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

Sponsor

The First Affiliated Hospital of Xiamen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06068179

Collaborator

(none)

205

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Graves' Disease	Drug: Mycophenolate Mofetil, Oral, 250 Mg Drug: methimazole, oral, 10mg	Phase 2/Phase 3

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. We 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 Design

Study Type:

Interventional

Anticipated Enrollment :

205 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.Eligible patients will be randomly assigned to intervention group (Mycophenolate Mofetil combine with methimazole) or control group (methimazole standard therapy) for 12 months.

Masking:

Single (Outcomes Assessor)

Masking Description:

The study grouping will be blinded to outcomes assessor.

Primary Purpose:

Treatment

Official Title:

he Efficacy and Safety of Combining Mycophenolate Mofetil With Methimazole on Remission of Newly Diagnosis Graves' Disease (3M-RGD Trial): an Open-label, Randomized Trial

Anticipated Study Start Date :

Oct 8, 2023

Anticipated Primary Completion Date :

Oct 8, 2025

Anticipated Study Completion Date :

Oct 8, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group Mycophenolate Mofetil 0.5 twice daily for 12 months added to methimazole standard therapy.	Drug: Mycophenolate Mofetil, Oral, 250 Mg Mycophenolate Mofetil, Oral, 500Mg twice daily for 12 months, combined with methimazole standard therapy Other Names: methimazole, oral, 10mg Drug: methimazole, oral, 10mg Methimazole 15-30mg daily initially then titrate to maintenance dose.
Active Comparator: control group Methimazole 15-30mg daily initially, then titrate to maintenance dose. Beta-blocker used when necessary.	Drug: methimazole, oral, 10mg Methimazole 15-30mg daily initially then titrate to maintenance dose.

Arm

Intervention/Treatment

Experimental: intervention group

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

Drug: Mycophenolate Mofetil, Oral, 250 Mg

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

Other Names:

methimazole, oral, 10mg

Drug: methimazole, oral, 10mg

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

Active Comparator: control group

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

Drug: methimazole, oral, 10mg

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

Outcome Measures

Primary Outcome Measures

Remission rate [12 months]
Remission is defined as normal thyroid function, TRAb level at methimazole maintenance dose

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. aged 18 to 60 years.

Patients newly diagnosed with Graves' disease.

Exclusion Criteria:

1. 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.