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

Completed · Phase 2

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00324506

Run by

University of Texas Southwestern Medical Center

People needed

43

Starts

2006-05-01

Expected to finish

2009-06-01

Last updated by the study team

2013-06-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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