An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

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).