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

Multiple Sclerosis Clinical Trial

Official title:
A Randomized, Open-label, Parallel-Group Multicenter Study to Determine the Safety/Efficacy of Mycophenolate Mofetil in Mono & Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple Sclerosis

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00324506
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase Phase 2
Start date May 2006
Completion date June 2009
View Details
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