Graves' Disease Remission Study: MycoMeth Combo

Phase 2

Recruiting

• Conditions: Graves' Disease
• Interventions: Drug: methimazole, oral, 10mg; Drug: Mycophenolate Mofetil, Oral, 250 Mg

• Registration Number: NCT06068179
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Study Start: 2023-10-16
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-10-08
• Study Completion: 2026-10-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• 1. aged 18 to 60 years.

2. Patients newly diagnosed with Graves' disease.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	methimazole, oral, 10mg	Methimazole 15-30mg daily initially, then titrate to maintenance dose. Beta-blocker used when necessary.
intervention group	Mycophenolate Mofetil, Oral, 250 Mg	Mycophenolate Mofetil 0.5 twice daily for 12 months added to methimazole standard therapy.
intervention group	methimazole, oral, 10mg	Mycophenolate Mofetil 0.5 twice daily for 12 months added to methimazole standard therapy.

Primary Outcome Measures

Name	Time	Method
Remission rate	12 months	Remission is defined as normal thyroid function, TRAb level at methimazole maintenance dose

Trial Locations

Locations (1)

Xiao Fangsen; 🇨🇳 Xiamen, Fujian, China