Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Pat... | NCT00294658

NCT00294658

ID	Type	Description	Link
1U01NS042685-01A2	U.S. NIH Grant/Contract		View source
CRC	Other Identifier	NINDS

Status Module

Sponsor/Collaborators Module

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Description Module

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thymectomy plus prednisone	Active Comparator	Procedure: Extended Transsternal Thymectomy plus prednisone treatment	Procedure: thymectomy plus prednisone
Prednisone alone	Placebo Comparator	Drug: prednisone alone protocol	Drug: prednisone alone

Name	Type	Description	Arm Group Labels	Other Names
thymectomy plus prednisone	Procedure	The thymectomy will be performed as soon as possible after randomization.	Thymectomy plus prednisone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years	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.	baseline, month 3, 4, 6 and every 3 months through 36 months
Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years	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.	baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months

Secondary Outcomes

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

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham, Department of Neurology, Sparks Center, Suite 350, 1720 7th Avenue South		Birmingham	Alabama	35233	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18675464	Result	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.
18567886	Result	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.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy had been performed as soon as possible after randomization.
FG001	Prednisone Alone

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Extended transsternal thymectomy plus prednisone

Drug: prednisone alone protocol

prednisone: Prednisone regimen had been taken every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
BG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00032(18 to 63) BG00133(18 to 64) BG00232(18 to 64)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00050 BG00139 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0006 BG0014 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00010 BG00111 BG002

Therapy at enrollment - Pyridostigimine

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00060 BG00156 BG002

Therapy at enrollment - Glucocorticoid

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00049 BG00147 BG002

Previous therapy - Intravenous immue globulin

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00012 BG00113 BG002

Previous therapy - Plasma exchange

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0009 BG0017 BG002

MGFA class

Class IIa. Predominantly affecting limb, axial muscles, or both. May also have lesser involvement of oropharyngeal muscles.

Class IIb. Predominantly affecting oropharyngeal, respiratory muscles, or both. May also have lesser or equal involvement of limb, axial muscles, or both.

Class III. Moderate weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.

Class IV. Severe weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.

Higher class was considered worse outcome.

Number

participants

Title

Denominators

Categories

IIa

Title	Measurements
	BG00025 BG001

Duration of disease

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG0001.08(0.02 to 4.41) BG0011.14(0.15 to 4.38) BG002

QMG score

Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39, with higher scores indicating more severe disease.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00011.40± 5.12 BG00112.35± 4.90

Prednisone use at baseline

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00049 BG00147 BG002

Prednisone Dosage at baseline (mg)

Prednisone dosage unit as mg, patient has been taken prednisone every other day

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00043.43± 28.92 BG00142.49± 23.52

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years

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.

Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.

Posted

Mean

Standard Deviation

units on a scale

baseline, month 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG00062 OG00156

Title

Denominators

Categories

Title	Measurements
	OG0006.15± 4.09 OG0018.99± 4.93

Primary

Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years

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.

Posted

Mean

Standard Deviation

baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants

Secondary

Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment

Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.

Four participants in Thymectomy plus prednisone and 5 in Prednisone alone group did not provide information to enable the calculation of Time-weighted average Quantitative Myasthenia Gravis Score by prednisone use at enrollment over 3 years.

Posted

Mean

Standard Deviation

units on a scale

baseline, month 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants

Secondary

Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex

Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.

Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.

Posted

Mean

Standard Deviation

units on a scale

baseline, month 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants

Secondary

Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset

Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.

Four participants in each group did not provide the information to enable calculation of the time-weighted average Quantitative Myasthenia Gravis Weakness Score over 3 years. Another 2 participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the age at disease onset information.

Posted

Mean

Standard Deviation

units on a scale

baseline, month 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants

Secondary

Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment

Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 1 in Prednisone alone group did not provide prednisone use at enrollment information.

Posted

Mean

Standard Deviation

baseline, month 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts

Secondary

Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex

Posted

Mean

Standard Deviation

baseline, month 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants

Secondary

Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset

Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 2 in Thymectomy plus prednisone group and 4 in Prednisone alone group did not provide age at disease onset information.

Posted

Mean

Standard Deviation

baseline, month 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts

Secondary

Number of Serious Adverse Events

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)

Posted

Number

events

baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Number of Patients With at Least One Serious Adverse Events

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)

Posted

Number

participants

baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Classification of Serious Adverse Events

One participant might had experienced more than one serious adverse event.

Posted

Number

participants

baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Hospitalization for Exacerbation of Myasthenia Gravis

Number of participants who had hospitalized over 2 and 3 years

Posted

Number

participants

baseline to 2 years and baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Cumulative Number of Hospital Days

Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)

Posted

Mean

Standard Deviation

days

baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term

Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)

Posted

Number

events

baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)

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.

Four participants in each group did not provide the information to enable calculation of the time-weighted average prescribed alternate-day prednisone dose (mg) over 3 years.

Posted

Mean

Standard Deviation

baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants

Secondary

Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)

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.

Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.

Posted

Mean

Standard Deviation

baseline, month 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts

Secondary

Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)

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.

Posted

Mean

Standard Deviation

baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts

Secondary

Time-Weighted Average MG Activity of Daily Living (MG-ADL)

MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life.

Five participants in each group did not provide the information to enable calculation of the time-weighted average MG activity of daily life over 3 years.

Posted

Mean

Standard Deviation

units on a scale

baseline, month 4, 6 and every 3 months through 36 months

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Time-Weighted Average MG Activity of Daily Living (MG-ADL) at 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.

Participants were in and out at month 12, 24 and 36 visit.

Posted

Mean

Standard Deviation

units on a scale

Month 12, 24, and 36

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Azathioprine Use

Posted

Number

participants

baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Plasma Exchange Use

Posted

Number

participants

baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Intravenous Immunoglobulin Use

Posted

Number

participants

baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Minimal Manifestation (MM) Status at Month 12, 24 and 36

Number of participants who were in minimal manifestation status at month 12, 24 and 36.

Number analyzed: Thymectomy plus prednisone: n=61 (Month 12), 59 (Month 24) , and 58 (Month 36); Prednisone alone n=54 (Month 12), 53 (Month 24), and 51 (Month 36)

Posted

Number

participants

Month 12, 24 and 36

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Cumulative Days in Hospital for Myasthenia Gravis Exacerbation

Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60)

Posted

Mean

Standard Deviation

days

baseline to 2 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Cumulative Days in Hospital for Myasthenia Gravis Exacerbation

Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60)

Posted

Mean

Standard Deviation

days

baseline to 3 years

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Short Form-36 Standardized Physical Component

Range from 0 to 100, the higher the physical component value, the better the mental health.

Participants were in and out by visit.

Posted

Median

Full Range

units on a scale

Month 0, Month 12, Month 24 and Month 36

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Short Form-36 Standardized Mental Component

Range from 0 to 100, the higher the mental component value, the better the mental health.

Participants were in and out by visit.

Posted

Median

Full Range

units on a scale

Month 0, Month 12, Month 24 and Month 36

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Treatment Associated Complications (TAC)

Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit.

Participants were in and out by each visit.

Posted

Count of Participants

Participants

Month 0, 1, 2, 3, 4 then every 3 months through Month 36

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Secondary

Treatment Associated Symptoms (TAS)

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.

Patients were in and out by visit

Posted

Count of Participants

Participants

Month 0, 1, 2, 3, 4 then every 3 months through Month 36

ID	Title	Description
OG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.
OG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Thymectomy Plus Prednisone	Procedure: Extended Transsternal Thymectomy plus prednisone treatment thymectomy: The thymectomy will be performed as soon as possible after randomization.			25	66	55	66
EG001	Prednisone Alone	Drug: prednisone alone protocol prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.			33	60	48	60

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Deafness	Ear and labyrinth disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected60 at risk
Cardiac death	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Appendicitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Bronchitis bacterial	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0014 events3 affected60 at risk
Device related sepsis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Diverticulitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0014 events1 affected60 at risk
Gastroenteritis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Incision site cellulitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0002 events2 affected66 at risk EG0010 events0 affected60 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0002 events1 affected66 at risk EG0013 events3 affected60 at risk
Pyelonephritis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Septic shock	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 events1 affected66 at risk EG0010 events0 affected60 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Myasthenia gravis	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0007 events6 affected66 at risk EG00143 events22 affected60 at risk
Myasthenia gravis crisis	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0006 events4 affected66 at risk EG00113 events10 affected60 at risk
Phrenic nerve paralysis	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Renal impairment	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Diaphragm muscle weakness	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Eye operation	Surgical and medical procedures	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Supportive care	Surgical and medical procedures	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Thoracotomy	Surgical and medical procedures	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk
Thymectomy	Surgical and medical procedures	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0017 events7 affected60 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected60 at risk
Hypertensive crisis	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected60 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract	Eye disorders	MedDRA (12.0)	Non-systematic Assessment	EG00014 events4 affected66 at risk EG00120 events7 affected60 at risk
Glaucoma	Eye disorders	MedDRA (12.0)	Non-systematic Assessment	EG00022 events5 affected66 at risk EG0011 events1 affected60 at risk
Herpes zoster	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0006 events5 affected66 at risk EG0018 events4 affected60 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0002 events2 affected66 at risk EG0013 events3 affected60 at risk
Liver function test abnormal	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0002 events2 affected66 at risk EG0013 events3 affected60 at risk
Abnormal weight gain	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG000184 events32 affected66 at risk EG001141 events31 affected60 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG00041 events6 affected66 at risk EG00144 events9 affected60 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG00043 events15 affected66 at risk EG0019 events4 affected60 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0013 events3 affected60 at risk
Mental disorder	Psychiatric disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 events4 affected66 at risk EG0018 events5 affected60 at risk
Sleep disorder	Psychiatric disorders	MedDRA (12.0)	Non-systematic Assessment	EG00086 events25 affected66 at risk EG00167 events22 affected60 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG00058 events21 affected66 at risk EG00148 events24 affected60 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG00044 events11 affected66 at risk EG0012 events2 affected60 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG00053 events16 affected66 at risk EG00155 events16 affected60 at risk

Potential weakness of this trial include the single-blinded and pill count methodology.

Certain Agreements

ID	Term
D009157	Myasthenia Gravis
D013945	Thymoma

Ancestor Terms

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010257	Paraneoplastic Syndromes
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases
D020511	Neuromuscular Junction Diseases
D009468	Neuromuscular Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D013953	Thymus Neoplasms
D013899	Thoracic Neoplasms
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D013934	Thymectomy
D011241	Prednisone
D011239	Prednisolone

Ancestor Terms

ID	Term
D019616	Thoracic Surgical Procedures
D013514	Surgical Procedures, Operative
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011246	Pregnadienetriols