A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study

Exclusion Criteria

• •1. Have used any other injectable medications (e.g. for pain) on a regular basis during the week prior to Screening or throughout the duration of the trial (the administration of a single injection for treatment or prophylaxis of a condition unrelated to MS or Rebif® therapy (e.g., influenza or pneumococcus vaccination) will be acceptable)
• •2. Have received MS therapy other than Rebif® within twelve weeks prior to Screening or at any time during the trial (e.g., other disease modifying drugs, Rebif® New Formulation, combination therapy, immunomodulatory and/or immunosuppressive agents, including but not limited to any other interferon (Avonex/Betaseron/Extavia), glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, fingolimod (FTY720), total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (e.g. natalizumab, alemtuzumab/Campath, anti-CD4), Intravenous immunoglobulin (IVIg), cytokines or anti-cytokine therapy) and telbivudine
• •3. Have inadequate liver function, defined by a alanine aminotransferase (ALT) \> 2.5x upper limit of normal (ULN), or alkaline phosphatase \> 2.5x ULN, or total bilirubin \> 2.5x ULN
• •4. Have inadequate bone marrow reserve, defined as a total white blood cell count \< 3.0x 109/L, platelet count \< 75x109/L, hemoglobin \< 100g/L
• •5. Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis
• •6. Have a history of alcohol or drug abuse
• •7. Have thyroid dysfunction
• •8. Have moderate to severe renal impairment
• •9. Have a major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
• •10. Have a history of seizures not adequately controlled by treatment
• •11. Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
• •12. Have, in the opinion of the investigator, major visual, physical or cognitive impairment that would preclude the subject from self-injecting with the RebiSmart™ autoinjector
• •13. Have a known hypersensitivity or allergy to interferon-beta or any of the excipients
• •14. Have participated in another clinical trial within the past thirty days
• •15. Are pregnant or attempting to conceive
• •16. Have previously used a RebiSmart™ autoinjector