Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Neuroscience, Inc.
• Treatments: (T,G)-A-L; Glatiramer Acetate

Criteria

Inclusion Criteria:

• 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

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 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