Multiple Sclerosis
Conditions
Keywords
Relapsing Remitting Multiple Sclerosis, RRMS, Clinically Isolated Syndrome, CIS, Copaxone, glatiramer acetate, Autoject 2
Brief summary
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.
Detailed description
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.
Interventions
DRUGGlatiramer Acetate 20 mg/0.5 mL
20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.
DRUGGlatiramer acetate 20 mg/0.5 mL
20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.
Sponsors
Teva Neuroscience, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 syringe for a minimum of 75% of daily injections * Willing and able to complete all procedures and evaluations related to the study * Willing to continue to follow usual injection site preparation and routine adjunctive local injection site reactions (LISR) management techniques * Willing and able to provide written informed consent
Exclusion criteria
* Currently using or treated with another immunomodulating therapy (IMT) in conjunction with GA in the 30 days prior to screening for this study * Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study * Pregnant or planning pregnancy or breastfeeding * Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.) either currently or in the past 30 days prior to screening for this study * Any other medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the Investigator * Unwilling to perform all daily injections with an autoject 2 device * Previous participation in any study evaluating the new 20 mg/0.5 mL formulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Week 2 to Week 6 in Composite Score of Patient 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Injection Experience Preference | Week 4 | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 148 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Sponsor Decision | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Glatiramer Acetate |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 140 Participants |
| Age Continuous | 48.1 years STANDARD_DEVIATION 10.29 |
| Duration of Glatiramer Acetate | 4.823 years STANDARD_DEVIATION 3.5539 |
| Duration of Multiple Sclerosis Disease | 10.167 years STANDARD_DEVIATION 9.0643 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 participants |
| Race/Ethnicity, Customized Other | 4 participants |
| Race/Ethnicity, Customized White | 141 participants |
| Region of Enrollment United States | 148 participants |
| Sex: Female, Male Female | 126 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 148 | 11 / 142 |
| serious Total, serious adverse events | 0 / 148 | 0 / 142 |
Outcome results
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.
Time frame: 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).
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glatiramer Acetate | Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience | Week 2 | 4.1 units on a scale | Standard Deviation 0.77 |
| Glatiramer Acetate | Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience | Week 6 | 4.8 units on a scale | Standard Deviation 0.46 |
| Glatiramer Acetate | Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience | Change from Week 2 to Week 6 | 0.7 units on a scale | Standard Deviation 0.79 |
Comparison: Comparison of Week 2 (20 mg/1.0 mL utilizing autoject 2 for glass syringe) to Week 6 (20 mg/0.5 mL utilizing the autoject 2 20 mg/0.5 mL).p-value: <0.0001Wilcoxon Signed-Rank
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).
Time frame: Week 4
Population: Analysis Population with available data.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Glatiramer Acetate | Patient Injection Experience Preference | Prefers First Experience | 9 participants | 6.2 |
| Glatiramer Acetate | Patient Injection Experience Preference | No Preference | 22 participants | — |
| Glatiramer Acetate | Patient Injection Experience Preference | Prefers Second Experience | 109 participants | — |
p-value: <0.0001Chi-squared