Safety of New Formulation of Glatiramer Acetate
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Glatiramer Acetate; Experimental Glatiramer Acetate
Intervention description: 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.; GA 20 mg/0.5 mL
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis (RRMS); Glatiramer Acetate (GA)

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.
    

Eligibility criteria:

        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