Trial · NCT00294658
Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy
NCT00294658, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2017-01-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy. Trials, record NCT00294658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00294658
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy
- NCT number
- NCT00294658
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 126 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Myasthenia Gravis
- Interventions
- thymectomy plus prednisone, prednisone alone
- First posted
- 2006-02-22
- Last updated
- 2017-05-23
- Results first posted
- 2017-01-16
- Limitations and caveats
- Potential weakness of this trial include the single-blinded and pill count methodology.
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years | 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. |
| Primary | Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years | 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 | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | 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. |
| Secondary | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex | 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. |
| Secondary | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset | 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. |
| Secondary | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment | 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. |
| Secondary | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex | 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. |
| Secondary | Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset | 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. |
| Secondary | Number of Serious Adverse Events | 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) |
| Secondary | Number of Patients With at Least One Serious Adverse Events | 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) |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years | baseline, month 3, 4, 6 and every 3 months through 36 months | 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. | units on a scale | MEAN |
| PRIMARY | Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years | baseline, month 1 , 2 , 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 time-weighted average alternate-day prednisone dose (mg) over 3 years. | mg | MEAN |
| SECONDARY | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | baseline, month 3, 4, 6 and every 3 months through 36 months | 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. | units on a scale | MEAN |
| SECONDARY | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex | baseline, month 3, 4, 6 and every 3 months through 36 months | 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. | units on a scale | MEAN |
| SECONDARY | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset | baseline, month 3, 4, 6 and every 3 months through 36 months | 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. | units on a scale | MEAN |
| SECONDARY | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment | 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 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. | mg | MEAN |
| SECONDARY | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex | 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 time-weighted average alternate-day prednisone dose (mg) over 3 years. | mg | MEAN |
| SECONDARY | Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset | 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 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. | mg | MEAN |
| SECONDARY | Number of Serious Adverse Events | baseline to 3 years | events | NUMBER | |
| SECONDARY | Number of Patients With at Least One Serious Adverse Events | baseline to 3 years | participants | NUMBER |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group178
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years | Thymectomy Plus Prednisone | 6.15 | Standard Deviation 4.09 | units on a scale | |
| Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years | Prednisone Alone | 8.99 | Standard Deviation 4.93 | units on a scale | |
| Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years | Thymectomy Plus Prednisone | 32 | Standard Deviation 23 | mg | |
| Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years | Prednisone Alone | 54 | Standard Deviation 29 | mg | |
| Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | Thymectomy Plus Prednisone | Not prednisone naïve | 6.30 | Standard Deviation 3.89 | units on a scale |
| Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | Prednisone Alone | Not prednisone naïve | 9.10 | Standard Deviation 5.06 | units on a scale |
| Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | Thymectomy Plus Prednisone | Prednisone naïve | 5.66 | Standard Deviation 4.79 | units on a scale |
| Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | Prednisone Alone | Prednisone naïve | 8.84 | Standard Deviation 4.60 | units on a scale |
| Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex | Thymectomy Plus Prednisone | Female | 6.47 | Standard Deviation 4.13 | units on a scale |
| Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex | Prednisone Alone | Female | 9.73 | Standard Deviation 5.16 | units on a scale |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Thymectomy Plus Prednisone | 66 | |
| Overall Study | STARTED | Prednisone Alone | 60 | |
| Overall Study | COMPLETED | Thymectomy Plus Prednisone | 60 | |
| Overall Study | COMPLETED | Prednisone Alone | 51 | |
| Overall Study | NOT COMPLETED | Thymectomy Plus Prednisone | 6 | |
| Overall Study | NOT COMPLETED | Prednisone Alone | 9 |
Source ClinicalTrials.gov
Adverse events138
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract | Eye disorders | Thymectomy Plus Prednisone | 4 | 66 | 14 |
| other | Cataract | Eye disorders | Prednisone Alone | 7 | 60 | 20 |
| other | Glaucoma | Eye disorders | Thymectomy Plus Prednisone | 5 | 66 | 22 |
| other | Glaucoma | Eye disorders | Prednisone Alone | 1 | 60 | 1 |
| other | Herpes zoster | Infections and infestations | Thymectomy Plus Prednisone | 5 | 66 | 6 |
| other | Herpes zoster | Infections and infestations | Prednisone Alone | 4 | 60 | 8 |
| other | Tendon rupture | Injury, poisoning and procedural complications | Thymectomy Plus Prednisone | 2 | 66 | 2 |
| other | Tendon rupture | Injury, poisoning and procedural complications | Prednisone Alone | 3 | 60 | 3 |
| other | Liver function test abnormal | Investigations | Thymectomy Plus Prednisone | 2 | 66 | 2 |
| other | Liver function test abnormal | Investigations | Prednisone Alone | 3 | 60 | 3 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thymectomy Plus Prednisone | ||
| Total, all-cause mortality | Prednisone Alone | ||
| Total, other adverse events | Thymectomy Plus Prednisone | 55 | 66 |
| Total, other adverse events | Prednisone Alone | 48 | 60 |
| Total, serious adverse events | Thymectomy Plus Prednisone | 25 | 66 |
| Total, serious adverse events | Prednisone Alone | 33 | 60 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01NS042685 | Thymectomy in Non-Thymomatous MG Patients on Prednisone | CUTTER, GARY R | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2005 to 2015 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Thymectomy Plus Prednisone vs Prednisone Alone: Azathioprine Use | Trial comparisons |
| Thymectomy Plus Prednisone vs Prednisone Alone: Intravenous Immunoglobulin Use | Trial comparisons |
| Thymectomy Plus Prednisone vs Prednisone Alone: Number of Patients With at Least One Serious Adverse Events | Trial comparisons |
| Thymectomy Plus Prednisone vs Prednisone Alone: Plasma Exchange Use | Trial comparisons |
| Thymectomy Plus Prednisone vs Prednisone Alone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00294658
GET https://conductscience.org/api/trials/v1/NCT00294658/registered?page=2