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This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.
The study will consist of a 2 week treatment period with participants injecting their current therapy of Copaxone 20 mg/1.0 mL glatiramer acetate utilizing an autoject 2. All participants will then roll over to the new formulation of 20 mg/0.5 mL glatiramer acetate with an autoject 2 device for a 4 week treatment period. Patient satisfaction will be evaluated using an Experience Questionnaire throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glatiramer Acetate 20 mg/0.5 mL | Drug | 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience | 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. | Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Injection Experience Preference | The Injection Experience Preference Questionnaire utilizes a 5-level preference scale where participants were asked to compare their injection experience during the first 2 weeks (glatiramer acetate 20 mg/1 mL) with the past 2 weeks (glatiramer acetate 20 mg/0.5 mL). Response options were: 1. "strongly prefer first experience (first 2 weeks)"; 2. "somewhat prefer first experience (first 2 weeks)"; 3. "no preference"; 4. "somewhat prefer second experience (past 2 weeks)"; 5. "strongly prefer second experience (past 2 weeks)." Responses 1 and 2 were combined into a single category (prefers first experience) and responses 4 and 5 were combined into a single category (prefers second experience). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Smith, MD | Teva Neuroscience, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glatiramer Acetate | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Glatiramer Acetate | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience | 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. | The Analysis Population consisted of of all patients who received at least one dose of study medication and had satisfaction data at time points 2 and 6 weeks, 2 and 4 weeks, or 2, 4 and 6 weeks. | Posted | Mean | Standard Deviation | units on a scale | Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation). |
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All patients who receive at least 1 dose of study medication were included in the Safety population. 148 patients were exposed to the 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe and 142 patients were exposed to the 20 mg/0.5 mL formulation utilizing the autoject 2 20 mg/0.5 mL device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: Glatiramer Acetate 20 mg/1.0 mL | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Smith, MD | Teva Pharmaceuticals Medical Affairs | 816-508-5128 | tom.smith@tevapharm.com |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Glatiramer acetate 20 mg/0.5 mL | Drug | 20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device. |
|
| Week 4 |
| Sponsor Decision |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Duration of Glatiramer Acetate | Mean | Standard Deviation | years |
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| Duration of Multiple Sclerosis Disease | Mean | Standard Deviation | years |
|
| Description |
|---|
| OG000 | Glatiramer Acetate | 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). |
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|
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| Secondary | Patient Injection Experience Preference | The Injection Experience Preference Questionnaire utilizes a 5-level preference scale where participants were asked to compare their injection experience during the first 2 weeks (glatiramer acetate 20 mg/1 mL) with the past 2 weeks (glatiramer acetate 20 mg/0.5 mL). Response options were: 1. "strongly prefer first experience (first 2 weeks)"; 2. "somewhat prefer first experience (first 2 weeks)"; 3. "no preference"; 4. "somewhat prefer second experience (past 2 weeks)"; 5. "strongly prefer second experience (past 2 weeks)." Responses 1 and 2 were combined into a single category (prefers first experience) and responses 4 and 5 were combined into a single category (prefers second experience). | Analysis Population with available data. | Posted | Number | participants | Week 4 |
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|
| 0 |
| 148 |
| 0 |
| 148 |
| EG001 | Period 2: Glatirimer Actetate | Participants received once daily subcutaneous administration of glatiramer acetate 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2). | 0 | 142 | 11 | 142 |
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
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