Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teva Neuroscience, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
