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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
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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

Indication

COPAXONE® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

 

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 patients exposed to COPAXONE® 40 mg per mL compared to none on placebo experienced a constellation of symptoms immediately after injection that included at least 2 of the following: flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and urticaria. In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.

Transient chest pain was noted in 13% of COPAXONE® 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of COPAXONE® 40 mg per mL patients compared to 1% on placebo. While some episodes of chest pain occurred in the context of the immediate postinjection reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.

At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.

Because COPAXONE® can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE® may interfere with recognition of foreign antigens in a way that would undermine the body's tumor surveillance and its defenses against infection. There is no evidence that COPAXONE® does this, but there has not been a systematic evaluation of this risk.

In controlled studies of COPAXONE® 20 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%).

In a controlled study of COPAXONE® 40 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were ISRs, such as erythema (22% vs 2%).

ISRs were one of the most common adverse reactions leading to discontinuation of COPAXONE®. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with COPAXONE® than placebo.

Please see full Prescribing Information for COPAXONE®.

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

Indication

COPAXONE® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

 

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 patients exposed to COPAXONE® 40 mg per mL compared to none on placebo experienced a constellation of symptoms immediately after injection that included at least 2 of the following: flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and urticaria. In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.

Transient chest pain was noted in 13% of COPAXONE® 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of COPAXONE® 40 mg per mL patients compared to 1% on placebo. While some episodes of chest pain occurred in the context of the immediate postinjection reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.

At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.

Because COPAXONE® can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE® may interfere with recognition of foreign antigens in a way that would undermine the body's tumor surveillance and its defenses against infection. There is no evidence that COPAXONE® does this, but there has not been a systematic evaluation of this risk.

In controlled studies of COPAXONE® 20 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%).

In a controlled study of COPAXONE® 40 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were ISRs, such as erythema (22% vs 2%).

ISRs were one of the most common adverse reactions leading to discontinuation of COPAXONE®. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with COPAXONE® than placebo.

Please see full Prescribing Information for COPAXONE®.

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