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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
794
Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)
Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
The Number of T1-Gadolinium Enhancing Lesions During Months 7-9
The primary endpoint was the total number of gadolinium enhancing lesions (i.e., the cumulative number of new and persisting gadolinium enhancing lesions) during months 7 through 9.
Time frame: 9 months
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Synthon investigational site 112
Irvine, California, United States
Synthon investigational site 120
Port Charlotte, Florida, United States
Synthon investigational site 130
Sunrise, Florida, United States
Synthon investigational site 107
Elk Grove Village, Illinois, United States
Synthon investigational site 141
Raleigh, North Carolina, United States
Synthon investigational site 106
Cleveland, Ohio, United States
Synthon investigational site 135
Dayton, Ohio, United States
Synthon investigational site 401
Bitebsk, Belarus
Synthon investigational site 403
Grodno, Belarus
Synthon investigational site 402
Homyel, Belarus
...and 123 more locations