Graves' Disease Remission Study: MycoMeth Combo

NCT06068179 | Recruiting Phase 2

• 1 other identifier: XMFHIIT-2023SL059
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Graves' Disease

Keywords

Newly Diagnosed Graves' Disease; Mycophenolate Mofetil; Methimazole; Remission

Outcome Measures

Primary Outcomes (1)

• Remission rate

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

  12 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

Drug: Mycophenolate Mofetil, Oral, 250 Mg; Drug: methimazole, oral, 10mg

control group

ACTIVE COMPARATOR

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

Drug: methimazole, oral, 10mg

Interventions

Mycophenolate Mofetil, Oral, 250 Mg DRUG

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

intervention group

methimazole, oral, 10mg DRUG

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

control group; intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 1. aged 18 to 60 years.
• \. Patients newly diagnosed with Graves' disease.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

Xiao Fangsen

Xiamen, Fujian, 361003, China

RECRUITING

Related Publications (13)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 32929476 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Prussick L, Plotnikova N, Gottlieb A. Mycophenolate Mofetil in Severe Atopic Dermatitis: A Review. J Drugs Dermatol. 2016 Jun 1;15(6):715-8.

  PMID: 27272078 RESULT

• 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.

  PMID: 36346684 RESULT

• 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.

  PMID: 29396246 RESULT

• Rajabi MT, Rafizadeh SM, Mohammadi A, Eshraghi B, Mohammadi N, Hosseini SS, Rajabi MB, Keshmirshekan MM, Shahriari M, Poursayed Lazarjani SZ, Parandin MM. Mycophenolate Mofetil (CellCept(R)) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy. Front Med (Lausanne). 2022 Feb 11;9:788228. doi: 10.3389/fmed.2022.788228. eCollection 2022.

  PMID: 35223896 RESULT

• Feng W, Hu Y, Zhang C, Shi H, Zhang P, Yang Y, Chen S, Cui W, Cui D. Efficacy and safety of mycophenolate mofetil in the treatment of moderate to severe Graves' orbitopathy: a meta-analysis. Bioengineered. 2022 Jun;13(6):14719-14729. doi: 10.1080/21655979.2022.2101191.

  PMID: 35959915 RESULT

MeSH Terms

Conditions

Graves Disease

Interventions

Mycophenolic Acid; Methimazole

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Sulfhydryl Compounds; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fangsen Xiao, MD

  The first affiliated hospital of Xiamen University Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangsen Xiao, MD

CONTACT

+8613859955389; xfs888@163.com

Liyin Wang, MM

CONTACT

+8613950139047; wlywly1979@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study grouping will be blinded to outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: October 16, 2023
• Primary Completion: October 8, 2025
• Study Completion (Estimated): October 8, 2026
• Last Updated: February 28, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)