A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection [amount hidden] Administered Three Times a Week Compared to Placebo

What Was Tested

In this phase 3 trial, researchers set out to test Glatiramer Acetate for multiple sclerosis.

It had two arms (groups): one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1404 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: Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria with a relapsing-remitting disease course. Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits. Subjects must have experienced one of the following:. Subjects must be between 18 and 55 years of age, inclusive. Women of child-bearing potential must practice an acceptable method of birth control.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: subjects with progressive forms of ms; use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening; use of immunosuppressive (including mitoxantrone and fingolimod) or cytotoxic agents within 6 months prior to the screening visit.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-06-22 with completion listed for 2012-05-08.

It ran at 176 sites in United States (37), Bulgaria (20), Poland (18), Russia (17), Germany (15) and Ukraine (15).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression (time frame: Day 1 to 12 months). Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression (time frame: Day 1 up to 6.5 years).

It also tracked 7 secondary outcomes, for example The Number of New/Enlarging T2 Lesions at Months 6, 12 and 36 Estimated by Negative Binomial Regression and Participants With Treatment-Emergent Adverse Events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 1404 people with multiple sclerosis.

With 1404 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.