A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Sep 12, 2005

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinically definite MS with disease duration (from onset) of at least 6 months.
• • 2. Subjects must have had at least 1 documented relapse within the last year prior to study entry.
• • 3. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.
• • 4. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
• • 5. Subjects must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits.
• • 6. Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, or double-barrier method (condom or IUD with spermicide).
• • 7. Subjects must be between the ages of 18 and 50 years inclusive.
• • 8. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5 inclusive.
• • 9. Subjects must be willing and able to give written informed consent prior to entering the study.
• Exclusion Criteria:
• • 1. Previous use of glatiramer acetate (oral or injectable).
• • 2. Previous use of cladribine.
• • 3. Previous use of immunosuppressive agents in the last 6 months.
• • 4. Use of experimental or investigational drugs, including I.V. immunoglobulin, and/or participation in an investigational drug study within 6 months prior to study entry.
• • 5. Use of interferon agents within 60 days prior to the screening visit.
• • 6. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
• • 7. Previous total body irradiation or total lymphoid irradiation (TLI).
• • 8. Pregnancy or breast feeding.
• • 9. Patients who experience a relapse between the screening (month -1) and baseline (month 0) visits.
• • 10. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse.
• • 11. A known history of sensitivity to mannitol.
• • 12. A known sensitivity to gadolinium.
• • 13. Inability to successfully undergo MRI scanning.