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Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myasthenia Gravis

Intervention: thymectomy (Procedure); prednisone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Gary Cutter, PhD, Principal Investigator, Affiliation: University of Alabama at Birmingham School of Public Health, Department of Biostatistics
Gil Wolfe, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center

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.

Clinical Details

Official title: A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Comparison of the prednisone treatment alone to thymectomy (ETTX) plus prednisone treatment, based on the clinical response to therapy measured over the 3 year trial period by the Area Under the Quantitative Myasthenia Gravis Weakness Score

Testing the difference of 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.

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. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female MG patients age greater than 18 and less than 65 years

- Onset of generalized MG within the last 5 years

- Positive serum anti-acetylcholine receptor binding antibodies (AchR Ab =/> 1. 00

nmol/L. AchRAb levels of 0. 50-0. 99 nmol/L will be acceptable if there is another confirmatory test for MG, including single-fiber EMG, repetitive nerve stimulation, or unequivocal edrophonium testing.)

- MGFA class II-IV at entry, using the MG Foundation of America (MGFA) classification,

while receiving optimal anti-cholinesterase treatment with or without oral prednisone Exclusion Criteria:

- Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would

not require the use of corticosteroids

- Myasthenic weakness requiring intubation (MGFA Class IV) in the prior month

- Immunosuppressive therapy other than corticosteroids in the preceding year

- Medically unfit for thymectomy

- Chest CT evidence of thymoma.

- Pregnancy or lactation; contraindications to the use of corticosteroids, unless

postmenopausal or surgically sterile. Women considering becoming pregnant during the period of the study are to be excluded.

- A serious concurrent medical, neurological or psychiatric condition that would

interfere with thymectomy or subsequent clinical assessments

- Current alternate day dose of prednisone > than 1. 5 mg/kg or 100 mg or the equivalent

daily doses (> 0. 75 mg/kg or 50 mg).

- Participation in another experimental clinical trial

- History of alcohol or drug abuse within the 2 years prior to randomization.

Locations and Contacts

Centro de Asistencia Docencia e Investigacion en Miastenia (CADIMI) Av. Forest 1146 - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

The Royal Melbourne Hospital, Dept of Neurology, Royal Melbourne Hospital, Victoria 3050, Australia

Hospital de Base do Distrito Federal, Brasilia CEP 71640 255, Brazil

Hospital De Clinicas Da Universidade Federal Do Parana, Curitiba 80060-900, Brazil

Federal University of Rio de Janeiro, Rio de Janeiro CEP 20520-053, Brazil

McGill University Health Center, Montreal H3G 1A4, Canada

Hospital Del Salvador, Departamento de Ciencias Neurológicas, Universidad de Chile, Salvador 95 Of 416, Providencia, Santiago, Chile

Heinrich-Heine-University Dusseldorf, Dusseldorf D-40225, Germany

Johannes Gutenberg-Universitat, Klinikum der Johannes Gutenberg-Universität, Klinik und Poliklinik für Neurologie, Langenbeckstr, Mainz 55101, Germany

University of Regensburg, Dept. of Neurology, Universitätsstr. 84, D, Regensburg 93043, Germany

Universitat Tubingen, Tubingen 72076, Germany

Catholic University, Universita Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, e, Rome, Italy

University of Rome, Rome 00189, Italy

Instituto Nacional de Ciencias Medicas y Nutricion, Tlalpan 14000, Mexico

Leiden University Medical Center, Leiden 2300 RC, Netherlands

Medical University of Warsaw, Warsaw 02 097, Poland

University of Cape Town, Division of Neurology E8-74, Groote Schuur Hospital,Observatory, Cape Town, South Africa

Shin Kong Wu Ho-Su Memorial Hospital, Taipei City 111, Taiwan

Ramathibodi Hospital Mahidol University, Bangkok 10400, Thailand

South Glasgow University Hospitals, Glasgow G51 4TF, United Kingdom

The Walton Centre for Neurology and Neurosurgery, Lower Lane, Fazakerley, Liverpool L9 7LJ, United Kingdom

King's College Hospital, London SE5 9RS, United Kingdom

University of Oxford, Dept of Clinical Neurology, University of Oxford, Radcliffe Infirmary, Oxford OX26HE, United Kingdom

Data Coordination Center: University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

University of British Columbia, Vancouver, British Columbia V6T 2B5, Canada

University of Southern California, Doheny Institute, Los Angeles, California 90033, United States

University of California Irvine, 101 The City Drive S, Bldg. 22 C, Route 13, Orange, California 92868, United States

University of Florida Jacksonville, Tower I, 8th Floor, 580 W. 8th ST., Jacksonville, Florida 32209, United States

University of Miami, 1120 NW 14th Street, Suite 1300, Miami, Florida 33136, United States

Medical College of Georgia, Augusta, Georgia 30912, United States

Indiana University, Dept of Neurology, Regenstrief Health Center, 6th floor, 1050 Walnut St, Indiana University Medical Center, Indianapolis, Indiana 46202-2859, United States

Kanazawa University, Department of Neurology, Kanazawa University Hospital, 13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan

The University of Kansas Medical Center, Kansas City, Kansas 66160, United States

Brigham and Women's Hospital, 75 Francis Street, 5th Floor Tower, Boston, Massachusetts 02115-6110, United States

Wayne State University School of Medicine, 4201 St Antoine, 8D UHC, Detroit, Michigan 48201, United States

Mayo Clinic Rochester, Rochester, Minnesota 55905, United States

St. Louis University, St. Louis, Missouri 63103-2097, United States

Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901, United States

Mt. Sinai School of Medicine, New York, New York 10029, United States

University of Rochester Medical Center, Rochester, New York 14642, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Case Western Reserve University, University Hospitals of Cleveland, 1100 Euclid Avenue, Cleveland, Ohio 44106, United States

The Ohio State University Medical Center, Rm 461 Means Hall, The Ohio State University Medical Center,1654 Upham Dr., Columbus, Ohio 43210, United States

University of Texas Southwestern Medical Center, 5232 Harry Hines Blvd,, Dallas, Texas 75390-8897, United States

Nerve and Muscle Center of Texas, Houston, Texas 77030, United States

University of Texas Health Science Center, Mail code 7883, 7703 Floyd Curl Drive, San Antonio, Texas 78229-3900, United States

University of Vermont College of Medicine, Given Bldg C225, 89 Beaumont Avenue, Burlington, Vermont 05405, United States

University of Virginia, Charlottesville, Virginia 22908, United States

University of Washington, Seattle, Washington 98195, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: June 2006
Last updated: June 17, 2015

Page last updated: August 23, 2015

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