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

Completed · Phase 3 · Has a placebo group

Conditions studied: Myasthenia Gravis Generalised

In brief

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.

Key facts

Study ID

NCT00408213

Run by

Hoffmann-La Roche

People needed

136

Starts

2004-06-01

Expected to finish

2007-09-01

Last updated by the study team

2008-05-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Study site — Sun City, Arizona, United States
• Study site — Sacramento, California, United States
• Study site — Upland, Pennsylvania, United States
• Study site — Bordeaux, France
• Study site — Nice, France
• Study site — München, Germany
• Study site — Regensburg, Germany
• Study site — Milan, Italy
• Study site — Roma, Italy
• Study site — Belgrade, Serbia and Montenegro
• Study site — Kharkiv, Ukraine
• Study site — Kiev, Ukraine
• Study site — Zaporizhzhya, Ukraine
• Study site — Liverpool, United Kingdom
• Study site — Oxford, United Kingdom
• Study site — Salford, United Kingdom

Full record on ClinicalTrials.gov

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