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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00294658
First Posted: February 22, 2006
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Gary Cutter, PhD, University of Alabama at Birmingham
  Purpose
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.

Condition Intervention Phase
Myasthenia Gravis Procedure: thymectomy plus prednisone Drug: prednisone alone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone

Resource links provided by NLM:


Further study details as provided by Gary Cutter, PhD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years [ Time Frame: baseline, month 3, 4, 6 and every 3 months through 36 months ]
    Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method where in the QMG score is multiplied by the number of days at this level from one visit to the next and added up over the entire followup experience and divided by the total number of days from randomization.

  • Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years [ Time Frame: baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months ]
    Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.


Secondary Outcome Measures:
  • Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment [ Time Frame: baseline, month 3, 4, 6 and every 3 months through 36 months ]
    Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.

  • Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex [ Time Frame: baseline, month 3, 4, 6 and every 3 months through 36 months ]
    Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.

  • Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset [ Time Frame: baseline, month 3, 4, 6 and every 3 months through 36 months ]
    Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.

  • Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment [ Time Frame: baseline, month 3, 4, 6 and every 3 months through 36 months ]
    Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.

  • Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex [ Time Frame: baseline, month 3, 4, 6 and every 3 months through 36 months ]
    Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.

  • Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset [ Time Frame: baseline, month 3, 4, 6 and every 3 months through 36 months ]
    Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.

  • Number of Serious Adverse Events [ Time Frame: baseline to 3 years ]
    Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)

  • Number of Patients With at Least One Serious Adverse Events [ Time Frame: baseline to 3 years ]
    Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)

  • Classification of Serious Adverse Events [ Time Frame: baseline to 3 years ]
  • Hospitalization for Exacerbation of Myasthenia Gravis [ Time Frame: baseline to 2 years and baseline to 3 years ]
  • Cumulative Number of Hospital Days [ Time Frame: baseline to 3 years ]
    Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)

  • Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term [ Time Frame: baseline to 3 years ]
    Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)

  • Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg) [ Time Frame: baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months ]
    Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period.

  • Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine) [ Time Frame: baseline, month 3, 4, 6 and every 3 months through 36 months ]
    For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.

  • Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine) [ Time Frame: baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months ]
    For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.

  • Time-Weighted Average MG Activity of Daily Living (MG-ADL) [ Time Frame: baseline, month 4, 6 and every 3 months through 36 months ]
    MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life.

  • Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36 [ Time Frame: Month 12, 24, and 36 ]
    MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life.

  • Azathioprine Use [ Time Frame: baseline to 3 years ]
  • Plasma Exchange Use [ Time Frame: baseline to 3 years ]
  • Intravenous Immunoglobulin Use [ Time Frame: baseline to 3 years ]
  • Minimal Manifestation (MM) Status at Month 12, 24 and 36 [ Time Frame: Month 12, 24 and 36 ]
    Number of participants who were in minimal manifestation status at month 12, 24 and 36.

  • Cumulative Days in Hospital for Myasthenia Gravis Exacerbation [ Time Frame: baseline to 2 years ]
    Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60)

  • Cumulative Days in Hospital for Myasthenia Gravis Exacerbation [ Time Frame: baseline to 3 years ]
    Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60)

  • Short Form-36 Standardized Physical Component [ Time Frame: Month 0, Month 12, Month 24 and Month 36 ]
    Range from 0 to 100, the higher the physical component value, the better the mental health.

  • Short Form-36 Standardized Mental Component [ Time Frame: Month 0, Month 12, Month 24 and Month 36 ]
    Range from 0 to 100, the higher the mental component value, the better the mental health.

  • Treatment Associated Complications (TAC) [ Time Frame: Month 0, 1, 2, 3, 4 then every 3 months through Month 36 ]
    Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit.

  • Treatment Associated Symptoms (TAS) [ Time Frame: Month 0, 1, 2, 3, 4 then every 3 months through Month 36 ]
    Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit.


Enrollment: 126
Study Start Date: June 2006
Study Completion Date: December 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thymectomy plus prednisone
Procedure: Extended Transsternal Thymectomy plus prednisone treatment
Procedure: thymectomy plus prednisone
The thymectomy will be performed as soon as possible after randomization.
Other Name: Extended transsternal thymectomy plus prednisone
Placebo Comparator: Prednisone alone
Drug: prednisone alone protocol
Drug: prednisone alone
Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.
Other Name: prednisolone

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (muscle acetylcholine receptors, AchRAb =/> 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 electromyography (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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294658


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham, Department of Neurology, Sparks Center, Suite 350, 1720 7th Avenue South
Birmingham, Alabama, United States, 35233
Data Coordination Center: University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Barrow Neurological Institute, Saint Joseph's Hospital and Medical Center, 350 W Thomas Rd
Phoenix, Arizona, United States, 85016
United States, California
University of Southern California, Doheny Institute, 1450 San Pablo St
Los Angeles, California, United States, 90033
University of California Irvine, 101 The City Drive S, Bldg. 22 C, Route 13
Orange, California, United States, 92868
California Pacific Medical Center, Castro St & Duboce Ave
San Francisco, California, United States, 94114
United States, Florida
University of Florida Jacksonville, Tower I, 8th Floor, 580 W. 8th ST.
Jacksonville, Florida, United States, 32209
University of Miami, 1120 NW 14th Street, Suite 1300
Miami, Florida, United States, 33136
United States, Georgia
Emory University, 201 Dowman Dr
Atlanta, Georgia, United States, 30322
Augusta University, 1120 15th St
Augusta, Georgia, United States, 30912
United States, Indiana
Indiana University, Dept of Neurology, Regenstrief Health Center, 6th floor, 1050 Walnut St, Indiana University Medical Center
Indianapolis, Indiana, United States, 46202-2859
United States, Kansas
The University of Kansas Medical Center, 3901 Rainbow Blvd.
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Brigham and Women's Hospital, 75 Francis Street, 5th Floor Tower
Boston, Massachusetts, United States, 02115-6110
United States, Michigan
Wayne State University School of Medicine, 4201 St Antoine, 8D UHC
Detroit, Michigan, United States, 48201
William Beaumont Hospital, 3601 W. Thirteen Mile Road, Royal Oak
Royal Oak, Michigan, United States, 48073
United States, Minnesota
University of Minnesota, Department of Neurology, MMC 295, 420 Delaware St. S.E.,
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Rochester, 200 First St. SW
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis University, One North Grand St. Louis
St. Louis, Missouri, United States, 63103-2097
United States, New Jersey
Robert Wood Johnson University,
New Brunswick, New Jersey, United States, 08901
United States, New York
Mount Sinai Hospital,1 Gustave L. Levy Pl
New York, New York, United States, 10029
University of Rochester, 601 Elmwood Ave
Rochester, New York, United States, 14642
United States, North Carolina
Duke University, 200 Trent Dr
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western Reserve University, University Hospitals of Cleveland, 1100 Euclid Avenue
Cleveland, Ohio, United States, 44106
The Ohio State University Wexmer Medical Center, Rm 461 Means Hall, The Ohio State University Medical Center,1654 Upham Dr.
Columbus, Ohio, United States, 43210
United States, Texas
University of Texas Southwestern Medical Center, 5232 Harry Hines Blvd,
Dallas, Texas, United States, 75390-8897
University of Texas Medical Branch, 301 University Blvd
Galveston, Texas, United States, 77555-0539
Nerve and Muscle Center of Texas, 6624 Fannin St # 1670
Houston, Texas, United States, 77030
University of Texas Health Science Center, Mail code 7883, 7703 Floyd Curl Drive
San Antonio, Texas, United States, 78229-3900
United States, Vermont
University of Vermont College of Medicine, Given Bldg C225, 89 Beaumont Avenue
Burlington, Vermont, United States, 05405
United States, Virginia
University of Virginia, 1215 Lee St
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington, 1410 NE Campus Pkwy
Seattle, Washington, United States, 98195
United States, West Virginia
West Virginia University, Dept of Neurology, WVU Eye Institute, Neurology Suite, 1 Stadium Drive,
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Medical College of Wisconsin, 8701 Watertown Plank Road
Milwaukee, Wisconsin, United States, 53226
Argentina
University of Buenis, Centro de Asistencia Docencia e Investigacion en Miastenia (CADIMI) Av. Forest 1146 - Ciudad Autonoma de Buenos Aires
Buenos Aires, Argentina
Australia
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, 3050
Brazil
Hospital de Base do Distrito Federal
Brasilia, Brazil, CEP 71640 255
Universidade Federal do Parana
Curitiba, Brazil, 80060-900
Federal University of Rio De Janeiro
Rio De Janeiro, Brazil, CEP 20520-053
Canada, Alberta
University of Calgary, Heritage Medical Research Clinic Room 1132 3330 Hospital Dr NW
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
University of Ottawa, The Ottawa Hospital General Campus, Division of Neurology, 501 Smyth Rd. Box 601
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Chile
Hospital Del Salvador, Departamento de Ciencias Neurológicas, Universidad de Chile, Salvador 95 Of 416, Providencia
Santiago, Chile
Germany
University of Heidelberg, Seminarstraße 2
Mannheim, Baden-Württemberg, Germany, 69117
University of Regensburg, Dept. of Neurology, Universitätsstr. 84, D
Regensburg, Bavaria, Germany, 93043
University of Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, D-40225
Johannes-Gutenberg University, Klinikum der Johannes Gutenberg-Universität, Klinik und Poliklinik für Neurologie, Langenbeckstr
Mainz, Rhineland-Palatinate, Germany, 55101
University of Münster, Schlossplatz 2
Münster, Germany, 48149
University of Tübingen
Tübingen, Germany, 72076
Italy
National Neurological Institute "Carlo Besta", Myopathology and Immunology Unit, Dept of Neurology IV, Natl. Neurolog Inst. "C. Besta", Via Celoria, 11,
Milan, Italy, 20133
University of Rome "Sapienza"
Rome, Italy, 00189
Catholic University, Universita Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, e
Rome, Italy
University of Torino
Torino, Italy
Japan
Kanazawa University, Department of Neurology, Kanazawa University Hospital, 13-1 Takaramachi
Kanazawa, Ishikawa, Japan, 920-8641
Nagasaki University, First Department of Internal Medicine,Graduate School of Biomedical Sciences,1-7-1,Sakamoto
Nagasaki, Kyushu, Japan, 852-8501
Mexico
Instituto Nacional de la Nutrición
Mexico, Mexico, 14000
Netherlands
Leiden University
Leiden, Netherlands
Poland
Medical University of Warsaw
Warsaw, Województwo, Poland, 02 097
Institute of Tuberculosis and Lung Disease
Warsaw, Województwo, Poland
Portugal
Porto University, Serviço de Neurologia,Hospital Geral de Santo António, Largo Prof Abel Salazar
Porto, Portugal, 4099-001
South Africa
University of Cape Town, Division of Neurology E8-74, Groote Schuur Hospital,Observatory
Cape Town, South Africa
Spain
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, 08025
Taiwan
Fu-Jen Catholic University, No. 510, Zhongzheng Rd., Xinzhuang Dist
New Taipei, Taiwan, 24205
Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
United Kingdom
Queen Elizabeth University Hospital, Glasgow
Glasgow, United Kingdom, G51 4TF
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, L9 7LJ
University of Manchester, Oxford Road
Manchester, United Kingdom, M13 9PL
University of Oxford, Dept of Clinical Neurology, University of Oxford, Radcliffe Infirmary
Oxford, United Kingdom, OX2 6HE
University of Sheffield, Western Bank
Sheffield, United Kingdom, S10 2TN
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Gary Cutter, PhD University of Alabama at Birmingham School of Public Health, Department of Biostatistics
Principal Investigator: Gil Wolfe, MD University of Buffalo, Jacobs School of Medicine and Biomedical Sciences
Principal Investigator: Henry Kaminski, MD George Washington University School of Medicine and Health Sciences
  More Information

Publications:
Aban IB, Wolfe GI, Cutter GR, Kaminski HJ, Jaretzki A 3rd, Minisman G, Conwit R, Newsom-Davis J; Mgtx Advisory Committee. The MGTX experience: challenges in planning and executing an international, multicenter clinical trial. J Neuroimmunol. 2008 Sep 15;201-202:80-4. doi: 10.1016/j.jneuroim.2008.05.031. Erratum in: J Neuroimmunol. 2009 Dec 10;217(1-2):103.
Newsom-Davis J, Cutter G, Wolfe GI, Kaminski HJ, Jaretzki A 3rd, Minisman G, Aban I, Conwit R. Status of the thymectomy trial for nonthymomatous myasthenia gravis patients receiving prednisone. Ann N Y Acad Sci. 2008;1132:344-7. doi: 10.1196/annals.1405.014.
Minisman G, Bhanushali M, Conwit R, Wolfe GI, Aban I, Kaminski HJ, Cutter G. Implementing clinical trials on an international platform: challenges and perspectives. J Neurol Sci. 2012 Feb 15;313(1-2):1-6. doi: 10.1016/j.jns.2011.10.004. Epub 2011 Nov 1. Review.
Kaminski HJ, Kusner LL, Wolfe GI, Aban I, Minisman G, Conwit R, Cutter G. Biomarker development for myasthenia gravis. Ann N Y Acad Sci. 2012 Dec;1275:101-6. doi: 10.1111/j.1749-6632.2012.06787.x. Review.
Wolfe GI, Kaminski HJ, Aban IB, Minisman G, Kuo HC, Marx A, Ströbel P, Mazia C, Oger J, Cea JG, Heckmann JM, Evoli A, Nix W, Ciafaloni E, Antonini G, Witoonpanich R, King JO, Beydoun SR, Chalk CH, Barboi AC, Amato AA, Shaibani AI, Katirji B, Lecky BR, Buckley C, Vincent A, Dias-Tosta E, Yoshikawa H, Waddington-Cruz M, Pulley MT, Rivner MH, Kostera-Pruszczyk A, Pascuzzi RM, Jackson CE, Garcia Ramos GS, Verschuuren JJ, Massey JM, Kissel JT, Werneck LC, Benatar M, Barohn RJ, Tandan R, Mozaffar T, Conwit R, Odenkirchen J, Sonett JR, Jaretzki A 3rd, Newsom-Davis J, Cutter GR; MGTX Study Group. Randomized Trial of Thymectomy in Myasthenia Gravis. N Engl J Med. 2016 Aug 11;375(6):511-22. doi: 10.1056/NEJMoa1602489. Erratum in: N Engl J Med. 2017 May 25;376(21):2097. [Dosage error in article text].

Responsible Party: Gary Cutter, PhD, Principle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00294658     History of Changes
Other Study ID Numbers: R01NS050733
1U01NS042685-01A2 ( U.S. NIH Grant/Contract )
CRC ( Other Identifier: NINDS )
First Submitted: February 21, 2006
First Posted: February 22, 2006
Results First Submitted: September 19, 2016
Results First Posted: January 16, 2017
Last Update Posted: May 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Gary Cutter, PhD, University of Alabama at Birmingham:
myasthenia gravis
thymectomy
prednisone
corticosteroid
extended transsternal thymectomy
ETTX
MG
thymus
thymoma

Additional relevant MeSH terms:
Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents


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