Efficacy and Safety of GTR in Comparison to Copaxone®

Exclusion Criteria

• •Any life-threatening, medically unstable or otherwise clinically significant condition or findings other than MS, in particular neoplastic disease, seizure disorders, or psychiatric disease;
• •Any clinically significant deviation from reference ranges in laboratory tests;
• •Positive laboratory test results for human immunodeficiency virus (HIV), HBsAg or HCV at screening;
• •Any significant deviation from reference ranges for hepatic function;
• •Positive urine drug screen or history of substance abuse within the year before screening (any use of illicit or prescription drugs or alcohol constituting an abuse pattern in the opinion of the investigator);
• •Having been treated with or having received
• •1. at any time:
• •* glatiramer acetate, cladribine, rituximab, cyclophosphamide, alemtuzumab, or other immunosuppressive treatments with effects potentially lasting for more than 6 months
• •* total lymphoid irradiation or bone marrow transplantation
• •2. within one year before screening:
• •* mitoxantrone, but subject cannot be enrolled when mitoxantrone was taken at a cumulative lifetime dosing above 100 mg/m2
• •3. within 6 months before screening:
• •* fingolimod, immunoglobulins and/or monoclonal antibodies (including natalizumab), leflunomide, or putative MS treatments
• •* chronic oral or injected corticosteroids or injected ACTH (more than 30 consecutive days)
• •4. within 3 months before screening:
• •* azathioprine, methotrexate
• •* plasma exchange
• •* any other experimental intervention, in particular experimental drugs
• •5. within 1 month before screening:
• •* Interferon-β 1a or 1b
• •* short-term oral or injectable corticosteroids for treatment of a relapse
• •* short-term ACTH
• •Having, in the opinion of the investigator, consecutively failed on efficacy grounds two full and adequate courses of accepted treatment modalities (normally at least one year of treatment for each);
• •Pregnancy or breastfeeding;
• •Known hypersensitivity to gadolinium-containing products, glatiramer acetate or mannitol;
• •Having an estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2;
• •Inability to undergo (repeat) MRI investigations as judged by the investigator, e.g. due to claustrophobia, metal implants or fragments, tattoos or permanent make-up;
• •Any reason why, in the investigator's opinion, the subject should not participate.