Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients

What Was Tested

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

This is an open-label, multicenter study conducted at approximately 20 sites.

Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.

It had 1 arm (groups): one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patient satisfaction will be evaluated using an Experience Questionnaire throughout the study.

Who Took Part

148 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: Patients ≥ 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS). Willing and able to complete all procedures and evaluations related to the study. Willing to continue to follow usual injection site preparation and routine adjunctive local injection site reactions (LISR) management techniques. Willing and able to provide written informed consent.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: currently using or treated with another immunomodulating therapy (imt) in conjunction with ga in the 30 days prior to screening for this study; currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study; pregnant or planning pregnancy or breastfeeding.

How the Study Was Run

Design: non-randomized, single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-07 with completion listed for 2010-11.

What Was Measured

The main thing measured (primary outcome): Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience.

It also tracked 1 secondary outcome, for example Patient Injection Experience Preference.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Glatiramer Acetate in 148 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.