Graves' Disease Remission Study: MycoMeth Combo (3M-RGD)

Xiamen University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Graves' Disease

Treatments: Drug: methimazole, oral, 10mg; Drug: Mycophenolate Mofetil, Oral, 250 Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06068179

XMFHIIT-2023SL059

Details and patient eligibility

About

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

Full 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.

Enrollment: 205 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 2 patient groups

intervention group

Experimental group

Description:

Mycophenolate Mofetil 0.5 twice daily for 12 months added to methimazole standard therapy.

Treatment:

Drug: methimazole, oral, 10mg

Drug: Mycophenolate Mofetil, Oral, 250 Mg

control group

Active Comparator group

Description:

Methimazole 15-30mg daily initially, then titrate to maintenance dose. Beta-blocker used when necessary.

Treatment:

Drug: methimazole, oral, 10mg