A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo

Summary

The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled period. The study has two periods: * Placebo Controlled Period: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo. * Open Label Extension Period: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor

Timeline

Start

2010-06-22

Primary completion

2012-05-08

Completion

2017-05-12

Outcome

Met primary endpoint

registry Early Start: GA 40 mg / GA 40 mg vs Delayed Start: Placebo / GA 40 mg; p <0.0001 NCT01067521 ↗

registry Early Start: GA 40 mg / GA 40 mg vs Delayed Start: Placebo / GA 40 mg; p = 0.0409 NCT01067521 ↗

release “The GALA study evaluating glatiramer acetate 40 mg/1 ml administered three times weekly met primary endpoint” tevapharm.com ↗

release “glatiramer acetate (GA) 40mg/ 1 mL injections administered three times a week reduced annualized relapse rates by 34.0% (p<0.0001)” tevapharm.com ↗

release “a 40 mg/mL dose of COPAXONE® administered subcutaneously three-times-a-week significantly reduced relapse rates at 12 months” tevapharm.com ↗

release “GALA study, which included more than 1,400 patients, the 40 mg/ml dosage of COPAXONE® administered subcutaneously three times per week significantly reduced relapse rates” tevapharm.com ↗

Publications

• Khan O, Rieckmann P, Boyko A, Selmaj K, Ashtamker N, Davis MD, Kolodny S, Zivadinov R. Efficacy and safety of a three-times-weekly dosing regimen of glatiramer acetate in relapsing-remitting multiple sclerosis patients: 3-year results of the Glatiramer Acetate Low-Frequency Administration open-label extension study. Mult Scler. 2017 May;23(6):818-829. doi: 10.1177/1352458516664033. Epub 2016 Aug 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glatiramer Acetate	Small molecule	40 mg	Subcutaneous

Indications