Methimazole in Graves' Disease - Comparing the Computer-aided Treatment DigiThy Versus Usual Care

Launched by MEDICAL UNIVERSITY OF GRAZ · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different ways of adjusting the dosage of a medication called methimazole for patients with Graves' disease, a condition that causes an overactive thyroid. One method uses a new computer-guided treatment system that helps determine the best dose based on advanced calculations, while the other method relies on the judgment of the doctor (known as usual care). The main goal is to find out if the computer-guided approach is just as safe and effective as the traditional method.

To participate in this trial, individuals must be 18 years or older and have active Graves' disease, which means their thyroid hormone levels are higher than normal. They should not have started any antithyroid treatment yet or have been on it for less than four weeks. Participants will be closely monitored during the study to see how well the two methods work in managing their condition. It's important to note that people who are pregnant, have been treated with radioactive iodine, or have received certain other treatments for more than a month won't be eligible to join this trial.

Gender

ALL

Eligibility criteria

• 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