Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teva Branded Pharmaceutical Products R&D, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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).
