Safety of New Formulation of Glatiramer Acetate

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Glatiramer Acetate
* Drug: Experimental Glatiramer Acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: F1 Glatiramer acetate 20mg/1.0ml<br> | Drug: Glatiramer Acetate<br>* 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.<br>* Other names: F1;|
| Experimental: F2 Glatiramer acetate 20mg/0.5ml<br> | Drug: Experimental Glatiramer Acetate<br>* GA 20 mg/0.5 mL<br>* Other names: F2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 weeks of injections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 weeks of injections | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis (RRMS), Glatiramer Acetate (GA)