The primary study [
MGTX] aims to answer three questions: does extended transsternal
thymectomy combined with the
prednisone protocol, when compared with the
prednisone protocol alone: (1) result in a greater improvement in myasthenic weakness, (2) result in a lower total dose of
prednisone, thus decreasing the likelihood of concurrent and long-term toxic effects, (3) enhance the quality of life by reducing adverse events and symptoms associated with the
therapies? Inclusion criteria are MGFA Class 2, 3, or 4;
acetylcholine receptor antibody positive; age at least 18.0 years and <60.0 years; MG history of <3 years. Patients can be
prednisone naïve or not. The National Institute for
Neurological Disorders and
Stroke awarded funding for
MGTX in September 2005, and NIH awarded funding for the ancillary
Biomarkers study (BioMG) in February 2006. Diverse regulatory obstacles have been encountered in this international study, but we now have a total of over 70 centers in 22 countries (North America, South America, Europe, Australasia, South Africa) either actively recruiting or at various levels of readiness.