Safety profile of copolymer 1: analysis of cumulative experience in the United States and Israel

What Was Tested

This randomized controlled trial paper looks at Glatiramer Acetate.

The results of a phase III study, including previously unpublished information, are employed to delineate adverse events that occur more frequently among patients treated with copolymer 1 than in placebo-treated controls, and to provide qualitative information.

The most common adverse event was mild injection-site reaction, manifested by erythema, inflammation, and induration.

Who Took Part

The abstract describes 857 patients taking part.

This paper summarizes the worldwide cumulative experience with copolymer 1 (Copaxone) in 857 patients who were enrolled in open-label (n = 586), double-blind (n = 201), and compassioniate-use studies (n = 70).

How the Study Was Run

The researchers set it up as a randomized, double-blind, open-label and placebo-controlled study.

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

Neither the patients nor the staff measuring them knew who was on Glatiramer Acetate, so expectations could not easily colour the readings.

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.

A placebo (an inactive look-alike) gave the Glatiramer Acetate group a baseline to be compared against.

What Was Measured

The subject headings attached to it are Glatiramer Acetate, Immunosuppressive Agents, Israel, Peptides and United States.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Glatiramer Acetate in 857 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 1996 (Journal of neurology), a journal based in Germany.

More context: the Glatiramer Acetate compound page, all human trials.