A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis
The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to placebo in subjects with MG.
• Anti-acetylcholine receptor (AChR) antibody positive
• Confirmed diagnosis of generalized myasthenia gravis (MG).
• Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa inclusive at Screening.
• QMG >= 10 at Screening. Note: Subjects who only have a history of ocular MG may not enroll.
• Receiving standard of care MG treatment at a stable dose consisting of any one of the following for the time intervals delineated below (time intervals apply to medications and maintenance of stable dose level):
• Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening and no immunosuppressants
• Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening AND/OR only one of the following:
• Prednisone (up to 60 mg/day or equivalent) for at least 2 months prior to Screening, OR
• Azathioprine for at least 6 months prior to Screening, OR
• Mycophenolate mofetil for at least 6 months prior to Screening, OR
• Methotrexate for at least 6 months prior to Screening, OR
• Cyclosporine or tacrolimus for at least 3 months prior to Screening
• Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening AND/OR prednisone (up to 60 mg/day or equivalent) for at least one month prior to Screening and only one of the following:
• Azathioprine for at least 6 months prior to Screening, OR
• Mycophenolate mofetil for at least 6 months prior to Screening, OR
• Methotrexate for at least 6 months prior to Screening, OR
• Cyclosporine or tacrolimus for at least 3 months prior to Screening