Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate

What Was Tested

This registered phase 4 trial tested Glatiramer Acetate for multiple sclerosis.

This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.

It had two arms (groups): GA + Placebo (active comparator) and GA + Prednisone (experimental).

The registry classes the interventions as drug.

More on the Plan

The reasons why the need for futility arose were: 1.

Who Took Part

414 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clinically definite multiple sclerosis (CDMS) according to Poser (Ann. Neurol. 1983) or McDonald (Ann. Neurol. 2001). Subjects eligible for GA treatment based on the investigator's clinical assessment and according to the current indication. Subjects must have a relapsing remitting disease course. Subjects must have had at least 1 documented relapse within the last year prior to study entry. Subjects must be between the ages of 18 and 55 years inclusive.

The full record lists 8 inclusion and 20 exclusion criteria; among the exclusions: previous use of cladribine; previous use of mitoxantrone; use of digitalis at study entry.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

Blinding on both sides kept the multiple sclerosis participants and researchers unaware of who received Glatiramer Acetate.

Those kept unaware of assignments: participant and investigator.

It started in 2005-01 with completion listed for 2009-05.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method (time frame: Day 0, latest scan at month 24, 36 or early termination visit).

It also tracked 3 secondary outcomes, for example Cumulative Number of Enhancing Lesions at Months 12, 24 and 36, Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions and Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 414 people with multiple sclerosis.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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