Myasthenia gravis MedDRA version: 7.1 Level: LLT Classification code 10028417
Conditions
Interventions
Trade Name: CellCept 500 mg
Product Name: CellCept
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
F.Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject of either sex, 18 to 80 years of age (inclusive) diagnosis of MG meeting all of the following criteria: history of myasthenic weakness involving more than ocular or peri-ocular muscles history of positive edrophonium chloride test OR abnormal neuromuscular transmission demonstrated by electrodiagnostic testing history of elevated AChR antibodies disease severity history: Myasthenia Gravis Foundation of America (MGFA) classification II, III, or IVa duration of MG symptoms (including ocular symptoms) = 10 years requirement of immunosuppressive therapy in the judgment of the investigator prednisone dose of =20mg/day (or equivalent alternate day dose) for at least 4 weeks prior to randomization if subject is taking a cholinesterase inhibitor (i.e. pyridostigmine bromide), a stable regimen is required for at least 2 weeks prior to randomization 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 receiving regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment or receiving PE or IVIG treatment within 2 weeks prior to randomization receiving MMF or other immunosuppressant therapy (except corticosteroids) within 8 weeks prior to randomization any prior clinically significant use of MMF or other immunosuppressant therapy (except corticosteroids) severe weakness of oropharyngeal and/or respiratory muscles (MGFA Class IVb or V; compromised airway protection; MG crisis or impending crisis) thymoma thymectomy within 6 months prior to randomization presence or history of: severe active gastrointestinal disease; persistent severe diarrhea; gastrointestinal hemorrhage active unhealed peptic ulcer within 3 months prior to randomization immune deficiency malignancy lymphoproliferative disease or previous total lymphoid irradiation chronic or frequent drug-resistant bacterial infections or presence of active infection requiring antimicrobial treatment frequent and/or serious viral infection systemic or invasive fungal disease within 2 years prior to randomization significant kidney or liver dysfunction pulmonary insufficiency requiring supplemental oxygen bone marrow insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: is to assess the efficacy of mycophenolate mofetil therapy compared to placebo in myasthenia gravis patients receiving prednisone;Secondary Objective: is to assess the safety and tolerability of mycophenolate mofetil therapy compared to placebo in mysthenia gravis patients receiving prednisone;Primary end point(s): Treatment groups will be compared to measure the proportion of subjects reaching responder status. A subject will be considered a responder if he or she meets all the following criteria: Minimal Manifestations or Pharmacologic Remission (MGFA Postintervention Status definitions modified) from Week 32 until study termination at Week 36 AND Prednisone dose of not more than 7.5 mg/day from Week 32 until study termination at Week 36 AND Cholinesterase inhibitor dose of =120 mg/day from Week 33* until study termination at Week 36 *subjects have one week to reduce cholinesterase inhibitor dose after reaching 7.5mg/day prednisone | — |
Countries
Czech Republic, Hungary, Italy, Spain
Outcome results
None listed