Graves' Disease Remission Study: MycoMeth Combo
The Efficacy and Safety of Combining Mycophenolate Mofetil With Methimazole on Remission of Newly Diagnosis Graves' Disease (3M-RGD Trial): an Open-label, Randomized Trial
The First Affiliated Hospital of Xiamen University
205 participants
Oct 16, 2023
INTERVENTIONAL
Conditions
Summary
A randomized study to evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed Graves' disease.
Eligibility
Inclusion Criteria2
- \- 1. aged 18 to 60 years.
- \. Patients newly diagnosed with Graves' disease.
Exclusion Criteria11
- \. Patients with Graves' disease who have undergone treatment or experienced relapse.
- \. Hyperthyroidism due to other etiologies (toxic multinodular goiter, toxic thyroid adenoma, Hashimoto's thyroiditis, subacute thyroiditis, iodine-induced hyperthyroidism, etc.).
- \. Individuals requiring intervention for moderate to severe thyroid eye disease at the time of enrollment.
- \. Patients with hyperthyroidism requiring surgery due to concurrent thyroid cancer.
- \. Those with severe liver or kidney dysfunction (ALT or AST > 3 times the upper limit of normal reference values, blood creatinine > 135 mol/L for males, and 110 mol/L for females).
- \. Individuals with leukopenia (WBC < 3.0×109/L).
- \. Patients with severe heart failure (NYHA class III or IV).
- \. Individuals with chronic or severe infections such as pulmonary tuberculosis, hepatitis B, etc.
- \. Pregnant women, breastfeeding women, those planning pregnancy in the near future, or individuals who cannot comply with contraception during trial.
- \. Participants in or previously involved in other clinical studies.
- \. Individuals unwilling or unable to comply with follow-up or unwilling to participate.
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Interventions
Mycophenolate Mofetil, Oral, 500Mg twice daily for 12 months, combined with methimazole standard therapy
Methimazole 15-30mg daily initially then titrate to maintenance dose.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06068179