← Human Trials & Peer-Reviewed Studies

Comparison of glatiramer acetate (Copaxone) and interferon beta-1b (Betaferon) in multiple sclerosis patients: an open-label 2-year follow-up

Plain-language guide to PMID 11997066 (2002): open-label and parallel-group clinical trial study of Glatiramer Acetate in 58 patients, multiple sclerosis.

Key Facts

PMID
11997066
Journal
Journal of the neurological sciences
Year
2002
Study type
Clinical Trial
Authors
Flechter S et al. (4 authors)
DOI
10.1016/s0022-510x(02)00047-3

What This Study Did, in Plain Language

What Was Tested

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

Copaxone and IFN beta - 1b have been recently introduced for the treatment of relapsing forms of MS.

Who Took Part

The abstract describes 58 patients taking part.

58 consecutive patients with relapsing forms of MS were enrolled from the MS out-patient clinic, during three months.

Mean relapse rate/year and mean EDSS/year were calculated for each group of patients during the 2 years prior to the onset of treatment, and during the year prior to the onset of treatment.

How the Study Was Run

The design is described as open-label and parallel-group.

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.

Groups ran in parallel: each of the patients stayed in one arm throughout.

A time span of three months appears in the methods.

This statistical difference has no effect on the overall data of the 2 years prior to starting the treatment and on the results.

Mean relapse rate/year and mean EDSS/year were calculated for each group during the first and second year of treatment.

Wilcoxon analysis for clinical data and chi-square for adverse events were applied.

What Was Measured

The subject headings attached to it are Adjuvants, Immunologic, Disability Evaluation, Glatiramer Acetate, Interferon-beta, Multiple Sclerosis, Relapsing-Remitting, Patient Dropouts and Peptides.

What This Means in Plain Language

The paper is an open-label and parallel-group study of Glatiramer Acetate in 58 patients in people with multiple sclerosis over three months.

Results are reported in around 8 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2002 (Journal of the neurological sciences), a journal based in Netherlands.

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

Our Notes on the Compound

Glatiramer Acetate: A mix of synthetic amino-acid chains (Copaxone) used in relapsing multiple sclerosis.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.