Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis

What Was Tested

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

Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to March 23, 2016.

Number of patients, involved into the study of the medicinal product for medical use: 158 patients.

It had three arms (groups): BCD-063 (glatiramer acetate) (experimental), one (active comparator) and Placebo (placebo comparator).

Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day.

The registry classes the interventions as drug.

Who Took Part

158 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: Previously diagnosed multiple sclerosis (MS, McDonald criteria 2005);. Disease more, than 1 year prior to inclusion;. Presence of 1 relapse previously OR at least 1 Gd+ lesion in T1 regimen;. Absence of exacerbations for 4 weeks prior to inclusion;. Readiness of patients (both genders) to use reliable methods of contraception (at least 1 barrier method in combination with: spermicides, intrauterine device/oral contraceptives).

The full record lists 6 inclusion and 21 exclusion criteria; among the exclusions: secondary progressive and primary progressive forms of multiple sclerosis;; any acute or chronic infection in the acute stage;; verified hiv, hepatitis b and c, syphilis;.

How the Study Was Run

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

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.

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

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

It started in 2013-10 with completion listed for 2015-11.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Cumulative Unique Activity lesions (time frame: 48 weeks).

It also tracked 12 secondary outcomes, for example Annual relapse rate, Proportion of patients without relapses, Changing in volume of hypointense T1 lesions, Changing in volume of T2 lesions, Amount of new or extended lesions in T2 regimen and Patients proportion without lesions.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 158 people with multiple sclerosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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