Status:
COMPLETED
Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
Lead Sponsor:
Teva Neuroscience, Inc.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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 ro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01167426
Start Date
July 1 2010
End Date
December 1 2010
Last Update
October 17 2013
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