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)
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Glatiramer Acetate; Placebo
Intervention description: 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.; Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.
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: Double (Participant, Investigator)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will investigate the efficacy, safety and tolerability of a new formulation of
      glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with
      Relapsing-Remitting Multiple Sclerosis (RRMS).
    

Eligibility criteria:

        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).