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Department of Neurology

FORTE

A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS)

Study Duration
Subjects will participate in the study for up to one month for the screening phase and 12 months for the double-blind treatment phase and 12 months for the open-label extension phase. The estimated time of participation will be 2 years with the first year allotted for recruitment of the 980 subjects and the second year for the last subjects enrolled to complete the study activities.

Key Inclusion Criteria
Subjects must meet all inclusion criteria in order to be eligible for the study:

  1. Subjects must have a confirmed and documented MS diagnosis as defined by the revised McDonald criteria.
  2. Subjects must be of the relapsing-remitting multiple sclerosis.
  3. Subjects must be relapse free and in stable neurological condition at least 30 days prior to screening.
  4. Subjects must have had experienced one of the following:
    • At least one documented relapse in the 12 months prior to screening
    • At least two documented relapses in the 24 months prior to screening
    • One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening
  5. Subjects must have disease duration of at least 6 months prior to screening.
  6. Subjects must be between 18 and 55 years of age, inclusive.
  7. Subjects must be ambulatory with converted Kurtzke EDSS score of 0-5.
  8. Women of child-bearing potential must practice an acceptable method of birth control .
  9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
  10. Subjects must be able to sign and date a written informed consent prior to entering the study.

Key Exclusion Criteria
Any of the following conditions will exclude the subject from entering the study:

  1. Any treatment with corticosteroids within 30 days prior to screening.
  2. An onset of relapse or any treatment with corticosteroids between month -1 (screening) and baseline.
  3. Chronic (more than 30 consecutive days) corticosteroids treatment (iv, im and/or po) within 6 months prior to screening visit.
  4. Use of cladribine within 2 years prior to screening.
  5. Previous total body or lymphoid irradiation.
  6. Use of immunosuppressive agents (including mitoxantrone) within 6 months prior to screening visit
  7. Previous treatment with immunomodulators [including IFNβ 1a and 1b, and iv Immunoglobulin (IVIg)] within 2 months prior to screening.
  8. Previous use of GA.
  9. Previous use of Natalizumab.
  10. Previous stem cell treatment.
  11. Use of experimental drugs (including TV-5010, laquinimod and oral GA) within 6 months prior to screening.
  12. Pregnancy or breastfeeding.
  13. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of alignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator’s judgment.
  14. Subject’s inability to complete the study, or if the subject is considered by the investigator to be for any reason, an unsuitable candidate for this study.
  15. A known history of sensitivity to mannitol.
  16. A known history of sensitivity to gadolinium (Gd).
  17. Inability to successfully undergo MRI scanning.
  18. Subjects with supraventricular tachycardia or other screening ECG abnormalities.

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