Combining mycophenolate mofetil with methimazole for newly diagnosed Graves' disease
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
This study is testing if adding mycophenolate mofetil to methimazole can help people newly diagnosed with Graves' disease achieve better remission rates.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 205 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT06068179 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a combination therapy using mycophenolate mofetil and methimazole in patients who have recently been diagnosed with Graves' disease. The current standard treatment with methimazole has a remission rate of only about 50%, prompting researchers to explore whether adding an immunosuppressor like mycophenolate mofetil can enhance this outcome. A total of 205 eligible participants will be randomly assigned to receive either the combination therapy or standard methimazole treatment, with the primary goal of assessing remission rates after 12 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 who have been newly diagnosed with Graves' disease.
Not a fit: Patients with Graves' disease who have previously undergone treatment or have other forms of hyperthyroidism will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve remission rates for patients with newly diagnosed Graves' disease.
How similar studies have performed: While the combination of these specific treatments is novel, similar approaches in enhancing remission rates for autoimmune conditions have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xiamen, Fujian
- Xiao Fangsen — Xiamen, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Fangsen Xiao, MD — The first affiliated hospital of Xiamen University Medical College
- Study coordinator: Fangsen Xiao, MD
- Email: xfs888@163.com
- Phone: +8613859955389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.