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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00408213

Enrollment

136

Registered

2006-12-06

Start date

2004-06-30

Completion date

2007-09-30

Last updated

2008-05-23

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

Conditions

Myasthenia Gravis Generalised

Brief 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.

Interventions

DRUGmycophenolate mofetil [CellCept]

1g po bid

DRUGPlacebo

po bid

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

* subjects who have completed 36 weeks of treatment in study WX17798, and who have demonstrated good symptom control with a stable prednisone dose for the final 4 weeks of that study.

Exclusion criteria

* regularly scheduled plasma exchange or intravenous immunoglobulin treatment; * medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.

Design outcomes

Primary

Measure	Time frame
AEs, laboratory parameters, vital signs.	Throughout study

Countries

France, Germany, Italy, Serbia and Montenegro, Ukraine, United Kingdom, United States

Outcome results

None listed

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