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Brief Title: A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis
Study ID: NCT00683969
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Sun City, Arizona, United States
, Sacramento, California, United States
, Miami, Florida, United States
, Kansas City, Kansas, United States
, Rochester, New York, United States
, Chapel Hill, North Carolina, United States
, Columbus, Ohio, United States
, Upland, Pennsylvania, United States
, Dallas, Texas, United States
, Galveston, Texas, United States
, Edmonton, Alberta, Canada
, London, Ontario, Canada
, Belgrade, , Former Serbia and Montenegro
, Bordeaux Cedex, , France
, Nice, , France
, Düsseldorf, , Germany
, München, , Germany
, Regensburg, , Germany
, Tübingen, , Germany
, Hyderabad, , India
, Mumbai, , India
, New Delhi, , India
, Jerusalem, , Israel
, Milano, , Italy
, Roma, , Italy
, San Donato Milanese, , Italy
, Mexico City, , Mexico
, Mexico City, , Mexico
, Mexico City, , Mexico
, Leiden, , Netherlands
, Maastricht, , Netherlands
, Rotterdam, , Netherlands
, Kazan, , Russian Federation
, Moscow, , Russian Federation
, Nizhniy Novgorad, , Russian Federation
, Barcelona, , Spain
, Madrid, , Spain
, Kharkov, , Ukraine
, Kiev, , Ukraine
, Zaporozhye, , Ukraine
, Liverpool, , United Kingdom
, Oxford, , United Kingdom
, Salford, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche, 973-235-5000
Role: STUDY_DIRECTOR