Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis

Sixty patients (20 patients at each recruiting center) with RR MS who satisfy both inclusion
and exclusion criteria will be treated with CellCept® or Avonex® for the first 6 months of
the study. Those patients will have a fifty-fifty chance of receiving either Avonex or
Cellcept. Baseline data will be collected before treatment begins including MRIs, chest
x-ray, EKG, and standard labwork, along with a blood test for HIV and Hepatitis B. Once
enrolled, study visits include periodic MRI scans, a neurological exam by the examining
neurologist every three months, frequent bloodwork, questionnaires, and eye-testing at month
zero, six, and twelve months. Eye testing takes about one hour and requires dilation of
pupils. All assessments are standard of care for ophthalmology with the exception of optical
coherence tomography (OCT)-- a non-invasive procedural device that records graphical and
numerical measurements of the optic nerve and macula.

All patients will begin active combination therapy on both CellCept® and Avonex® during the
second 6 months of the study. During this second phase, MRI and clinical examinations will be
performed.

Inclusion Criteria:

- Patient diagnosed with clinically definite MS according to McDonald criteria #1-#4

- Age 18-55

- Have a RR disease course

- Have EDSS scores less than or equal to 5.0

- Have a disease duration of one day to 20 years

- Have at least one medically documented clinical relapse within the 12 months prior to
randomization (for eligibility, a pre-study relapse will be defined as neurologic
symptoms and signs documented by review of the history with the subject or in the
medical record, of sufficient severity and duration to be determined by the
investigator as consistent with an acute MS relapse; the relapse does not need to have
been treated to qualify) and/or have progression of ≥1.0 points in EDSS in the
previous year

- Have ≥1 Gd-enhancing brain lesion on a monthly run-in baseline MRI and ≥2 T2 brain
lesions consistent with MS on the screening scan

- Signed informed consent

- None of the exclusion criteria

Exclusion Criteria:

- Previous treatment 3 months prior to study entry with standard disease-modifying
therapy (interferon-beta and glatiramer acetate, IVIG and plasmaphoresis).

- Previous treatment 12 months prior to study entry with immunosuppressant agents, e.g.,
mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body
irradiation or any other concomitant immunomodulatory therapies (e.g., azathioprine,
methotrexate,, CellCept®, natalizumab, and other immunomodulators/monoclonal agents).

- Patients who received steroid treatment 30 days prior to the MRI scan date

- Women who are pregnant, lactating or of childbearing age who do not consent to
approved contraceptive use during the study.

- Abnormal blood tests, performed during the screening visit (see adverse events
section)