Myasthenia Gravis Inebilizumab Trial

Korábbi kezelés

• Receipt of the following medications within the 4 weeks prior to Day 1:
  • Cyclosporine (except eye drops)
  • Tacrolimus (except topical)
  • Methotrexate
• Current use of:
  • Corticosteroids (Prednisone \> 40 milligram (mg)/day or \> 80 mg over a 2-day period (or equivalent dose of other corticosteroids).
  • Acetylcholinesterase inhibitors (pyridostigmine) \> 480 mg/day) or unstable dose in the 2 weeks prior to Day 1.
  • Azathioprine \> 3 mg/kilogram (kg)/day
  • Mycophenolate mofetil \> 3 grams/day or mycophenolic acid \> 1440 mg/day
  • Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.

• Diagnosis of MG with anti-AChR or anti-MuSK antibody.
• MGFA Clinical Classification Class II, III, or IV.
• MG-ADL score of 6 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items.
• QMG score of 11 or greater.
• Participants must be on:
  • Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
  • One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
  • Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.
  • Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.