Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Rebif
Intervention description: 44 mcg tiw
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to evaluate the effects of Rebif® 44 mcg subcutaneous (sc) three
      times a week (tiw) on a) remyelination/demyelination, b) lesion and brain volume, c) central
      nervous system (CNS) iron deposition, and d) immune status in subjects with
      relapsing-remitting multiple sclerosis (RRMS) RRMS via several MRI techniques.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects, 18-65 years of age, inclusive, at the time of informed
             consent signature

          2. RRMS diagnosed according to the McDonald criteria, treatment naïve or currently using
             any of the FDA-approved DMDs (excluding natalizumab (Tysabri®), mitoxantrone or
             Rebif®)

          3. Have a disease duration of up to twenty years

          4. Be willing and able to comply with the study procedures for the duration of the trial

          5. Have given written informed consent and signed Health Insurance Portability and
             Accountability Act (HIPAA) Authorization before any study- related activities are
             carried out

          6. Female subjects must not be either pregnant or breast-feeding and must lack
             childbearing potential, as defined by either:

        The following inclusion criteria must be fulfilled by the Healthy Control subjects:

          1. Male and female subjects, 18-65 years of age, inclusive, at the time of informed
             consent signature

          2. Be willing and able to comply with the study procedures for the duration of the trial

          3. Have given written informed consent and signed Health Insurance Portability and
             Accountability Act (HIPAA) Authorization before any study- related activities are
             carried out

          4. Female subjects must not be either pregnant or breast-feeding and must lack
             childbearing potential, as defined by either:

        Exclusion Criteria:

          1. Have received treatment within three months prior to Screening with interferon-beta-1a
             (Rebif®), IVIG or plasmapheresis

          2. Have received treatment within thirty days prior to screening with immunosuppressant
             agents (e.g. including but not limited to mitoxantrone, cyclophosphamide, cladribine,
             fludarabine, cyclosporine or total body irradiation) or any other concomitant
             immunomodulatory therapies (e.g., azathioprine, methotrexate, CellCept®, natalizumab,
             alemtuzumab/Campath and other immunomodulators/monoclonal agents)

          3. Have had a relapse within thirty days prior to the Screening Visit

          4. Have received steroid treatment within thirty days prior to the initial MRI scan date
             at Study Day 1

          5. 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 >
             1.5x ULN

          6. Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x
             109/L, platelet count < 75x109/L, hemoglobin < 100g/L

          7. Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis

          8. Have a history of alcohol or drug abuse

          9. Have thyroid dysfunction

         10. Have moderate to severe renal impairment

         11. 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

         12. Have a history of seizures not adequately controlled by treatment

         13. Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled
             angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure

         14. Have, in the opinion of the investigator, any visual, physical or cognitive impairment
             that would preclude the subject from complying with the study protocol

         15. Have a known hypersensitivity or allergy to interferon-beta or any of the excipients

         16. Have received an investigational drug or experimental procedure within the past thirty
             days

         17. Are pregnant or attempting to conceive

        The following exclusion criteria must be fulfilled by the Healthy Control subjects:

        1. Have met any of the above noted criteria