drugset / Trial / NCT00408213

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

NCT00408213

Phase 3 Completed 136 enrolled Hoffmann-La Roche Aspreva Pharmaceuticals · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2004-06
Primary completion
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule 1 g Oral