Copaxone® Study to Follow Patients From the First Original Study for Safety and Effectiveness.
This trial is active, not recruiting.
|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|
|Los Angeles, CA||Teva Investigational Site 004||no longer recruiting|
|Los Angeles, CA||Teva Investigational Site 009||no longer recruiting|
|New Haven, CT||Teva Investigational Site 008||no longer recruiting|
|Baltimore, MD||Teva Investigational Site 005||no longer recruiting|
|Detroit, MI||Teva Investigational Site 003||no longer recruiting|
|Albuquerque, NM||Teva Investigational Site 002||no longer recruiting|
|Rochester, NY||Teva Investigational Site 007||no longer recruiting|
|Philadelphia, PA||Teva Investigational Site 001||no longer recruiting|
|Houston, TX||Teva Investigational Site 010||no longer recruiting|
|Salt Lake City, UT||Teva Investigational Site 006||no longer recruiting|
|Madison, WI||Teva Investigational Site 011||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Open label treatment
EDSS for efficacy every 6 months and adverse events for safety every 3 months.
time frame: 26 years
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.
|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®|
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