MGTX Thymectomy Surgery Study

Abstracts of Articles about the MTGX Study

Development of a thymectomy trial in non-thymomatous myasthenia gravis patients receiving immunosuppressive therapy. Wolfe G, Kaminski HJ Jaretzki A, Swan A, Newsom-Davis J. Ann. N.Y. Acad. Sci. 998 (2003), 473-480.

Abstract: Thymectomy has been regularly used in the management of nonthymomatous autoimmune myasthenia gravis (MG), but its benefits have not been established in a randomized, controlled trial. The widespread use of thymectomy in MG patients without thymoma is largely based on retrospective, nonrandomized case series that have produced a consensus that the procedure is sometimes beneficial. Still, the benefits and utilization of thymectomy are actively debated among MG experts. In this paper, we describe the development of a multicenter, international trial to determine whether extended transsternal thymectomy reduces corticosteroid requirements for patients with generalized AChR antibody-positive nonthymomatous MG.

The MGTX experience: Challenges in planning and executing an international, multicenter clinical trial. Aban IB, Wolfe GI, Cutter GR, Kaminski HJ, Jaretzki A, MinismanG, Conwit R, Newsom-Davis J, MGTX Advisory Committee. Journal of Neuroimmunology 201-202 (2008), 80-84.

Abstract: We present our experience planning and launching a multinational, NIH/NINDS funded study of thymectomy in myasthenia gravis. We highlight the additional steps required for international sites and analyze and contrast the time investment required to bring U.S. and non-U.S. Sites, into full regulatory compliance. Results show the mean time for non-U.S. centers to achieve regulatory approval was significantly longer (mean 13.4±0.96 months) than for U.S. sites (9.67±0.74 months; p=0.0175, t-test). The delay for non-U.S. sites was mainly attributable to Federalwide Assurance certification and State Department clearance. © 2008 Elsevier B.V. All rights reserved.