A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis

Completed · Phase 3 · Has a placebo group

Conditions studied: Myasthenia Gravis, Generalized

In brief

The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00683969

Run by

Hoffmann-La Roche

People needed

136

Starts

2004-08-01

Expected to finish

2007-05-01

Last updated by the study team

2008-05-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients 18 to 80 years of age;
• diagnosis of myasthenia gravis;
• history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle;
• duration of myasthenia gravis symptoms (including ocular symptoms) <=10 years;
• prednisone dose >=20 mg/day (or equivalent alternate-day dose) for >=4 weeks.

You may not qualify if…

• female patients who are pregnant, breastfeeding, or lactating;
• regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 2 weeks prior to randomization;
• any prior clinically significant use of CellCept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization.

Where it is running

• Study site — Sun City, Arizona, United States
• Study site — Sacramento, California, United States
• Study site — Miami, Florida, United States
• Study site — Kansas City, Kansas, United States
• Study site — Rochester, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Upland, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Galveston, Texas, United States
• Study site — Edmonton, Alberta, Canada
• Study site — London, Ontario, Canada
• Study site — Bordeaux, France
• Study site — Nice, France
• Study site — Düsseldorf, Germany
• Study site — München, Germany
• Study site — Regensburg, Germany
• Study site — Tübingen, Germany
• Study site — Hyderabad, India
• Study site — Mumbai, India
• Study site — New Delhi, India
• Study site — Jerusalem, Israel
• Study site — Milan, Italy
• Study site — Roma, Italy
• Study site — San Donato Milanese, Italy

Full record on ClinicalTrials.gov

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