Safety/Effectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS

Inclusion Criteria:

• male and female patients between the ages of 18-55 years inclusive
• have provided informed consent to be screened for the study
• have been diagnoses as having MS
• meet the McDonald diagnostic criteria for RRMS or CHAMPS criteria for CIS
• have an EDSS score of 0.0-3.5
• have had no immunomodulator or cytoxic agents and have had no steroids or other immunosuppressants within 30 days prior to Baseline Visit
• must have had a brain MRI scan demonstrating lesions consistent with MS on T2-weighted or FLAIR images
• subjects must be willing and able to participate in all aspects of the study, including use of study medications as prescribed, and screening and follow-up clinical and MRI assessments

Exclusion Criteria:

• type I of type II diabetes
• uncontrolled hypertension (systolic >160 or diastolic >100 despite medication therapy)
• history of suicidal ideation
• history of psychosis
• history of alcoholism or other substance abuse
• clinically significant coronary artery disease
• history of hepatic failure and chronic renal failure
• history of cancer other than basal or squamous cell carcinoma of the skin
• pregnancy or unwillingness to use adequate precautions to prevent pregnancy during the duration of this study
• nursing mothers
• history of stroke, dementia, seizure disorder, peripheral neuropathy, Parkinsonism, myasthenia, myelopathy or other primary degenerative disease of the central or peripheral nervous system
• history of peptic ulcer disease
• history of intolerance to corticosteroids or allergy to albumin
• history of osteoporosis
• history of Lupus, Sjogrens syndrome, Lyme disease or syphilis
• abnormal laboratory results indicative of significant hepatic, renal, hematopoetic, or coagulation dysfunction
• the entity of any disease entity, which in the opinion of the investigators would potentially prevent the patient from successfully completing 2 years participation in this trial or confound the observations made during this trial
• prior use of Avonex, Betaseron, Rebif, mitoxantrone, cyclophosphamide, azothioprine, methotrexate, cladribine, cyclosporin, CellCept, IVIG, natalizumab, anti T-cell or anti B-cell antibodies, plasmapheresis or other systemic immunosuppressant or cancer chemotherapeutic agents
• unwillingness or inability to comply with all the requirements of the protocol
• known diagnosis of osteoporosis