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

Primary Purpose

Graves' Disease

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Mycophenolate Mofetil, Oral, 250 Mg
methimazole, oral, 10mg
Sponsored by
The First Affiliated Hospital of Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves' Disease focused on measuring Newly Diagnosed Graves' Disease, Mycophenolate Mofetil, Methimazole, Remission

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    intervention group

    control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Remission rate
    Remission is defined as normal thyroid function, TRAb level at methimazole maintenance dose

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2023
    Last Updated
    September 28, 2023
    Sponsor
    The First Affiliated Hospital of Xiamen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06068179
    Brief Title
    Graves' Disease Remission Study: MycoMeth Combo
    Acronym
    3M-RGD
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 8, 2023 (Anticipated)
    Primary Completion Date
    October 8, 2025 (Anticipated)
    Study Completion Date
    October 8, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital of Xiamen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Graves' Disease
    Keywords
    Newly Diagnosed Graves' Disease, Mycophenolate Mofetil, Methimazole, Remission

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Outcomes Assessor
    Masking Description
    The study grouping will be blinded to outcomes assessor.
    Allocation
    Randomized
    Enrollment
    205 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    Mycophenolate Mofetil 0.5 twice daily for 12 months added to methimazole standard therapy.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Methimazole 15-30mg daily initially, then titrate to maintenance dose. Beta-blocker used when necessary.
    Intervention Type
    Drug
    Intervention Name(s)
    Mycophenolate Mofetil, Oral, 250 Mg
    Other Intervention Name(s)
    methimazole, oral, 10mg
    Intervention Description
    Mycophenolate Mofetil, Oral, 500Mg twice daily for 12 months, combined with methimazole standard therapy
    Intervention Type
    Drug
    Intervention Name(s)
    methimazole, oral, 10mg
    Intervention Description
    Methimazole 15-30mg daily initially then titrate to maintenance dose.
    Primary Outcome Measure Information:
    Title
    Remission rate
    Description
    Remission is defined as normal thyroid function, TRAb level at methimazole maintenance dose
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32616746
    Citation
    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.
    Results Reference
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    PubMed Identifier
    26670972
    Citation
    Burch HB, Cooper DS. Management of Graves Disease: A Review. JAMA. 2015 Dec 15;314(23):2544-54. doi: 10.1001/jama.2015.16535. Erratum In: JAMA. 2016 Feb 9;315(6):614.
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    PubMed Identifier
    27797318
    Citation
    Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
    Results Reference
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    PubMed Identifier
    32929476
    Citation
    Kahaly GJ. Management of Graves Thyroidal and Extrathyroidal Disease: An Update. J Clin Endocrinol Metab. 2020 Dec 1;105(12):3704-20. doi: 10.1210/clinem/dgaa646.
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    PubMed Identifier
    30912336
    Citation
    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.
    Results Reference
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    PubMed Identifier
    27521067
    Citation
    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. Erratum In: Thyroid. 2017 Nov;27(11):1462.
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    Citation
    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.
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    PubMed Identifier
    32055040
    Citation
    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.
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    Citation
    Prussick L, Plotnikova N, Gottlieb A. Mycophenolate Mofetil in Severe Atopic Dermatitis: A Review. J Drugs Dermatol. 2016 Jun 1;15(6):715-8.
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    PubMed Identifier
    36346684
    Citation
    Barbesino G, Salvi M, Freitag SK. Future Projections in Thyroid Eye Disease. J Clin Endocrinol Metab. 2022 Aug 8;107(Suppl_1):S47-S56. doi: 10.1210/clinem/dgac252.
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    PubMed Identifier
    29396246
    Citation
    Kahaly GJ, Riedl M, Konig J, Pitz S, Ponto K, Diana T, Kampmann E, Kolbe E, Eckstein A, Moeller LC, Fuhrer D, Salvi M, Curro N, Campi I, Covelli D, Leo M, Marino M, Menconi F, Marcocci C, Bartalena L, Perros P, Wiersinga WM; European Group on Graves' Orbitopathy (EUGOGO). Mycophenolate plus methylprednisolone versus methylprednisolone alone in active, moderate-to-severe Graves' orbitopathy (MINGO): a randomised, observer-masked, multicentre trial. Lancet Diabetes Endocrinol. 2018 Apr;6(4):287-298. doi: 10.1016/S2213-8587(18)30020-2. Epub 2018 Jan 31.
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    Graves' Disease Remission Study: MycoMeth Combo

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