Status:

COMPLETED

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

Lead Sponsor:

Hoffmann-La Roche

Collaborating Sponsors:

Aspreva Pharmaceuticals

Conditions:

Myasthenia Gravis Generalised

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

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. Pati...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2007

Estimated Enrollment :

136 Patients enrolled

Trial Details

Trial ID

NCT00408213

Start Date

June 1 2004

End Date

September 1 2007

Last Update

May 23 2008

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Sun City, Arizona, United States, 85351

2

Sacramento, California, United States, 95817

3

Upland, Pennsylvania, United States, 19013

4

Bordeaux, France

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