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Label indication COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults… FDA label
Also known as Glatiramer Acetate, Glatiramer Acetate (DB), Glatiramer acetate (GA), Copaxone, F1
glatiramer · 11 trials · 6 indications
The Satisfaction with Injection Experience questionnaire consists of 5 questions where participants are asked to rate their injection experience over the past 2 weeks on ease of use, bother, acceptability, confidence to inject and satisfaction. The response options range from "strongly disagree" (score = 1) to "strongly agree" (score = 5). The composite score of Satisfaction with Injection Experience is defined as the mean of the five Likert questions. The composite score ranges from 1.0 to 5.0, with a score of 5.0 representing the most satisfaction with injection experience and a score of 1.0 representing the least satisfaction with injection experience.
Relapses were monitored throughout the study. During the PC Period, two neurologists/physicians assessed subjects' general medical and neurological evaluations separately. A relapse was defined as the appearance of 1+ new neurological abnormalities or the reappearance of 1+ previously observed neurological abnormalities lasting \>= 48 hours and immediately preceded by an improving neurological state of at \>=30 days from onset of previous relapse. An event was counted as a relapse only when the subject's symptoms were accompanied by observed objective neurological changes, consistent with \>= one of the following: - An increase of \>= 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation. - An increase of one grade in the actual score of \>=2 of the 7 functional systems (FS), as compared to previous evaluation. - An increase of 2 grades in the actual score of one FS as compared to the previous evaluation. Adjusted mean values are displayed.
The annualized relapse rate (ARR) was calculated for the study by dividing the cumulative number of confirmed relapses by the number of person-years of exposure to treatment. The analysis of the annualized relapse rate is based on estimating a contrast (early start vs delayed start) derived from a baseline-adjusted, Negative Binomial Regression model to the number of confirmed relapses observed during study (post randomization) with an "offset" based on the log of exposure to treatment.
A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent "no pain" and up to 100 mm to represent "worst possible pain;" subjects drew a continuous line to represent their level of pain.
Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.
A confirmed relapse is defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities. This change in clinical state must last at least 48 hours and be immediately preceded by an improving neurological state of at least thirty (30) days from onset of previous relapse.
Data from interim analysis with database lock on October 14, 2007. The time from randomization to conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).
Data from interim analysis with database lock on October 14, 2007. Due to the number of participants in the glatiramer acetate group that converted to CDMS (see outcome #6), the 25th percentile was considered when running the Kaplan-Meier estimate for time to conversion to CDMS. Conversion to CDMS is determined by the occurrence of the second clinical attack.
The ALSFRS-R is a questionnaire-based scale for monitoring the progression of disability in patients with ALS. It is composed of 12 items, each scored between 0 and 4.The total score, calculated as the sum of these 12 items, ranges from 0 to 48. The higher the score, the less disabled the participant. Timepoints after baseline were included in calculation of slope of change in ALSFRS-R. Slope is derived from the time by treatment interaction term from the Repeated Measures Analysis of Covariance model. Descriptive statistics of the slope are reported.
Change in the sum of T1 Gd-enhancing lesions measured at pre-treatment (weeks -10 \[screening\], -6 and 0 \[baseline\]) to the sum of T1 Gd-enhancing lesions measured in the last study trimester (weeks 28, 32 and 36 \[termination\]).
| Arm | Type | Description |
|---|---|---|
| 20 mg/0.5 mL Glatiramer Acetate | ACTIVE_COMPARATOR | Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2). |
| GA 40 mg / GA 40 mg | EXPERIMENTAL | Also referred to as the 'Early Start' treatment arm, participants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the Double-Blind Period, and then continued that treatment as open-label therapy until the drug was commercially available or development stopped. |
| Placebo / GA 40 mg | PLACEBO_COMPARATOR | Also referred to as the 'Delayed Start' treatment arm, participants were administered placebo subcutaneous injections three times a week for 12 months during the Double-Blind Period, and then switched to GA 40 mg/mL subcutaneous injections three times a week as open-label therapy until the drug was commercially available or development stopped. |
| F1 Glatiramer acetate 20mg/1.0ml | ACTIVE_COMPARATOR | - |
| F2 Glatiramer acetate 20mg/0.5ml | EXPERIMENTAL | - |
| Glatiramer acetate | EXPERIMENTAL | Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo subcutaneous injection once a day for up to 6 months. |
| glatiramer acetate 40 mg | ACTIVE_COMPARATOR | - |
| glatiramer acetate 20 mg | ACTIVE_COMPARATOR | - |
| Placebo (DB) to GA (OL) | PLACEBO_COMPARATOR | Placebo matching glatiramer acetate once daily by subcutaneous injection during the double-blind period (DB). Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection during the open-label period (OL). |
| 40 mg glatiramer acetate (GA) | EXPERIMENTAL | Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day. |
| Glatiramer Acetate, N-Acetylcysteine | ACTIVE_COMPARATOR | - |
| Glatiramer Acetate injection with oral minocycline | ACTIVE_COMPARATOR | Glatiramer Acetate 20mg with oral minocycline 100mg |
| Glatiramer Acetate with placebo | EXPERIMENTAL | Glatiramer acetate injection 20mg with oral placebo |
| Copaxone 20 mg | ACTIVE_COMPARATOR | Copaxone 20 mg |
| Copaxone 20mg with Novantrone induction | ACTIVE_COMPARATOR | Copaxone 20mg with Novantrone induction |
| Name | Type | Description |
|---|---|---|
| Glatiramer Acetate 20 mg/0.5 mL | DRUG | 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe. |
| Glatiramer acetate (GA) | DRUG | GA 40 mg/mL administered 3 times a week by subcutaneous injection for a period of 12 months for participants assigned to GA treatment in the Double-Blind Period, and GA 40 mg/mL administered 3 times a week by subcutaneous injection for all participants in the Open-Label Extension Period. |
| Placebo | DRUG | Placebo comparator administered by subcutaneous injection three times each week for 12 months during the Double-Blind Period. |
| Glatiramer Acetate | DRUG | Subjects received both doses once daily in a crossover fashion, for a total treatment duration of five weeks, including a one-week run-in period. Subject-reported injection pain was recorded in a daily diary. |
| Experimental Glatiramer Acetate | DRUG | GA 20 mg/0.5 mL |
| Glatiramer Acetate (GA) 40 mg | DRUG | Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months |
| glatiramer acetate 20 mg | DRUG | Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months |
| Glatiramer Acetate (DB) | DRUG | Double blind period (DB): glatiramer acetate (GA) by subcutaneous injection, 20mg, once daily, for up to 36 months or until conversion to clinically definite multiple sclerosis (CDMS). |
| Glatiramer Acetate (OL) | DRUG | Open label period (OL): glatiramer acetate (GA), 20 mg, subcutaneous injection, once daily, given for up to an additional 24 months. |
| 40 mg glatiramer acetate | DRUG | parenteral drug |
| Glatiramer Acetate, N-Acetylcysteine | DRUG | Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses. |
| glatiramer acetate with minocycline | DRUG | Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg |
| Glatiramer acetate with placebo | DRUG | Subcutaneous injection glatiramer acetate 20mg, with oral placebo |
| glatiramer acetate 40 mg | DRUG | glatiramer acetate 40 mg |
| glatiramer acetate 20 mg, with mitoxantrone | DRUG | glatiramer acetate 20 mg, with mitoxantrone |
Inclusion Criteria: * Patients ≥ 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) * Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject 2 for glass syring...
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Glatiramer is studied for neurologic conditions including relapsing remitting multiple sclerosis, optic neuritis, and amyotrophic lateral sclerosis. Its clinical trial program has focused mainly on relapsing forms of multiple sclerosis, with completed studies in relapsing remitting multiple sclerosis and a first episode of acute optic neuritis.
Glatiramer is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor behind the clinical trial program evaluating glatiramer in neurologic conditions such as relapsing remitting multiple sclerosis and optic neuritis.
Glatiramer is in Phase 2 development overall, and it is investigational rather than approved. Its completed studies include Phase 3 trials in relapsing remitting multiple sclerosis and optic neuritis, while the broader development program is tracked at the Phase 2 stage.
Four completed glatiramer trials are registered, including NCT01067521, a Phase 3 placebo-controlled study of 40 mg glatiramer acetate three times weekly in relapsing remitting multiple sclerosis with 1,404 participants, and NCT00856635, a Phase 3 study in acute optic neuritis. NCT01167426 and NCT00947752 also evaluated glatiramer formulations in relapsing remitting multiple sclerosis.
Yes, glatiramer is the same as glatiramer acetate, and the names are used interchangeably. Related search terms include glatiramer acetate 20 mg, glatiramer acetate 40 mg, and glatiramer acetate 20 mg/0.5 mL, which refer to the same active agent in different dose presentations.
Across four completed clinical trials, glatiramer has enrolled a total of 2,746 participants. The studies were randomized, double-blind, and placebo-controlled, and enrolled adults aged 18 years and older, including a Phase 3 relapsing remitting multiple sclerosis trial that randomized 1,404 patients.