NCT00408213

A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.

A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone

• 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

This 2 arm study will provide optional continuation of double-blind treatment with CellCept or placebo, in patients with myasthenia gravis who have achieved good symptom control in study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

• Myasthenia Gravis Generalised

Interventions

Type	Name	Description
DRUG	mycophenolate mofetil [CellCept]	1g po bid
DRUG	Placebo	po bid

Timeline

• Start date: 2004-06-01
• Completion: 2007-09-01
• First posted: 2006-12-06
• Last updated: 2008-05-23

Locations

16 sites across 7 countries: United States, France, Germany, Italy, Serbia and Montenegro, Ukraine, United Kingdom