Clinical Trial Results:
Prospective Randomized Clinical Trial of Total Thyroidectomy (Tx) versus Thionamides (Anti-Thyroid Drugs) in Patients with Moderate-to-Severe Graves’ Ophthalmopathy - a 1-year Follow-up
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Summary
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EudraCT number |
2015-003515-38 |
Trial protocol |
AT |
Global end of trial date |
17 Nov 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Mar 2023
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First version publication date |
28 Mar 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GO-TXATD
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Medical University Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Dr. Lindsay Hargitai, Medical University Vienna, 43 14040056210, lindsay.hargitai@meduniwien.ac.at
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Scientific contact |
Dr. Lindsay Hargitai, Medical University Vienna, 43 14040056210, lindsay.hargitai@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Jan 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Nov 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Nov 2022
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse following the initial decrease in ATD after 6 months. Establish a glucocorticoid scheme before and after Tx in patients with moderate-to-severe EO.
The difference will primarily be measured in terms of the Muscle Index score determined through an ultrasound.
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Protection of trial subjects |
All patients signed a declaration of consent were safety measures were previously discussed. All patients underwent in long term follow-up with blood analyses.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 14
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Worldwide total number of subjects |
14
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EEA total number of subjects |
14
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
14
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
Screening criteria were required for each patient | |||||||||
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Period 1
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Period 1 title |
Study period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Carer [1] | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Thyroidectomy | |||||||||
Arm description |
- | |||||||||
Arm type |
Surgery | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Anti-thyroid drug (ATD) | |||||||||
Arm description |
- | |||||||||
Arm type |
Antithyroid drug medicine | |||||||||
Investigational medicinal product name |
Anti-thyroid drug (ATD)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Oral usage, dosage based on hormone levels in the blood
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| Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: Yes |
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| Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Too few patients were enrolled in this study and therefore the study was discontinued. |
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Baseline characteristics reporting groups
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Reporting group title |
Study period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Thyroidectomy
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Reporting group description |
- | ||
Reporting group title |
Anti-thyroid drug (ATD)
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Reporting group description |
- | ||
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End point title |
Thyroid antibodies [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 year
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Too few patients |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
CAScore [2] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 year
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Too few patients |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Quality of Life Score [3] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 year
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Too few patients |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Study period
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
25
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events were reported within the whole trial |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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05 Oct 2019 |
Change principal investigators, change last name of study coordinator |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
