Overview

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