This trial is active, not recruiting.

Condition multiple sclerosis
Treatment glatiramer acetate
Phase phase 4
Sponsor Teva Branded Pharmaceutical Products, R&D Inc.
Start date July 1994
End date August 2019
Trial size 102 participants
Trial identifier NCT00203021, GA-9004


Patients have scheduled visits every 3 months to assess Copaxone safety and their Multiple Sclerosis status.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Open label treatment
glatiramer acetate Copaxone®
Glatiramer acetate 20mg and mannitol 40mg contained in same pre-filled syringe; subcutaneous injection once daily.

Primary Outcomes

EDSS for efficacy every 6 months and adverse events for safety every 3 months.
time frame: 26 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients must have participated (been randomized) in the Copaxone Double-Blind placebo controlled study (Protocol 01-9001). - Gender: Patients may be male or female. Women of childbearing potential must practice an acceptable method of birth control. - Patients must sign an approved informed consent prior to initiating the study. - Patients must be psychologically and physically stable to participate in the trial as judged by the investigator. Exclusion Criteria: - Pregnancy or lactation. - Medical or psychiatric conditions that affect the patient's ability to give informed consent or complete the study. - Inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily. - Use of Interferons, experimental MS therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine), or total lymphoid irradiation within 30 days of study entry.

Additional Information

Official title Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone®
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Teva Pharmaceutical Industries.