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

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.

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Key information

Conditions

Myasthenia Gravis Generalised

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mycophenolate mofetil [CellCept]

Drug

1g po bid

Placebo

Drug

po bid

Primary outcomes

AEs, laboratory parameters, vital signs.

Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

Aspreva Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start: 2004
Study completion: 2007
First posted: Dec 6, 2006
Registry last updated: May 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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