Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness

What Was Tested

In this phase 4 trial, researchers set out to test Glatiramer Acetate for multiple sclerosis.

This open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (RRMS).

Participants have scheduled visits every 3 months to assess glatiramer acetate safety and their Multiple Sclerosis (MS) status.

It had two arms (groups): Glatiramer Acetate: Delayed Start (experimental) and Glatiramer Acetate: Early Start (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 208 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Participants must have participated (been randomized) in the Copaxone double-blind placebo-controlled study 01-9001 and/or the double-placebo-controlled extension study 01-9001E. Participants could be male or female. Women of childbearing potential must have practiced an acceptable method of birth control. Participants must have completed the scheduled termination visit for Amendment 12 (Month 264). Participants must have been psychologically and physically stable to participate in the trial as judged by the investigator.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: pregnancy or lactation; medical or psychiatric conditions that affect the participant's ability to give informed consent or complete the study; inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily.

How the Study Was Run

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

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 1994-03-26 with completion listed for 2018-02-28.

It ran at 11 sites in United States (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Adverse Events (AEs) (time frame: Baseline up to Month 288). Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288 (time frame: Baseline, Month 288).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Glatiramer Acetate in 208 people with multiple sclerosis.

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.