Safety and Tolerability of Glatiramer Acetate
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: GA 20 mg/mL; GA 40 mg/mL
Intervention description: Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.; Glatiramer acetate (GA) 40 mg/mL subcutaneous (SC) injection, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.
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: None (Open Label)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Glatiramer Acetate; Glatiramer

Summary:

      This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and
      tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW)
      administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women at least 18 years of age or older

          2. Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised
             McDonald criteria, with relapse onset disease or a relapsing-remitting disease course

          3. Subjects must be ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS)
             score of 0-5.5 in both the Screening and Baseline visits.

          4. Subjects must be in a stable neurological condition, relapse-free and free of any
             corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or
             adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.

          5. Subjects must be treated with Glatiramer Acetate (GA) 20mg/mL QD SC injection for a
             minimum of 6 months prior to screening.

          6. 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 contraceptives, contraceptive patch, long-acting injectable
             contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm
             with spermicide)].

          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. Subject has any contraindication to Glatiramer Acetate therapy

          2. Subjects with progressive forms of multiple sclerosis (MS).

          3. Subjects with Neuromyelitis Optica (NMO).

          4. Use of experimental or investigational drugs, and/or participation in drug clinical
             studies within the 6 months prior to screening.

          5. Concomitant use of other disease modifying drug for MS ((Fingolimod (Gilenya®),
             dimethyl fumarate (Tecfidera®), Teriflunomide (Aubagio®) or intravenous immunoglobulin
             (IVIG)) within 6 months prior to screening

          6. Previous use of mitoxantrone, cladribine, alemtuzumab, rituximab, natalizumab.

          7. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid
             treatment within 6 months prior to screening visit.

          8. Previous total body irradiation or total lymphoid irradiation.

          9. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone
             marrow transplantation.

         10. Pregnancy or breastfeeding.

         11. 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 and abnormal laboratory tests. 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.

         12. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous
             Insufficiency (CCSVI).

         13. Employees of the clinical study site or any other individuals involved with the
             conduct of the study, or immediate family members of such individuals -