Copaxone® Study to Follow Patients From the First Original Study for Safety and Effectiveness.

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 Sclerosis status.

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

Detailed description: 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 by patients.

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. Gender(s): Both.

Criteria:

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 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

process.

- 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.

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