Copaxone┬« Study to Follow Patients From the First Original Study for Safety and Effectiveness.
Information source: Teva Pharmaceutical Industries
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: glatiramer acetate (Drug); mannitol (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Teva Pharmaceutical Industries
Official(s) and/or principal investigator(s):
Kenneth Johnson, MD, Study Director, Affiliation: University of Maryland
Patients have scheduled visits every 3 months to assess Copaxone safety and their Multiple
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«
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: EDSS for efficacy every 6 months and adverse events for safety every 3 months.
Secondary outcome: MRI data & Quality Of Life data periodically during study
Open label study to evaluate the safety of Copaxone and its effect on the neurologic course
of patients with relapsing-remitting MS. Copaxone« Injection, a clear, colorless to slightly
yellow, sterile, non-pyrogenic solution for subcutaneous injection is be self-injected daily
After all eligibility criteria for each patient was met treatment commenced for that patient.
Patients will be evaluated every three months for safety and every six months for change in
neurological status. Neurological examinations include Functional system evaluation, Kurtzke,
Expanded Disability Status score, Ambulation Index.
The eleven University Hospital centers in the United States which participated in the
Double-Blind Study (Protocol 01-9001) collaborate in the conduct of the study.
Minimum age: 18 Years.
Maximum age: 50 Years.
- 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 meet the criteria of clinically definite MS as defined by Poser. 5
- The patient's signs and symptoms cannot be better explained by another disease
- 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.
- 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.
Locations and Contacts
UCLA Neurological Services, Los Angeles, California 90095, United States
USC Department of Neurology, Los Angeles, California 90033, United States
Yale MS Research Center, New Haven, Connecticut 06520, United States
The Maryland Center for M.S., Baltimore, Maryland 21201, United States
University Health Center 8B, Detroit, Michigan 48201, United States
UNM School of Medicine, Albuquerque, New Mexico 87131, United States
University of Rochester, Rochester, New York 14642, United States
Univ. of PA Medical Center, Dept. of Neuro., Philadelphia, Pennsylvania 19104, United States
University of Texas HSC-Houston, Houston, Texas 77030, United States
VA Medical Center, Salt Lake City, Utah 84148, United States
UW Hospital & Clinic, Madison, Wisconsin 53792, United States
Starting date: July 1994
Ending date: July 2012
Last updated: January 9, 2008