Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness

Completed · Phase 4

Conditions studied: Relapsing-Remitting Multiple Sclerosis

In brief

This open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (RRMS). Participants have scheduled visits every 3 months to assess glatiramer acetate safety and their Multiple Sclerosis (MS) status.

Key facts

Study ID

NCT00203021

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

208

Starts

1994-03-26

Expected to finish

2018-02-28

Last updated by the study team

2020-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have participated (been randomized) in the Copaxone double-blind placebo-controlled study 01-9001 and/or the double-placebo-controlled extension study 01-9001E.
• Participants could be male or female. Women of childbearing potential must have practiced an acceptable method of birth control.
• Participants must have completed the scheduled termination visit for Amendment 12 (Month 264).
• Participants must have signed an approved informed consent form (ICF) prior to continuing in the study extension or at the first visit in the extension (Month 264 which corresponds to the termination visit of Amendment 12).
• Participants must have been psychologically and physically stable to participate in the trial as judged by the investigator.
• All participants enrolled in this extension study were required to have the following study-specific baseline characteristics prior to entry to Study 01-9001: a diagnosis of RRMS as defined by Poser et al 1983, at least 2 clearly identified relapses and remissions in the 2-year period prior to study entry, ambulatory with a Kurtzke EDSS score of 0 to 5.0 inclusive, and a stable neurologic state for at least 30 days prior to study entry.

You may not qualify if…

• Pregnancy or lactation.
• Medical or psychiatric conditions that affect the participant'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 approved MS therapies including interferons, experimental MS therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine).

Where it is running

• Teva Investigational Site 009 — Los Angeles, California, United States
• Teva Investigational Site 004 — Los Angeles, California, United States
• Teva Investigational Site 008 — New Haven, Connecticut, United States
• Teva Investigational Site 005 — Baltimore, Maryland, United States
• Teva Investigational Site 003 — Detroit, Michigan, United States
• Teva Investigational Site 002 — Albuquerque, New Mexico, United States
• Teva Investigational Site 007 — Rochester, New York, United States
• Teva Investigational Site 001 — Philadelphia, Pennsylvania, United States
• Teva Investigational Site 010 — Houston, Texas, United States
• Teva Investigational Site 006 — Salt Lake City, Utah, United States
• Teva Investigational Site 011 — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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