Overview

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

Status:
Completed

Trial end date:
2007-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hoffmann-La Roche

Collaborator:

Aspreva Pharmaceuticals

Treatments:

Mycophenolate mofetil
Mycophenolic Acid

Criteria

Inclusion Criteria:

- adult patients 18 to 80 years of age;

- diagnosis of myasthenia gravis;

- history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular
muscle;

- duration of myasthenia gravis symptoms (including ocular symptoms) <=10 years;

- prednisone dose >=20 mg/day (or equivalent alternate-day dose) for >=4 weeks.

Exclusion Criteria:

- female patients who are pregnant, breastfeeding, or lactating;

- regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG)
treatment, or PE or IVIG treatment within 2 weeks prior to randomization;

- any prior clinically significant use of CellCept or other immunosuppressive therapy
(except corticosteroids), or within 8 weeks prior to randomization.