Graves Disease
Conditions
Brief summary
The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required.
Interventions
DEVICESemi-automated computer-aided treatment (Digital Thyroid, DigiThy)
Semi-automated computer-aided treatment based on a mathematical model
PROCEDUREUsual care
Guiding methimazole therapy based on the treating physician's decision
Sponsors
Graz University of Technology
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active Graves' hyperthyroidism \[Thyroid-stimulating hormone \<0.1 mU/L, elevated free thyroxine levels (fT4) above the upper limit of normal and positive Thyrotropin receptor antibody (TRAb) according to local laboratory results\], measured within the last month prior to the inclusion date * Patients not yet receiving antithyroid treatment, or having received antithyroid treatment continuously for less than 4 weeks, or relapse or recurrence of Graves' hyperthyroidism defined as patients previously having received and discontinued treatment with antithyroid drugs for at least 4 weeks) * Age 18 years or older * Provision of written informed consent
Exclusion criteria
* Previous treatment with radioactive iodine * Ongoing antithyroid treatment for more than one month * Pregnancy * Treatment with propylthiouracil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices | 18 months | The performance index is the deviation from the desired free thyroxine (fT4) value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison in terms of cumulative methimazole dosing | 18 months | Comparison in terms of cumulative methimazole dosing |
| Comparison based on free thyroxine (fT4) target range | 18 months | Comparison based on free thyroxine (fT4) target range |
Countries
Austria
Contacts
Primary ContactVerena Theiler-Schwetz, MD, PhD
Backup ContactStefan Pilz, MD, PhD
Outcome results
None listed