Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Copolymer 1 Multiple Sclerosis Study Group

What Was Tested

This randomized controlled trial paper looks at Glatiramer Acetate in the context of multiple sclerosis.

Of the original 251 patients randomized to receive glatiramer acetate or placebo, 208 chose to continue in an open-label study with all patients receiving active drug.

The majority of the original double-blind cohort continues to receive glatiramer acetate by daily subcutaneous injection and are evaluated at 6-month intervals and during suspected relapse.

Who Took Part

According to the abstract, 251 patients were involved.

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

How the Study Was Run

In design terms this was 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.

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

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.

The methods mention a period of 35 months.

What Was Measured

The majority of the original double-blind cohort continues to receive glatiramer acetate by daily subcutaneous injection and are evaluated at 6-month intervals and during suspected relapse.

The data reported here are from approximately 6 years of organized evaluation, including the double-blind phase of up to 35 months and the open-label phase of over 36 months.

PubMed files the paper under topics including Adjuvants, Immunologic, Cohort Studies, Persons with Disabilities, Glatiramer Acetate, Multiple Sclerosis, Relapsing-Remitting, Nervous System and Patient Dropouts.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Glatiramer Acetate in 251 patients in people with multiple sclerosis over 35 months.

The publication is from 2000 (Multiple sclerosis (Houndmills, Basingstoke, England)), a journal based in England.

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