Continuous long-term immunomodulatory therapy in relapsing multiple sclerosis: results from the 15-year analysis of the US prospective open-label study of glatiramer acetate

What Was Tested

The paper reports a study of Glatiramer Acetate in the context of multiple sclerosis, published as a randomized controlled trial.

The objective of this study was to evaluate up to 15 years of GA as a sole disease-modifying therapy.

Why It Was Studied

The ongoing US Glatiramer Acetate (GA) Trial is the longest evaluation of continuous immunomodulatory therapy in relapsing-remitting multiple sclerosis (RRMS).

Mean GA exposures were 8.6 +/- 5.2, 4.81 +/- 3.69, and 13.6 +/- 1.3 years and mean disease durations were 17, 13, and 22 years for mITT, Withdrawn and Ongoing cohorts, respectively.

Who Took Part

PubMed indexes the participants as adults, both men and women.

Patients were evaluated every 6 months using the Expanded Disability Status Scale (EDSS).

How the Study Was Run

The design is described as randomized, double-blind and crossover.

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

As a double-blind Glatiramer Acetate study, the assignments were hidden from both participants and investigators until the end.

In the crossover set-up each of the participants took both Glatiramer Acetate and the comparison in turn, acting as their own control.

What Was Measured

The ongoing US Glatiramer Acetate (GA) Trial is the longest evaluation of continuous immunomodulatory therapy in relapsing-remitting multiple sclerosis (RRMS).

Topics PubMed links to this paper include Chi-Square Distribution, Disability Evaluation, Glatiramer Acetate, Immunologic Factors, Kaplan-Meier Estimate, Logistic Models and Multiple Sclerosis, Relapsing-Remitting.

What This Means in Plain Language

The paper is a randomized, double-blind and crossover study of Glatiramer Acetate in people with multiple sclerosis.

The publication is from 2010 (Multiple sclerosis (Houndmills, Basingstoke, England)), a journal based in England.

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