Graves DiseasePhase 3NCT03066076
Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy
A Phase 3 study testing Antithyroid Drug and Total thyroidectomy in people with Graves Disease and Graves Ophthalmopathy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Graves Disease, Graves Ophthalmopathy, Graves' Ophthalmopathy Worsened
- What is being tested?
- Antithyroid Drug and Total thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2017to 1 Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GD and GO onset < 12 months
- no previous GD treatment other than antithyroid drugs (ATD)
- first relapse after decrease of antithyroid medication within 4-6 months
- GO treatment with glucocorticoids based on the Kahaly scheme
- patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO
- clinically active inflammation according to CAScore (>3/7)
- informed consent
Who cannot join
- GD and GO onset > 12 months
- more than one relapse of GO longer than 6 months from diagnosis
- previous GD treatment by RAI or surgery
- SNI greater than 7.0
- urgent orbital decompression surgery
- loss of vision
Show all 16Show fewer
- loss of visual field
- loss of color vision
- patients not receiving glucocorticoids for GO
- cytological findings of postsurgical histopathological results suspicious for malignancy
- pregnancy or breast-feeding
- contraindication to GC
- halt of GC therapy
- Patients with diabetes mellitus
- age below 18 years
- no informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Surgery and Department of Ophthalmology Medical University Vienna
Vienna, 1090
Lindsay Brammen, MD, +4314040056210, lindsay.brammen@meduniwien.ac.at
Philipp Riss, MD, +4314040056210, philipp.riss@meduniwien.ac.at
About this study
Official title: 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
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.
Objective: 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 of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.
Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
Read the detailed description
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.
Objective: 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 of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.
Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
- Being tested
- Antithyroid Drug, Total thyroidectomy
- Medical subject headings
- Graves Disease, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithyroid DrugDrug
Also called Thiamazol, Propylthiouracil
Antithyroid drug
Total thyroidectomyProcedure or surgery
Operation
| Study group | Role | What they receive |
|---|---|---|
| Thyroidectomy | Active comparator | Total thyroidectomy Receives: Drug: Antithyroid Drug |
| Antithyroid drug | Active comparator | Thiamazol, Propylthiouracil Receives: Procedure: Total thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle index (MI) from ultrasound measurements
Muscle index (MI) from ultrasound measurements
Measured: 12 months
Thyroid antibodies
Thyroid antibodies
Measured: 12 months
Secondary outcomes (3)
CAScore/NOSPECS score
CAScore/NOSPECS score
Measured: 12 months
Superonasal index measurements via ultrasound
Superonasal index measurements via ultrasound
Measured: 12 months
Quality of life score
Quality of life score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Riss, Medical University of Vienna
- Investigators
- Philipp Riss, MD, Principal investigator, Medical University of ViennaGuido Dorner, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066076
- Sponsor's protocol ID
- 1839/2015
- Other IDs
- 2015-003515-38, 2015
- Status last verified
- Feb 2017
- First submitted
- 27 Jan 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03066076
- Acronym / sponsor ID
- 1839/2015
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.
Objective: 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 of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.
Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
Detailed description
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.
Objective: 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 of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.
Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroidectomy | Active comparator | Drug: Antithyroid DrugTotal thyroidectomy |
| Antithyroid drug | Active comparator | Procedure: Total thyroidectomyThiamazol, Propylthiouracil |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- GD and GO onset < 12 months
- no previous GD treatment other than antithyroid drugs (ATD)
- first relapse after decrease of antithyroid medication within 4-6 months
- GO treatment with glucocorticoids based on the Kahaly scheme
- patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO
Key exclusion criteria (16 listed)
- GD and GO onset > 12 months
- more than one relapse of GO longer than 6 months from diagnosis
- previous GD treatment by RAI or surgery
- SNI greater than 7.0
- urgent orbital decompression surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antithyroid DrugAlso: Thiamazol, PropylthiouracilAntithyroid drug | Drug | Thyroidectomy |
| Total thyroidectomyOperation | Procedure or surgery | Antithyroid drug |
Primary outcome
Muscle index (MI) from ultrasound measurements
Time frame: 12 months
Muscle index (MI) from ultrasound measurements
Thyroid antibodies
Time frame: 12 months
Thyroid antibodies
3 secondary outcomes
CAScore/NOSPECS score
Time frame: 12 months
Superonasal index measurements via ultrasound
Time frame: 12 months
Quality of life score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: No. No IPD sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Riss, MD principal investigator
Medical University of Vienna
Guido Dorner, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antithyroid Drug and Total thyroidectomy in people with Graves Disease and Graves Ophthalmopathy, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindsay Brammen, MD (+4314040056210, lindsay.brammen@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle index (MI) from ultrasound measurements (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.