Trial information
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 type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
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:
- 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.
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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Germany
Italy
Ukraine
United Kingdom
United States
