A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Glatiramer acetate (GA); Placebo
Intervention description: GA 40 mg/mL administered 3 times a week by subcutaneous injection for a period of 12 months for participants assigned to GA treatment in the Double-Blind Period, and GA 40 mg/mL administered 3 times a week by subcutaneous injection for all participants in the Open-Label Extension Period.; Placebo comparator administered by subcutaneous injection three times each week for 12 months during the Double-Blind Period.
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1404.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing Remitting Multiple Sclerosis; Glatiramer Acetate

Summary:

      The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg
      administered three times a week compared to placebo in subjects with RRMS, as measured by the
      number of confirmed relapses during the 12 month placebo controlled period. The study has two
      periods:

        -  Placebo Controlled Period: 12 months of 40 mg administered three times a week by
           subcutaneous injection or matching placebo.

        -  Open Label Extension Period: All subjects will continue treatment with GA 40 mg
           administered three times a week, until this dose strength is commercially available for
           the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the
           development of this GA dose regimen is stopped by the Sponsor
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised
             McDonald criteria with a relapsing-remitting disease course.

          2. Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline
             visits.

          3. Subjects must be in a relapse-free, stable neurological condition and free of
             corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or
             ACTH 30 days prior to screening (month -1) and between screening and baseline (month
             0) visits.

          4. Subjects must have experienced one of the following:

             At least one documented relapse in the 12 months prior to screening, or At least two
             documented relapses in the 24 months prior to screening, or 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 be between 18 and 55 years of age, inclusive.

          6. Women of child-bearing potential must practice an acceptable method of birth control.

          7. Subjects must be able to sign and date a written informed consent prior to entering
             the study.

          8. Subjects must be willing and able to comply with the protocol requirements for the
             duration of the study

        Exclusion Criteria:

          1. Subjects with progressive forms of MS.

          2. Use of experimental or investigational drugs, and/or participation in drug clinical
             studies within the 6 months prior to screening.

          3. Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents
             within 6 months prior to the screening visit.

          4. Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior
             to screening.

          5. Use of cladribine within 2 years prior to screening.

          6. Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV
             Immunoglobulin (IVIg) within 2 months prior to screening.

          7. Previous use of GA or any other glatiramoid.

          8. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid
             treatment within 6 months prior to screening visit.

          9. Previous total body irradiation or total lymphoid irradiation.

         10. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone
             marrow transplantation.

         11. Pregnancy or breastfeeding.

         12. 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 malignancy, major
             psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be
             detrimental according to the investigator's judgment.

         13. A known history of sensitivity to Gadolinium.

         14. Inability to successfully undergo MRI scanning.

         15. A known drug hypersensitivity to Mannitol.