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

Myasthenia Gravis Generalised Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408213
• Other study ID #: WX18411
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2006
• Last updated: May 22, 2008
• Start date: June 2004
• Est. completion date: September 2007

Study information

• Verified date: May 2008
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00231088

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myasthenia Gravis
• Myasthenia Gravis Generalised

Intervention

Drug:
• mycophenolate mofetil [CellCept]
1g po bid
• Placebo
po bid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Aspreva Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs, laboratory parameters, vital signs.		Throughout study	No