To Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With RRMS (GLOW)

• Cumulative Number of New/Enlarged T2 Lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  The cumulative number of new, enlarging T2 lesions measured at months 6 and 12
• Cumulative number of Gd-enhancing lesions on T1-weighted images [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  The cumulative number of Gd-enhancing lesions on T1-weighted images measured at months 6 and 12
• Percent Brain Volume Change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Assess the development of brain atrophy as defined by the percent brain volume change at Month 12

This study will investigate the efficacy, safety and tolerability of a new formulation of Glatiramer Acetate, a strength of 20 milligrams (mg)/0.5 milliliters (mL) versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

• Drug: Glatiramer Acetate
  Glatiramer Acetate 20mg in 0.5ml for subcutaneous injection in a pre-filled syringe (PFS) is administered daily. Each PFS also contains 20mg mannitol dissolved in water for injection.
• Drug: Matching placebo
  Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.

• Experimental: Glatiramer Acetate
  Subjects are randomized to the Glatiramer Acetate or placebo groups in a 2:1 ratio.
  Intervention: Drug: Glatiramer Acetate
• Placebo Comparator: Placebo
  Subjects are randomized to the Glatiramer Acetate or placebo groups in a 2:1 ratio.
  Intervention: Drug: Matching placebo

Inclusion Criteria:

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

• Subjects must have a confirmed and documented MS diagnosis as defined by the 2010 Revised McDonald criteria [Ann Neurol 2011: 69:292-302] (see Appendix A), with a relapsing-remitting disease course.
• Subjects must be ambulatory with an Kurtzke's Expanded Disability Status Scale (EDSS) score of 0-5.5 in both screening and baseline visits.
• 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 (Adrenocorticotropic hormone) 30 days prior to screening (Month-1) and between screening and baseline (Month 0) visits.
• Subjects must have 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 a Magnetic Resonance Imaging (MRI) performed within 12 months prior to screening.
• Subjects must be between 18 and 55 years of age, inclusive.
• Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)].
• Subjects must be able to sign and date a written informed consent prior to entering the study.
• Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

Exclusion Criteria:

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

• Subjects with progressive forms of MS.
• Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
• Use of immunosuppressive agents (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
• Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
• Use of cladribine within 2 years prior to screening.
• Previous treatment with immunomodulators [including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg)] within 2 months prior to screening.
• Previous use of Glatiramer Acetate (GA) or any other glatiramoid.
• Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
• Previous total body irradiation or total lymphoid irradiation.
• Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
• Pregnancy or breastfeeding.
• 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.
• A known history of sensitivity to Gadolinium.
• (Glomerular Filtration Rate) GFR ≤ 60 mL/minute at the screening visit
• Inability to successfully undergo MRI scanning.
• A known drug hypersensitivity to Mannitol.
• Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).