An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) [amount hidden] New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

What Was Tested

The trial (phase 3) is built around Glatiramer Acetate for multiple sclerosis.

It had two arms (groups): Glatiramer Acetate (experimental) and Placebo (placebo comparator).

Placebo solution in prefilled syringe for subcutaneous injection once daily.

The registry classes the interventions as drug.

More on the Plan

Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.

Who Took Part

The registry lists 178 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 multiple sclerosis (MS) diagnosis as defined by the 2010 Revised McDonald criteria \[Ann Neurol 2011: 69:292-302\], with a relapsing-remitting disease course. Subjects must be ambulatory with a Kurtzke's Expanded Disability Status Scale (EDSS) score of 0-5.5 in both screening and baseline visits. Subjects must have experienced one of the following:. At least one documented relapse in the 12 months prior to screening,. At least two documented relapses in the 24 months prior to screening,.

The full record lists 11 inclusion and 17 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 agents (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 double-blind study.

Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2012-03 with completion listed for 2012-10.

It ran at 169 sites in United States (25), Bulgaria (23), Russia (23), Poland (19), Ukraine (14) and Romania (12).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The Annualized Relapse Rate During the Placebo Controlled Period (time frame: Day 1 up to Month 12).

It also tracked 3 secondary outcomes, for example The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period), The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period) and Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 178 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.