NCT01067521

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

A Multinational, Multicenter, Randomized, Parallel-group Study Performed 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 in a Double-blind Design

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,404 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Detailed description

Participants who were randomized to the GA 40 mg treatment arm in the Double-Blind Period, continue that treatment in the Open-Label Extension Period and are referred to as "Early Start" participants. Participants randomized to the Placebo arm in the Double-Blind Period and switched to GA 40 mg subcutaneous injections three times a week in the Open-Label Extension are referred to as "Delayed Start" participants.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Glatiramer acetate (GA)	GA 40 mg/mL administered 3 times a week by subcutaneous injection for a period of 12 months for participants assigned to GA treatment in the Double-Blind Period, and GA 40 mg/mL administered 3 times a week by subcutaneous injection for all participants in the Open-Label Extension Period.
DRUG	Placebo	Placebo comparator administered by subcutaneous injection three times each week for 12 months during the Double-Blind Period.

Timeline

• Start date: 2010-06-22
• Primary completion: 2012-05-08
• Completion: 2017-05-12
• First posted: 2010-02-11
• Last updated: 2021-12-09
• Results posted: 2018-10-09

Locations

176 sites across 17 countries: United States, Bulgaria, Croatia, Czechia, Estonia, Georgia, Germany, Hungary, Israel, Italy, Lithuania, Poland, Romania, Russia, South Africa, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study