Spots Global Cancer Trial Database for Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy
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Trial Identification
Brief Title: Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy
Official Title: A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone
Study ID: NCT00294658
Conditions
Study Description
Brief Summary: The purpose of this trial is to determine if thymectomy combined with prednisone therapy is more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.
Detailed Description: Myasthenia gravis (MG) is an autoimmune disease involving the thymus in which 85 percent of patients have antibodies to muscle acetylcholine receptors (AchR-Ab) that interfere with neuromuscular transmission. MG frequently causes severe disability that can be life-threatening. Thymectomy-a surgical procedure that removes thymus gland tissue from the chest cavity-has been an established therapy for non-thymomatous MG, or MG without thymoma, for more than 60 years (based on retrospective, non-randomized studies). Corticosteroids are now being used increasingly either as the sole treatment or in combination with thymectomy. Both therapies have associated adverse effects and indications for their use based on randomized trial data are lacking. The purpose of this 5-year trial is to determine if the surgical procedure, extended transsternal thymectomy (ETTX), combined with prednisone therapy is more beneficial in treating individuals with non-thymomatous MG than prednisone therapy alone. More specifically, this study will determine 1) if ETTX combined with prednisone results in a greater improvement in myasthenic weakness, compared to prednisone alone; 2) if ETTX combined with prednisone results in a lower total dose of prednisone, thus decreasing the likelihood of concurrent and long-term toxic effects, compared to prednisone alone; and 3) if ETTX combined with prednisone enhances quality of life by reducing adverse events and symptoms associated with the therapies, compared to prednisone alone. Learning that thymectomy results in a meaningful reduction of prednisone dosage or even full withdrawal or reduces side effects related to prednisone would support using the two treatments-thymectomy and prednisone-together. However, if no meaningful reduction of prednisone dosage or side effects is shown, the results would mean that using the two treatments together offers no advantages over prednisone treatment alone. After an initial screening, study participants will be randomized either to undergo the surgical procedure ETTX and receive prednisone treatment, or to receive prednisone treatment alone without surgery. Participants will be followed for at least 3 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Department of Neurology, Sparks Center, Suite 350, 1720 7th Avenue South, Birmingham, Alabama, United States
Data Coordination Center: University of Alabama at Birmingham, Birmingham, Alabama, United States
Barrow Neurological Institute, Saint Joseph's Hospital and Medical Center, 350 W Thomas Rd, Phoenix, Arizona, United States
University of Southern California, Doheny Institute, 1450 San Pablo St, Los Angeles, California, United States
University of California Irvine, 101 The City Drive S, Bldg. 22 C, Route 13, Orange, California, United States
California Pacific Medical Center, Castro St & Duboce Ave, San Francisco, California, United States
University of Florida Jacksonville, Tower I, 8th Floor, 580 W. 8th ST., Jacksonville, Florida, United States
University of Miami, 1120 NW 14th Street, Suite 1300, Miami, Florida, United States
Emory University, 201 Dowman Dr, Atlanta, Georgia, United States
Augusta University, 1120 15th St, Augusta, Georgia, United States
Indiana University, Dept of Neurology, Regenstrief Health Center, 6th floor, 1050 Walnut St, Indiana University Medical Center, Indianapolis, Indiana, United States
The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, Kansas, United States
Brigham and Women's Hospital, 75 Francis Street, 5th Floor Tower, Boston, Massachusetts, United States
Wayne State University School of Medicine, 4201 St Antoine, 8D UHC, Detroit, Michigan, United States
William Beaumont Hospital, 3601 W. Thirteen Mile Road, Royal Oak, Royal Oak, Michigan, United States
University of Minnesota, Department of Neurology, MMC 295, 420 Delaware St. S.E.,, Minneapolis, Minnesota, United States
Mayo Clinic Rochester, 200 First St. SW, Rochester, Minnesota, United States
St. Louis University, One North Grand St. Louis, St. Louis, Missouri, United States
Robert Wood Johnson University,, New Brunswick, New Jersey, United States
Mount Sinai Hospital,1 Gustave L. Levy Pl, New York, New York, United States
University of Rochester, 601 Elmwood Ave, Rochester, New York, United States
Duke University, 200 Trent Dr, Durham, North Carolina, United States
Case Western Reserve University, University Hospitals of Cleveland, 1100 Euclid Avenue, Cleveland, Ohio, United States
The Ohio State University Wexmer Medical Center, Rm 461 Means Hall, The Ohio State University Medical Center,1654 Upham Dr., Columbus, Ohio, United States
University of Texas Southwestern Medical Center, 5232 Harry Hines Blvd,, Dallas, Texas, United States
University of Texas Medical Branch, 301 University Blvd, Galveston, Texas, United States
Nerve and Muscle Center of Texas, 6624 Fannin St # 1670, Houston, Texas, United States
University of Texas Health Science Center, Mail code 7883, 7703 Floyd Curl Drive, San Antonio, Texas, United States
University of Vermont College of Medicine, Given Bldg C225, 89 Beaumont Avenue, Burlington, Vermont, United States
University of Virginia, 1215 Lee St, Charlottesville, Virginia, United States
University of Washington, 1410 NE Campus Pkwy, Seattle, Washington, United States
West Virginia University, Dept of Neurology, WVU Eye Institute, Neurology Suite, 1 Stadium Drive,, Morgantown, West Virginia, United States
Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, Wisconsin, United States
University of Buenis, Centro de Asistencia Docencia e Investigacion en Miastenia (CADIMI) Av. Forest 1146 - Ciudad Autonoma de Buenos Aires, Buenos Aires, , Argentina
University of Sydney, Royal Prince Alfred Hospital and The University of Sydney, Sydney, , Australia
University of Melbourne, Melbourne, The Royal Melbourne Hospital, Dept of Neurology, Royal Melbourne Hospital, Victoria, , Australia
Hospital de Base do Distrito Federal, Brasilia, , Brazil
Universidade Federal do Parana, Curitiba, , Brazil
Federal University of Rio De Janeiro, Rio De Janeiro, , Brazil
University of Calgary, Heritage Medical Research Clinic Room 1132 3330 Hospital Dr NW, Calgary, Alberta, Canada
University of British Columbia, Vancouver, British Columbia, Canada
University of Ottawa, The Ottawa Hospital General Campus, Division of Neurology, 501 Smyth Rd. Box 601, Ottawa, Ontario, Canada
McGill University Health Center, Montreal, Quebec, Canada
Hospital Del Salvador, Departamento de Ciencias Neurológicas, Universidad de Chile, Salvador 95 Of 416, Providencia, Santiago, , Chile
University of Heidelberg, Seminarstraße 2, Mannheim, Baden-Württemberg, Germany
University of Regensburg, Dept. of Neurology, Universitätsstr. 84, D, Regensburg, Bavaria, Germany
University of Düsseldorf, Düsseldorf, North Rhine-Westphalia, Germany
Johannes-Gutenberg University, Klinikum der Johannes Gutenberg-Universität, Klinik und Poliklinik für Neurologie, Langenbeckstr, Mainz, Rhineland-Palatinate, Germany
University of Münster, Schlossplatz 2, Münster, , Germany
University of Tübingen, Tübingen, , Germany
National Neurological Institute "Carlo Besta", Myopathology and Immunology Unit, Dept of Neurology IV, Natl. Neurolog Inst. "C. Besta", Via Celoria, 11,, Milan, , Italy
University of Rome "Sapienza", Rome, , Italy
Catholic University, Universita Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, e, Rome, , Italy
University of Torino, Torino, , Italy
Kanazawa University, Department of Neurology, Kanazawa University Hospital, 13-1 Takaramachi, Kanazawa, Ishikawa, Japan
Nagasaki University, First Department of Internal Medicine,Graduate School of Biomedical Sciences,1-7-1,Sakamoto, Nagasaki, Kyushu, Japan
Instituto Nacional de la Nutrición, Mexico, , Mexico
Leiden University, Leiden, , Netherlands
Medical University of Warsaw, Warsaw, Województwo, Poland
Institute of Tuberculosis and Lung Disease, Warsaw, Województwo, Poland
Porto University, Serviço de Neurologia,Hospital Geral de Santo António, Largo Prof Abel Salazar, Porto, , Portugal
University of Cape Town, Division of Neurology E8-74, Groote Schuur Hospital,Observatory, Cape Town, , South Africa
H. Sant Pau, Universitat Autònoma de Barcelona, Neurology Department, Hospital Sta Creu i Sant Pau, C/Mas Casanovas no 90 4o pis 4o modul., Barcelona, , Spain
Fu-Jen Catholic University, No. 510, Zhongzheng Rd., Xinzhuang Dist, New Taipei, , Taiwan
Ramathibodi Hospital, Mahidol University, Bangkok, , Thailand
Queen Elizabeth University Hospital, Glasgow, Glasgow, , United Kingdom
Walton Centre for Neurology and Neurosurgery, Liverpool Heart and Chest Hospital, Liverpool. The Walton Centre for Neurology and Neurosurgery, Lower Lane, Fazakerley, Liverpool, , United Kingdom
University of Manchester, Oxford Road, Manchester, , United Kingdom
University of Oxford, Dept of Clinical Neurology, University of Oxford, Radcliffe Infirmary, Oxford, , United Kingdom
University of Sheffield, Western Bank, Sheffield, , United Kingdom
Contact Details
Name: Gary Cutter, PhD
Affiliation: University of Alabama at Birmingham School of Public Health, Department of Biostatistics
Role: PRINCIPAL_INVESTIGATOR
Name: Gil Wolfe, MD
Affiliation: University of Buffalo, Jacobs School of Medicine and Biomedical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Henry Kaminski, MD
Affiliation: George Washington University School of Medicine and Health Sciences
Role: PRINCIPAL_INVESTIGATOR
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