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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Remission rate
研究概览
简要总结
A randomized study to evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed Graves' disease.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study grouping will be blinded to outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 to 60 years.
- •Patients newly diagnosed with Graves' disease.
排除标准
- •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.
研究组 & 干预措施
intervention group
Mycophenolate Mofetil 0.5 twice daily for 12 months added to methimazole standard therapy.
干预措施: Mycophenolate Mofetil, Oral, 250 Mg (Drug)
intervention group
Mycophenolate Mofetil 0.5 twice daily for 12 months added to methimazole standard therapy.
干预措施: methimazole, oral, 10mg (Drug)
control group
Methimazole 15-30mg daily initially, then titrate to maintenance dose. Beta-blocker used when necessary.
干预措施: methimazole, oral, 10mg (Drug)
结局指标
主要结局
Remission rate
时间窗: 12 months
Remission is defined as normal thyroid function, TRAb level at methimazole maintenance dose
次要结局
未报告次要终点