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

Roche

Status and phase

Completed

Phase 3

Conditions

Myasthenia Gravis, Generalized

Treatments

Drug: mycophenolate mofetil (CellCept)

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00683969

WX17798

Details and patient eligibility

About

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.

Enrollment

136 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.