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

February 27, 2024 updated by: The First Affiliated Hospital of Xiamen University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

205

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fangsen Xiao, MD
  • Phone Number: +8613859955389
  • Email: xfs888@163.com

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • Xiao Fangsen
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission rate
Time Frame: 12 months
Remission is defined as normal thyroid function, TRAb level at methimazole maintenance dose
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: Fangsen Xiao, MD, The first affiliated hospital of Xiamen University Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Estimated)

October 8, 2025

Study Completion (Estimated)

October 8, 2026

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMFHIIT-2023SL059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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