Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

What Was Tested

This registered phase 3 trial tested Glatiramer Acetate for multiple sclerosis.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS.

It had four arms (groups): one (experimental), one (experimental), Placebo (placebo comparator) and one (active comparator).

Participants received two placebo capsules orally three times daily (TID).

The registry classes the interventions as drug.

More on the Plan

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe.

It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Who Took Part

1417 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: Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4. Must have a baseline EDSS between 0.0 and 5.0, inclusive. Must have relapsing-remitting disease course.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease; pregnant or nursing women.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

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 2007-06 with completion listed for 2011-08.

It ran at 195 sites in United States (72), Germany (17), India (14), Mexico (9), Poland (9) and Spain (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Annualized Relapse Rate (time frame: 2 years).

It also tracked 4 secondary outcomes, for example Number of New or Newly Enlarging T2 Hyperintense Lesions, Number of New T1 Hypointense Lesions, Proportion of Subjects Relapsed and Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 1417 people with multiple sclerosis.

With 1417 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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