completion listed for 2012-04.

It ran at 42 sites in United States (19), Spain (6), Hungary (3), Italy (3), Poland (3) and Australia (1).

What Was Measured

Researchers chose this as the main measure: Incidence of Treatment-emergent Serious Adverse Events (SAEs) (time frame: up to 108 Weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 84 people with multiple sclerosis.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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