A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.
Phase 3
Completed
- Conditions
- Myasthenia Gravis Generalised
- Interventions
- Drug: Placebo
- Registration Number
- NCT00408213
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 mycophenolate mofetil [CellCept] - 2 Placebo -
- Primary Outcome Measures
Name Time Method AEs, laboratory parameters, vital signs. Throughout study
- Secondary Outcome Measures
Name Time Method