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Adjunct CellCept (mycophenolate mofetil) with Reduced Corticosteroids in Subjects with Myasthenia Gravis

This study is currently recruiting patients.

Sponsored by: Hoffmann-La Roche
as part of the Aspreva Rare Disease Program
Information provided by: Hoffmann-La Roche

Purpose

Myasthenia gravis is a rare, debilitating neurological autoimmune disease. Mycophenolate mofetil (MMF) modulates autoimmune responses through a unique mode of action which may be relevant for autoimmune disease patients. This study will test the safety and efficacy of adjunct MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis.

Condition Treatment or Intervention Phase
Myasthenia Gravis
 Drug: mycophenolate mofetil
Phase III

MedlinePlus related topics:  Myasthenia Gravis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 Corticosteroids in Subjects with Myasthenia Gravis

Further Study Details: 

Expected Total Enrollment:  136

Study start: March 2004

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Major Inclusion Criteria:

Major Exclusion Criteria:


Location and Contact Information

For all locations and more details contact Trinh Le:      760-707-5032    trinh.le@chiltern.com

California
      Davis,  California,  United States; Recruiting

Florida
      Miami,  Florida,  United States; Recruiting

Illinois
      Chicago,  Illinois,  United States; Recruiting

Kansas
      Kansas City,  Kansas,  United States; Recruiting

New York
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Christine Blood  585-275-7867 
Emma Ciafaloni, M.D.  585-275-6372 
Emma Ciafaloni, M.D.,  Principal Investigator

North Carolina
      Chapel Hill,  North Carolina,  United States; Recruiting

      Durham,  North Carolina,  United States; Recruiting

Ohio
      Columbus,  Ohio,  United States; Recruiting

Texas
      The University of Texas Southwestern Medical Center, Dallas,  Texas,  75390,  United States; Recruiting
Marnie Tinney, RN  214-648-3417 
Gil Wolfe, M.D.,  Principal Investigator

Canada, Alberta
      Edmonton,  Alberta,  Canada; Recruiting

Canada, Ontario
      London,  Ontario,  Canada; Recruiting

Canada, Quebec
      Montreal,  Quebec,  Canada; Recruiting

More Information

Study ID Numbers:  WX17798
Record last reviewed:  October 2004
Record first received:  August 31, 2004
ClinicalTrials.gov Identifier:  NCT00090636
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09
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