Safety and Tolerability of Glatiramer Acetate

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

The study will comprise of a Core study and an Extension phase.

During the Core study, subjects will be evaluated at study sites for 5 scheduled visits at Months: -1 (Screening), 0 (Baseline), 1, 2, and 4 (Termination/Early Termination).

Subjects who complete all scheduled visits will have final procedures and assessments performed at the final visit (Month 4, Termination visit).

Subjects who withdraw from the study before completing the 4 months evaluation period will have Early Termination (ET) procedures and assessments performed at their final visit.

Who Took Part

Enrollment: 209 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: Men or women at least 18 years of age or older. Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course. Subjects must be ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5.5 in both the Screening and Baseline visits. Subjects must be able to sign and date a written informed consent prior to entering the study. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: subject has any contraindication to glatiramer acetate therapy; subjects with progressive forms of multiple sclerosis (ms); subjects with neuromyelitis optica (nmo).

How the Study Was Run

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

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

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

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

It started in 2013-06 with completion listed for 2014-04.

It ran at 35 sites in United States (35).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period (time frame: Day 1 to Month 4). Injection-Related Adverse Event Rate Per Year in the Extension Period (time frame: Month 5 up to Month 10). Injection-Related Adverse Events in the Extension Period (time frame: Month 5 up to Month 10).

It also tracked 11 secondary outcomes, for example Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period, Injection Site Reaction Event Rate Per Year in the Extension Period and Injection Site Reaction Events in the Extension Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 209 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.