A 12-month, double-blind, placebo-controlled, multinational study. Patients with RRMS were randomized to receive 3-times-a-week COPAXONE® 40 mg/mL (n=943) or placebo (n=461). The primary endpoint was total number of confirmed relapses.1,6
A 3-year, multicountry, multicenter, randomized, placebo-controlled, double-blind study in which 481 subjects with clinically isolated syndrome (CIS) were equally randomized into 2 parallel treatment groups: COPAXONE® 20 mg/mL (n=243) or matching placebo (n=238) administered once daily as a subcutaneous (SC) injection. The primary endpoint of the intent-to-treat analysis was time to conversion to clinically definite MS.1,2
Secondary endpoint: 42.4% reduction in patients experiencing a second clinical event within 36 months among patients taking COPAXONE® compared to those taking placebo (24.7%, n=243 vs 42.9%, n=238, respectively; P<0.0001).
Double-blind, placebo-controlled study to determine the effect of COPAXONE® on the cumulative number of enhancing lesions found on monthly MRI in patients with RRMS (N=239; 119 COPAXONE®, 120 placebo) for 9 months. The primary outcome measure was the total number of enhancing lesions on T1-weighted images.1,3
Double-blind, randomized, placebo-controlled, multicenter trial of glatiramer acetate in patients with RRMS (N=251; 125 COPAXONE®, 126 placebo).1,5
A 2-year, single-center, randomized study in which 50 subjects received daily doses of either COPAXONE® 20 mg/mL SC or placebo (COPAXONE®: n=25; placebo: n=25).1,4
Primary endpoint: 56% of COPAXONE® patients were free of relapse at 2 years vs 28% of placebo patients (P=0.085)1
CI, confidence interval; CIS, clinically isolated syndrome; DSS, Disability Status Scale; EDSS, Expanded Disability Status Scale; GdE, gadolinium-enhancing; LOV, last observed value; RRMS, relapsing-remitting multiple sclerosis; SD, standard deviation.
*Average reported without SD in study.
†Kurtzke DSS utilized in study; average reported without SD.
Injections for 3-times-a-week COPAXONE® 40 mg must be at least 48 hours apart.
COPAXONE® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE® 20 mg per mL compared to 4% of those on placebo, and approximately 2% of
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