[International project--MGTX study].
MGTX Study is a multi-center, international, single-blinded, randomized trial to determine whether extended transsternal thymectomy (ETTX) for patients with myasthenia gravis receiving the prednisone protocol confers added benefits to the prednisone protocol alone. The aims of the study are answering following three questions. 1) Does ETTX combined with prednisone result in a greater improvement in myasthenic weakness, compared to prednisone alone? 2) Does ETTX combined with prednisone result in a lower total dose of prednisone, thus decreasing the likelihood of concurrent and long-term toxic effects, compared to prednisone alone? 3) Does ETTX combined with prednisone enhance quality of life by reducing adverse events and symptoms associated with the therapies, compared to prednisone alone? Primary outcome measure is consists with 1) Comparison of the prednisone protocol alone to prednisone protocol plus ETTX, based on the clinical response to therapy measured over the 3 year trial period by the Area Under the Quantitative Myasthenia Gravis (QMG) Weakness Score (AUQMG), and 2) Testing the difference in the total prednisone used over the 3 year trial period measured by pill count from blister packs (Area Under the Prednisone Dose Time Curve, AUDTC), conditional on the results of comparing AUQMG.
Yoshikawa
Hiroaki
H
Health Service Center, Kanazawa University.
D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D007391:International Cooperation; D009157:Myasthenia Gravis / Q000601:surgery*; D011241:Prednisone / Q000627:therapeutic use*; D016037:Single-Blind Method; D013934:Thymectomy
D005938:Glucocorticoids; D011241:Prednisone