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Recruiting NCT06068179

Graves' Disease Remission Study: MycoMeth Combo

Phase II / Phase III Interventional Graves' Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mycophenolate Mofetil, Oral, 250 Mg, methimazole, oral, 10mg.
Who it may be relevant to
Registry conditions: Graves' Disease. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Mycophenolate Mofetil, Oral, 250 Mg
    Mycophenolate Mofetil, Oral, 500Mg twice daily for 12 months, combined with methimazole standard therapy
  • Drug methimazole, oral, 10mg
    Methimazole 15-30mg daily initially then titrate to maintenance dose.

Primary outcome measures

  • Remission rate [Time frame: 12 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xiao Fangsen — Xiamen

Publications

  • Davies TF, Andersen S, Latif R, Nagayama Y, Barbesino G, Brito M, Eckstein AK, Stagnaro-Green A, Kahaly GJ. Graves' disease. Nat Rev Dis Primers. 2020 Jul 2;6(1):52. doi: 10.1038/s41572-020-0184-y. PMID 32616746
  • Burch HB, Cooper DS. Management of Graves Disease: A Review. JAMA. 2015 Dec 15;314(23):2544-54. doi: 10.1001/jama.2015.16535. PMID 26670972
  • Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available. PMID 27797318
  • Kahaly GJ. Management of Graves Thyroidal and Extrathyroidal Disease: An Update. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa646. doi: 10.1210/clinem/dgaa646. PMID 32929476
  • Wiersinga WM. Graves' Disease: Can It Be Cured? Endocrinol Metab (Seoul). 2019 Mar;34(1):29-38. doi: 10.3803/EnM.2019.34.1.29. PMID 30912336
  • Ross DS, Burch HB, Cooper DS, Greenlee MC, Laurberg P, Maia AL, Rivkees SA, Samuels M, Sosa JA, Stan MN, Walter MA. 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis. Thyroid. 2016 Oct;26(10):1343-1421. doi: 10.1089/thy.2016.0229. PMID 27521067
  • Torlinska B, Hazlehurst JM, Nirantharakumar K, Thomas GN, Priestley JR, Finnikin SJ, Saunders P, Abrams KR, Boelaert K. wEight chanGes, caRdio-mEtabolic risks and morTality in patients with hyperthyroidism (EGRET): a protocol for a CPRD-HES linked cohort study. BMJ Open. 2021 Oct 1;11(10):e055219. doi: 10.1136/bmjopen-2021-055219. PMID 34598995
  • Broen JCA, van Laar JM. Mycophenolate mofetil, azathioprine and tacrolimus: mechanisms in rheumatology. Nat Rev Rheumatol. 2020 Mar;16(3):167-178. doi: 10.1038/s41584-020-0374-8. Epub 2020 Feb 13. PMID 32055040

Identifiers

NCT: NCT06068179 · XMFHIIT-2023SL059

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗