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AN IMMUNOMODULATOR WITH DEMONSTRATED EFFICACY1

COPAXONE® (glatiramer acetate injection) has a clinical profile demonstrated across 5 clinical trials.1 Select 1 of the 5 trials to view study data, or scroll down.

Khan 2013 GALA

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.1,2

Baseline Patient Characteristics2
Prestudy number of relapses, mean over 1 year (±SD)

Placebo (n=461)

1.3 (0.6)

COPAXONE® 40 mg/mL (n=943)

1.3 (0.6)

T2 lesion volume, mean (±SD)

Placebo (n=461)

17.4 mL (17.4)

COPAXONE® 40 mg/mL (n=943)

19.7 mL (20.7)

Number of T1-enhancing lesions, mean (±SD)

Placebo (n=461)

1.4 (3.7)

COPAXONE® 40 mg/mL (n=943)

1.7 (4.7)

3-times-a-week COPAXONE® 40 mg/mL significantly reduced relapses at 1 year.1,2

Clinical study results for COPAXONE® treatments of 40mg/mL 3-times-a-week.

3-times-a-week COPAXONE® 40 mg/mL significantly reduced T1 lesions at 1 year.2

Clinical study results for COPAXONE® treatments of 40mg/mL 3-times-a-week.

3-times-a-week COPAXONE® 40 mg/mL significantly reduced the number of new or enlarging T2 lesions at 1 year.2

Clinical study results for COPAXONE® treatments of 40mg/mL 3-times-a-week.

Comi 2009 PreCISe

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.1,3

Baseline Patient Characteristics3
Number of GdE lesions per patient, mean (±SD)

Placebo (n=238)

1.6 (2.9)

COPAXONE® 20 mg/mL (n=243)

1.3 (2.8)

Number of T2 lesions, mean (±SD)

Placebo (n=238)

29.9 (26.3)

COPAXONE® 20 mg/mL (n=243)

33.0 (34.4)

In CIS, COPAXONE® significantly delayed time to second clinical event by more than a year (386 days).3

Clinical study results for COPAXONE® 20mg/mL daily treatments.

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).1

In CIS, COPAXONE® significantly reduced new T2 lesions.3

Clinical study results for COPAXONE® 20mg/mL daily treatments.

Comi 2001

A 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.1,4

Baseline Patient Characteristics4
Number of GdE lesions per patient, mean (±SD)

Placebo (n=120)

4.4 (7.1)

COPAXONE® 20 mg/mL (n=119)

4.2 (4.8)

T2 lesion volume (mL), mean (±SD)

Placebo (n=120)

20.5 (18.8)

COPAXONE® 20 mg/mL (n=119)

20.0 (17.2)

In RRMS, COPAXONE® significantly reduced disease activity as measured by T1 GdE lesions.4

Clinical study results for COPAXONE® 20mg/mL treatments.

Johnson 1995

Double-blind, randomized, placebo-controlled, multicenter trial of glatiramer acetate in patients with RRMS (N=251; 125 COPAXONE®, 126 placebo).1,5

Baseline Patient Characteristics5
Duration of disease, mean years (±SD)

Placebo (n=126)

6.6 (5.1)

COPAXONE® 20 mg/mL (n=125)

7.3 (4.9)

EDSS score, mean (±SD)

Placebo (n=126)

2.4 (1.3)

COPAXONE® 20 mg/mL (n=125)

2.8 (1.2)

Prior exacerbation rate, mean over 2 years (±SD)

Placebo (n=126)

2.9 (1.1)

COPAXONE® 20 mg/mL (n=125)

2.9 (1.3)

In RRMS, COPAXONE® reduced relapses.1,5

 Clinical study results for COPAXONE® 20mg/mL treatments.

Bornstein 1987

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).1,6

Baseline Patient Characteristics6
Duration of disease, average years*

Placebo (n=25)

6.1

COPAXONE® 20 mg/mL (n=25)

4.9

DSS score, average

Placebo (n=25)

3.2

COPAXONE® 20 mg/mL (n=25)

2.9

Prior exacerbation rate, average over 2 years*

Placebo (n=25)

3.9

COPAXONE® 20 mg/mL (n=25)

3.9

In RRMS, COPAXONE® significantly reduced relapses.6

Primary endpoint: 56% of COPAXONE® patients were free of relapse at 2 years vs 28% of placebo patients (P=0.085).1

Clinical study results for COPAXONE® 20mg/mL treatments.

Review safety data for COPAXONE®.

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Click on a link or scroll down to see the studies.

References:

1. COPAXONE® (glatiramer acetate injection) Current Prescribing Information Parsippany, NJ. Teva Neuroscience, Inc.

2. Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R; for the GALA Study Group. Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis. Ann Neurol. 2013;73(6):705-713. doi:10.1002/ana.23938

3. Comi G, Martinelli V, Rodegher M, et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Lancet. 2009;374(9700):1503-1511. doi:10.1016/S0140-6736(09)61259-9

4. Comi G, Filippi M, Wolinsky JS; and the European/Canadian Glatiramer Acetate Study Group. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging–measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol. 2001;49(3):290-297. https://doi.org/10.1002/ana.64

5. Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology. 1995;45(7):1268-1276. doi:10.1212/wnl.45.7.1268

6. Bornstein MB, Miller A, Slagle S, et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N Engl J Med. 1987;317(7):408-414. doi:10.1056/NEJM198708133170703

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.

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