Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Glatiramer acetate
Intervention description: Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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).