Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
205 participants
INTERVENTIONAL
2023-10-16
2026-10-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Follow-up Study on Drug Therapy for Graves' Disease Patients in China
NCT07040306
Rapamycin Plus Methylprednisolone Versus Methylprednisolone Alone in Active, Moderate-to-severe Graves' Orbitopathy.
NCT05532072
Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease
NCT05461820
Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone
NCT00917241
Efficacy of Methimazole Dosing Algorithm
NCT05964452
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
intervention group
Mycophenolate Mofetil 0.5 twice daily for 12 months added to methimazole standard therapy.
Mycophenolate Mofetil, Oral, 250 Mg
Mycophenolate Mofetil, Oral, 500Mg twice daily for 12 months, combined with methimazole standard therapy
methimazole, oral, 10mg
Methimazole 15-30mg daily initially then titrate to maintenance dose.
control group
Methimazole 15-30mg daily initially, then titrate to maintenance dose. Beta-blocker used when necessary.
methimazole, oral, 10mg
Methimazole 15-30mg daily initially then titrate to maintenance dose.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mycophenolate Mofetil, Oral, 250 Mg
Mycophenolate Mofetil, Oral, 500Mg twice daily for 12 months, combined with methimazole standard therapy
methimazole, oral, 10mg
Methimazole 15-30mg daily initially then titrate to maintenance dose.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2\. Patients newly diagnosed with Graves' disease.
Exclusion Criteria
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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The First Affiliated Hospital of Xiamen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fangsen Xiao, MD
Role: PRINCIPAL_INVESTIGATOR
The first affiliated hospital of Xiamen University Medical College
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xiao Fangsen
Xiamen, Fujian, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Burch HB, Cooper DS. Management of Graves Disease: A Review. JAMA. 2015 Dec 15;314(23):2544-54. doi: 10.1001/jama.2015.16535.
Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
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.
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.
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.
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.
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.
Prussick L, Plotnikova N, Gottlieb A. Mycophenolate Mofetil in Severe Atopic Dermatitis: A Review. J Drugs Dermatol. 2016 Jun 1;15(6):715-8.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
XMFHIIT-2023SL059
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.