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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00683969

Enrollment

136

Registered

2008-05-26

Start date

2004-08-31

Completion date

2007-05-31

Last updated

2008-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis, Generalized

Brief 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.

Interventions

DRUGmycophenolate mofetil (CellCept)

1g bid for 36 weeks

DRUGplacebo

po bid for 36 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Proportion of subjects reaching responder status	Week 36

Secondary

Measure	Time frame
Time to start of response	Event driven
Mean and median prednisone dose and cholinesterase inhibitor dose	Week 36
Adverse events, lab parameters, vital signs	Throughout study

Countries

Canada, France, Germany, India, Israel, Italy, Mexico, Netherlands, Russia, Serbia and Montenegro, Spain, Ukraine, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026