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Copaxone® is the #1 prescribed brand for relapsing MS in the US 1*

An immunomodulator with demonstrated efficacy, safety, and tolerability1

Trust in a rigorously tested clinical profile proven across 5 clinical studies.1

Select one of the 5 key trials to view complete data. Or scroll down to see trial summaries.


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.1,6

Baseline Patient Characteristics6
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 year1,6

Annualized relapse rate (ARR)1,6

0.505
0.331
34%
P<0.0001

3-times-a-week COPAXONE® 40 mg/mL significantly reduced T1 lesions at 1 year6

Cumulative number of enhancing T1 lesions at 6 and 12 months1,6

1.639
0.905
45%
P<0.0001

3-times-a-week COPAXONE® 40 mg/mL significantly reduced T2 lesions at 1 year6

Cumulative number of new or enlarging T2 lesions at 6 and 12 months1,6

5.592
3.650
35%
P<0.0001

3-times-a-week COPAXONE® 40 mg/mL — Proven in the largest COPAXONE® pivotal trial to date1,6

  • 12-month, global, multicenter, placebo-controlled trial (N=1404)
  • The first COPAXONE® pivotal trial conducted utilizing revised 2005 McDonald criteria
  • 91% of patients completed the randomized phase
  • Aged 18-55 years
  • RRMS (revised 2005 McDonald criteria)
  • EDSS score of ≤5.5
  • Relapse free ≥30 days
3-times-a-week placebo
(n=461)
3-times-a-week COPAXONE®
40 mg/mL (n=943)
Screening
Randomization (2:1)
12
9
6
3
0
-1
MRI, safety evaluation
MRI, safety evaluation
MRI, safety evaluation
Safety
evaluation
Clinical endpoint1,6:
Total number of confirmed relapses (primary endpoint)
MRI endpoints1,6:
Cumulative number of new/enlarging T2 lesions at 6 and 12 months
Cumulative number of Gd-enhancing T1 lesions at 6 and 12 months

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.1,2

Baseline Patient Characteristics2
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)2

Primary endpoint: Time to second clinical event1,2

45%RELATIVE RISK
REDUCTION

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).

In CIS — COPAXONE® significantly reduced new T2 lesions2

Secondary endpoint: Number of new T2 lesions at LOV1,2

1.8
0.7
59%
P<0.0001

Comi 2001

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

Baseline Patient Characteristics3
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, mean (±SD)
Placebo (n=120)
20.5 mL (18.8)
COPAXONE® 20 mg/mL (n=119)
20.0 mL (17.2)

In RRMS — COPAXONE® significantly reduced disease activity as measured by T1 GdE lesions3

Gadolinium-enhancing (GdE) lesions (9 months)1,3

17
11
35%
P=0.0030

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 Characteristics3
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 relapses5

Primary endpoint: Mean relapse frequency over 2 years5

1.68
1.19
29%
P=0.055

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).1,4

Baseline Patient Characteristics4
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 relapses4

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

Secondary endpoint: Mean relapse frequency over 2 years1,4

2.4
0.6
75%
P=0.005
Discover how COPAXONE® is thought to work
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Click on a link or scroll down to see the studies.

Khan 2013 GALA Comi 2009 PreCISe Comi 2001 Johnson 1995 Bornstein 1987

References

  1. COPAXONE® (glatiramer acetate injection) prescribing information. Rev. 8/2016. Teva Neuroscience, Inc.
  2. Comi G, Martinelli V, Rodegher M, et al; for the PreCISe study group. Lancet. 2009;374(9700):1503-1511.
  3. Comi G, Filippi M, Wolinsky JS. Ann Neurol. 2001;49(3):290-297.
  4. Bornstein MB, Miller A, Slagle S, et al. N Engl J Med. 1987;317(7):408-414.
  5. Johnson KP, Brooks BR, Cohen JA, et al. Neurology. 1995;45(7):1268-1276.
  6. Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R; for the GALA Study Group. Ann Neurol. 2013;73(6):705-713.

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.

IMPORTANT SAFETY INFORMATION

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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