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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000343-28-DE

Enrollment

136

Registered

2005-05-10

Start date

2005-12-19

Completion date

Unknown

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis MedDRA version: 8.1 Level: PT Classification code 10028417 Term: Myasthenia gravis

Interventions

Trade Name: Cellcept 500 mg tablets Product Name: CellCept 500 mg tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mycophenolate mofetil Concentration unit: mg milligram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: to address investigator concerns about post-study treatment of subjects who have done well on double-blind treatment in Protocol WX17798 by providing the option to continue double-blind treatment until treatment assignment can be unblinded following database lock.;Secondary Objective: not applicable;Primary end point(s): Safety assessments: - Clinical laboratory tests (hematology, serum chemistry, urinalysis) - Monitoring of adverse events (AEs) - Physical examination, including clinical examination for tumors - Vital signs (blood pressure and heart rate) - Electrocardiograms (standard 12-lead tracing) - Record of all concomitant medications	—

Measure

Time frame

Main Objective: to address investigator concerns about post-study treatment of subjects who have done well on double-blind treatment in Protocol WX17798 by providing the option to continue double-blind treatment until treatment assignment can be unblinded following database lock.;Secondary Objective: not applicable;Primary end point(s): Safety assessments: - Clinical laboratory tests (hematology, serum chemistry, urinalysis) - Monitoring of adverse events (AEs) - Physical examination, including clinical examination for tumors - Vital signs (blood pressure and heart rate) - Electrocardiograms (standard 12-lead tracing) - Record of all concomitant medications

—

Countries

Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026