Trial Information

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

Status: No longer recruiting

Protocol Number: WX18411

Sponsor: Hoffmann-La Roche; Aspreva Pharmaceuticals Corporation

Company Division: Pharmaceutical

Official Scientific 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

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. 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. Target sample size is 136.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Myasthenia Gravis generalised

Intervention Type: Drug

Intervention Name: mycophenolate mofetil [CellCept]

Primary Outcome: 1. AEs, laboratory parameters, vital signs. Time frame: Throughout study

Key Secondary Outcomes: 1. None Time frame: None

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 80 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 09/18/2006

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:21:24 PM