Safety of New Formulation of Glatiramer Acetate

Phase 3

Completed

Interventions: Drug: Glatiramer Acetate
Drug: Experimental Glatiramer Acetate

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
F1 Glatiramer acetate 20mg/1.0ml	Glatiramer Acetate	-
F2 Glatiramer acetate 20mg/0.5ml	Experimental Glatiramer Acetate	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.