Graves' Disease
Conditions
Keywords
Newly Diagnosed Graves' Disease, Mycophenolate Mofetil, Methimazole, Remission
Brief summary
A randomized study to evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed Graves' disease.
Detailed description
The remission rate of methimazole standard therapy in patients with newly diagnosed Graves' disease is only around 50%. Main reason for the low remission rate is methimazole therapy is not a drug targeting etiology of Graves' disease. The investigators hypothesize that adding mycophenolate mofetil, an immunosuppressor, to methimazole standard therapy will improve remission rate. The study will evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed Graves' disease. 205 eligible patients will be randomized to mycophenolate mofetil combined with methimazole therapy or methimazole standard therapy. The primary outcome is the remission rate at 12 months.
Interventions
DRUGMycophenolate Mofetil, Oral, 250 Mg
Mycophenolate Mofetil, Oral, 500Mg twice daily for 12 months, combined with methimazole standard therapy
DRUGmethimazole, oral, 10mg
Methimazole 15-30mg daily initially then titrate to maintenance dose.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study grouping will be blinded to outcomes assessor.
Intervention model description
Eligible patients will be randomly assigned to intervention group (Mycophenolate Mofetil combine with methimazole) or control group (methimazole standard therapy) for 12 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
\- 1. aged 18 to 60 years. 2\. Patients newly diagnosed with Graves' disease.
Exclusion criteria
* 1\. Patients with Graves' disease who have undergone treatment or experienced relapse. 2\. Hyperthyroidism due to other etiologies (toxic multinodular goiter, toxic thyroid adenoma, Hashimoto's thyroiditis, subacute thyroiditis, iodine-induced hyperthyroidism, etc.). 3\. Individuals requiring intervention for moderate to severe thyroid eye disease at the time of enrollment. 4\. Patients with hyperthyroidism requiring surgery due to concurrent thyroid cancer. 5\. 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). 6\. Individuals with leukopenia (WBC \< 3.0×109/L). 7\. Patients with severe heart failure (NYHA class III or IV). 8\. Individuals with chronic or severe infections such as pulmonary tuberculosis, hepatitis B, etc. 9\. Pregnant women, breastfeeding women, those planning pregnancy in the near future, or individuals who cannot comply with contraception during trial. 10\. Participants in or previously involved in other clinical studies. 11\. Individuals unwilling or unable to comply with follow-up or unwilling to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission rate | 12 months | Remission is defined as normal thyroid function, TRAb level at methimazole maintenance dose |
Countries
China
Contacts
Primary ContactFangsen Xiao, MD
Backup ContactLiyin Wang, MM
Outcome results
None listed