RecruitingPhase 2Phase 3NCT06068179

Graves' Disease Remission Study: MycoMeth Combo

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


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

205 participants

Start Date

Oct 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

  • \- 1. aged 18 to 60 years.
  • \. Patients newly diagnosed with Graves' disease.

Exclusion Criteria11

  • \. 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMycophenolate Mofetil, Oral, 250 Mg

Mycophenolate Mofetil, Oral, 500Mg twice daily for 12 months, combined with methimazole standard therapy

DRUGmethimazole, oral, 10mg

Methimazole 15-30mg daily initially then titrate to maintenance dose.


Locations(1)

Xiao Fangsen

Xiamen, Fujian, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06068179


Related Trials