Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis (RRMS), Glatiramer Acetate (GA)
Brief summary
The purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.
Interventions
DRUGGlatiramer Acetate
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.
DRUGExperimental Glatiramer Acetate
GA 20 mg/0.5 mL
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects ≥ 18 years of age with a diagnosis of RRMS * Currently injecting GA 20mg/1.0mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject®2 for glass syringe or by a manual injection technique * Willing to switch from autoject®2 for glass syringe to manual injection technique or continue with a manual injection technique during the course of the study * Willing and able to be trained on a seven site injection rotation. Subject must be willing to comply with a minimum five injection site rotation plan during the study * 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 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 intermittent or pulse courses of corticosteroids by any route of administration in the 30 days prior to screening for this study. (Corticosteroids are prohibited for the duration of the study.) * Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study * Presence or history of skin necrosis * Known extensive dermatological condition that could be a confounding factor * Pregnant or planning pregnancy or breastfeeding * Any physical condition that impairs ability to be injected at the minimum of five sites rotation * Not able or willing to complete a daily diary * 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 subject unsuitable for this research, as determined by the Investigator * Previous participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-reported Pain Associated Immediately After Each Injection | 5 weeks of injections | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Pain Within 5 Mins After Injection | 5 weeks of injections | 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. |
Participant flow
Recruitment details
Subjects were randomly assigned in a 1:1 assignment ratio to one of two drug sequences. Subjects were to manually inject GA (F1 or F2) once daily for 14 days then cross-over to the other formulation for another 14 days of treatment, including a 7-day run-in period on F1 treatment for all participants to assess daily diary compliance.
Pre-assignment details
To ensure the standardization, all study sites were instructed to train subjects to complete the daily diary, with special attention to the Visual Analog Scale (VAS) used to measure pain.
Participants by arm
| Arm | Count |
|---|---|
| F1 Glatiramer Acetate (GA) 20mg/1.0ml | 76 |
| F2 Glatiramer Acetate 20mg/0.5ml | 71 |
| Total | 147 |
Baseline characteristics
| Characteristic | F1 Glatiramer Acetate (GA) 20mg/1.0ml | F2 Glatiramer Acetate 20mg/0.5ml | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 71 Participants | 144 Participants |
| Age, Continuous | 45.1 years STANDARD_DEVIATION 10.64 | 46.9 years STANDARD_DEVIATION 9.64 | 46.0 years STANDARD_DEVIATION 10.17 |
| Sex: Female, Male Female | 61 Participants | 58 Participants | 119 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 147 | 0 / 147 |
| serious Total, serious adverse events | 0 / 147 | 0 / 147 |
Outcome results
Primary
Subject-reported Pain Associated Immediately After Each Injection
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.
Time frame: 5 weeks of injections
Population: Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F1 Glatiramer Acetate (GA) 20mg/1.0ml | Subject-reported Pain Associated Immediately After Each Injection | 11.89 Scores on a scale | Standard Deviation 14.325 |
| F2 Glatiramer Acetate 20mg/0.5ml | Subject-reported Pain Associated Immediately After Each Injection | 8.64 Scores on a scale | Standard Deviation 10.825 |
Secondary
Degree of Pain Within 5 Mins After Injection
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.
Time frame: 5 weeks of injections
Population: Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F1 Glatiramer Acetate (GA) 20mg/1.0ml | Degree of Pain Within 5 Mins After Injection | 17.19 Scores on a scale | Standard Deviation 18.583 |
| F2 Glatiramer Acetate 20mg/0.5ml | Degree of Pain Within 5 Mins After Injection | 11.85 Scores on a scale | Standard Deviation 14.112 |