Follow-up of drug treatment for people with Graves' disease in China
A Prospective Clinical Follow-up Study of Drug Treatment in Patients With Graves' Disease
This follow-up will test how well methimazole works and who is likely to relapse among adults with new or returning Graves' disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Hospital of China Medical University Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT07040306 on ClinicalTrials.gov |
What this trial studies
This is a prospective follow-up of adults with newly diagnosed or relapsed Graves' disease treated with antithyroid drugs at a tertiary hospital in China. The study records remission and relapse rates, compares outcomes and adverse reactions between high- and low-dose methimazole, and seeks risk factors for relapse. It will also analyze TRAb test sensitivity and specificity for diagnosis and its role in predicting recurrence, and monitor liver enzymes and blood counts during treatment. The investigators plan to use the collected data to develop relapse-risk prediction software.
Who should consider this trial
Good fit: Adults (≥18 years) with newly diagnosed or relapsed Graves' disease who do not have active infiltrative exophthalmos, other autoimmune thyroid-affecting diseases, malignancy, or other serious illnesses.
Not a fit: Patients with active infiltrative exophthalmos, other autoimmune disorders affecting thyroid function, combined malignancies, or other serious illnesses were excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could help personalize methimazole dosing, reduce adverse reactions, and predict who is most likely to relapse.
How similar studies have performed: Similar observational studies and trials have previously shown that methimazole dose and TRAb levels relate to remission and relapse, though findings and optimal dosing vary across populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years old. 2. Newly diagnosed GD and GD relapses. Exclusion Criteria: 1. Patients with active infiltrative exophthalmos in GD were excluded. 2. Patients with other autoimmune diseases affecting thyroid function were excluded. 3. Excluding patients with combined malignancies and other serious diseases.
Where this trial is running
Shenyang, Liaoning
- The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Xiaochun Teng, Medical Doctor (MD)
- Email: tengxiaochun@126.com
- Phone: +8613704049020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.