GLOWA Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous Injection

Fecha de inicio: 1 de marzo de 2012

Inclusion Criteria: Subjects must meet all inclusion criteria in order to be eligible for the study: * Subjects must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the 2010 Revised McDonald criteria \[Ann Neurol 2011: 69:292-302\], with a relapsing-remitting disease course. * Subjects must be ambulatory with a 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 \[intravenous (IV), intramuscular (IM) and/or by mouth (PO)\] 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).