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

Hoffmann-La Roche136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

136

Conditions

Myasthenia Gravis Generalised

Interventions

mycophenolate mofetil [CellCept]DRUG

1g po bid

PlaceboDRUG

po bid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (16)

Unnamed facility

Sun City, Arizona, United States

Unnamed facility

Sacramento, California, United States

Unnamed facility

Upland, Pennsylvania, United States

Outcomes

Primary Outcomes

AEs, laboratory parameters, vital signs.

Time frame: Throughout study

Data from ClinicalTrials.gov

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