NCT00683969

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis, Generalized

Interventions

Type	Name	Description
DRUG	mycophenolate mofetil (CellCept)	1g bid for 36 weeks
DRUG	placebo	po bid for 36 weeks

Timeline

• Start date: 2004-08-01
• Completion: 2007-05-01
• First posted: 2008-05-26
• Last updated: 2008-05-26

Locations

43 sites across 14 countries: United States, Canada, France, Germany, India, Israel, Italy, Mexico, Netherlands, Russia, Serbia and Montenegro, Spain, Ukraine, United Kingdom