The Multicenter, Open-label, Single-use Autoinjector Convenience Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Rebidose®
Intervention description: The device is a ready to use single use auto injector containing Rebif® 44 mcg in a 0.5 mL prefilled syringe for sc injection
Phase: Phase 3
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b)
      multiple domains related to subject's acceptability and satisfaction, and c) reliability of
      the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing
      multiple sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects, 18-65 years of age, inclusive, at the time of informed
             consent signature

          2. RMS diagnosed according to the McDonald criteria

          3. Currently receiving Rebif® 44mcg sc tiw using manual injections and/or Rebiject II
             autoinjector for greater than twelve weeks

          4. Capable of self-injecting using the single-use autoinjector

          5. Be willing and able to comply with the study procedures for the duration of the trial

          6. Have given written informed consent and signed Health Insurance Portability and
             Accountability Act (HIPAA) Authorization before any study-related activities are
             carried out

          7. Female subjects must not be either pregnant or breast-feeding and must lack
             childbearing potential

        Exclusion Criteria:

          1. Have used any other injectable medications (i.e. 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 interferon, glatiramer acetate (Copolymer I),
             cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone,
             teriflunomide, laquinimod, cladribine, 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, haemoglobin < 100g/L

          5. Have complete transverse myelitis or 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, any visual, physical or cognitive impairment
             that would preclude the subject from self-injecting with the single-use 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