Clinical trial NCT06068179: Graves' Disease Remission Study: MycoMeth Combo
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Graves' Disease
Keywords: Newly Diagnosed Graves' Disease
Mycophenolate Mofetil
Methimazole
Remission
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Remission rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiao Fangsen
state: Fujian
Study officials:
affiliation: The first affiliated hospital of Xiamen University Medical College
name: Fangsen Xiao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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