A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: RebiSmart™
Intervention description: The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the RebiSmart™ for

        -  ease of use

        -  multiple domains related to subject's acceptability and satisfaction

        -  reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in
           subjects with 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 or equal to twelve weeks

          4. Capable of self-injecting using the RebiSmart™ autoinjector. Self- injecting is
             defined as being able to make 2 of the 3 weekly injections without assistance.

          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, as defined by either:

               -  Being post-menopausal or surgically sterile, or using a highly effective method
                  of contraception (defined as a method that results in a low failure rate (i.e.
                  less than 1% per year) when used consistently and correctly, and includes for
                  instance, implants, injectables, combined oral contraceptives*, some intrauterine
                  devices, sexual abstinence or vasectomised partner)

               -  Female subjects of childbearing potential must have a negative pregnancy test at
                  Screening and Study Day 1 to be included in the trial. A urine pregnancy test
                  will also be done at the Week 12/Exit visit

                    -  Note for subjects using a hormonal contraceptive method: No formal drug
                       interaction studies have been carried out with Rebif®. As interferons have
                       been reported to exert an inhibitory activity on hepatic microsomal enzymes,
                       it is unlikely that the clearance of oral contraceptives would increase and
                       result in decreased efficacy. In over 10,000 patient years of clinical trial
                       experience with Rebif®, there has never been any indication of an
                       interaction with oral contraceptives.

        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