REbif FLEXible Dosing in Early Multiple Sclerosis (MS)

Exclusion Criteria

• •Diagnosis of MS (per McDonald criteria 2005)
• •Any other disease that could better explain the subject's signs and symptoms
• •Complete transverse myelitis or bilateral optic neuritis
• •Subject uses or has used any other approved MS disease-modifying drug (DMD)
• •Any investigational drug or undergone an experimental procedure within 12 weeks prior to study Day 1
• •Oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days prior to study Day 1
• •Total bilirubin greater than 2.5 times upper limit of normal (ULN)
• •Subject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase (ALP) greater than 2.5 times the ULN
• •Inadequate bone marrow reserve, defined as a total white blood cell count less than 3.0 x 109 per liter (/L), platelet count less than 75 x 109/L, hemoglobin less than 100 gram per liter (g/L)
• •Current autoimmune disease
• •Major medical or psychiatric illness (including history of or current severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
• •History of seizures not adequately controlled by treatment
• •Cardiac disease, such as angina, congestive heart failure or arrhythmia
• •Known allergy to IFN-beta or the excipient(s) of the study medication
• •Any condition that could interfere with the MRI evaluation;
• •Known allergy to gadolinium-diethylene triamine pentaacetic acid (DTPA)
• •Previously participated in this study
• •Participated in any clinical trial within the past 6 months
• •Any immunomodulatory or immunosuppressive therapy at any time prior to enrollment, including, but not limited to, the following products: any IFN, 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-cluster of differentiation 4 \[CD4\]), intravenous, immunoglobulins (Igs), cytokines or anti-cytokine therapy
• •Any experimental MS treatment prior to trial entry, including, but not limited to, any statins (if given to prevent MS) and pentoxyfylline
• •History of alcohol or drug abuse
• •Intolerance or any contraindication to both paracetamol (acetaminophen) and ibuprofen
• •Inability to administer subcutaneous injections either by self or by caregiver
• •Moderate to severe renal impairment