An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis)

• Conditions: Myasthenia Gravis; MedDRA version: 8.1Level: PTClassification code 10028417Term: Myasthenia gravis

• Registration Number: EUCTR2005-000343-28-DE
• Lead Sponsor: Aspreva Pharmaceuticals Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-10
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Subjects who :
- provide written informed consent for this optional double-blind treatment continuation study.
- have completed 36 weeks of treatment with double-blind (MMF or placebo) in Protocol WX17798,
- achieved good symptom control with a stable prednisone dose. Good symptom control is defined as Minimal Manifestations or Pharmacologic Remission (MGFA Postintervention Status definitions modified) from Week 32 until study termination at Week 36 of Protocol WX17798. Stable prednisone dose is defined as no change in prednisone dose required after Week 32.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnancy, breastfeeding or lactation, or use of a non-reliable method of contraception.
- Receiving regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment.
- Participation in another clinical trial and/or receipt of investigational drugs during the double-blind continuation.
- Use of other prohibited medications
- Medical condition, adverse event or intolerance of double-blind treatment that would preclude continuation, including:thymoma, congenital or acquired immunodeficiency, malignancy or lymphoproliferative disease, serious bacterial infection, uncontrolled thyroid disease. Please see the protocol for the full list.
- Other medication condition which in the investigator's judgement may be associated with increased risk to the subject.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified