Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, glatiramer acetate, MRI, lesions, MS relapse rate, Copaxone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 794
Healthy volunteers: no

Brief summary:
The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis

Detailed description:
GTR is being developed by Synthon as a similar version of Copaxone®. GTR has a similar quantitative and qualitative composition as Copaxone®, with regard to active substance and excipients and is presented in the same dosage form (pre-filled syringe containing a solution for injection). Introduction of GTR is anticipated to have a price lowering effect and will give doctors and patients more choice in the pharmaceutical armamentarium for MS.

This trial consists of two parts:

Part 1 is a multi-country, multi-centre, randomized, double-blind, active and placebo-controlled, equivalence trial comparing the efficacy and safety and tolerability of GTR versus Copaxone® in subjects with RRMS. Eligible subjects will be randomly assigned to receive daily 20 mg GTR (Synthon BV), 20 mg Copaxone® (TEVA) or placebo for a period of 9 months.

In Part 2, the trial continues as an open-label uncontrolled trial to evaluate efficacy and safety of long-term treatment with GTR. Subjects completing the 9-month double-blind period will be treated with open-label 20 mg daily GTR for another 15 months.

Arms:
arm 1: Drug arm 2: Drug arm 3: Drug

Interventions: intervention 1: Glatiramer Acetate (GTR) intervention 2: Glatiramer Acetate (Copaxone®) intervention 3: Placebo
Intervention descriptions: intervention 1: Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2) intervention 2: Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2) intervention 3: Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

Protocol document: