The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing multiple sclerosis. Safety will be assessed by virtue of changes in size and number of lesions on MRI scans.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
Michigan Institute for Neurological Disorders (M.I.N.D.)
Farmington Hills, Michigan, United States
Buffalo Neuroimaging Analysis Center (BNAC)
Buffalo, New York, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing multiple sclerosis. Safety will be assessed by virtue of changes in MRI
Time frame: 1 year
Secondary Objectives:
Time frame: one year
Changes in exacerbation frequency, incidence of exacerbations in the treated groups, changes in level of sustained disability
Time frame: one year
, changes in quality of life measures, assessment of fatigue
Time frame: one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.