Graves' Disease Remission Study: MycoMeth Combo

Study Overview
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Brief Summary
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A randomized study to evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed Graves' disease.

Detailed Description
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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. We 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.

Official Title
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he Efficacy and Safety of Combining Mycophenolate Mofetil With Methimazole on Remission of Newly Diagnosis Graves' Disease (3M-RGD Trial): an Open-label, Randomized Trial

Conditions
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Graves' Disease

Intervention / Treatment
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* Drug: Mycophenolate Mofetil, Oral, 250 Mg
* Drug: methimazole, oral, 10mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Mycophenolate Mofetil 0.5 twice daily for 12 months added to methimazole standard therapy. | Drug: Mycophenolate Mofetil, Oral, 250 Mg<br>* Mycophenolate Mofetil, Oral, 500Mg twice daily for 12 months, combined with methimazole standard therapy<br>* Other names: methimazole, oral, 10mg;Drug: methimazole, oral, 10mg<br>* Methimazole 15-30mg daily initially then titrate to maintenance dose.<br>|
| Active Comparator: control group<br>Methimazole 15-30mg daily initially, then titrate to maintenance dose. Beta-blocker used when necessary. | Drug: methimazole, oral, 10mg<br>* Methimazole 15-30mg daily initially then titrate to maintenance dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate | Remission is defined as normal thyroid function, TRAb level at methimazole maintenance dose | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newly Diagnosed Graves' Disease, Mycophenolate Mofetil, Methimazole, Remission