Graves' disease.
Terry F Davies, Stig Andersen, Rauf Latif...
https://pubmed.ncbi.nlm.nih.gov/32616746Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 60Years
All Genders
ID06068179
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
Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-02-28
205
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of adding mycophenolate mofetil to methimazole therapy in adults newly diagnosed with Graves' disease. Since standard methimazole treatment alone leads to only about a 50% remission rate, this study aims to see if combining these medications can improve outcomes. The trial is an open-label, randomized study involving 205 patients aged 18 to 60 years. Participants will be randomly assigned to one of two groups: one receiving mycophenolate mofetil 500 mg orally twice daily for 12 months alongside standard methimazole therapy, and the other receiving methimazole alone starting at 15 to 30 mg daily with dose adjustments as needed. Beta-blockers may be used when necessary. The main treatment period lasts 12 months. During the study, participants will be monitored regularly to assess remission status at 12 months, which is the primary outcome. Safety and efficacy will be evaluated throughout the treatment period. Participants will undergo follow-up visits and assessments to track their health and response to therapy. The total participation time aligns with the one-year treatment duration.
CONDITIONS
Brief Title
Graves' Disease Remission Study: MycoMeth Combo
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 to 60 years
- Newly diagnosed with Graves' disease
You will not qualify if you...
- Previous treatment for Graves' disease or disease relapse
- Hyperthyroidism caused by other diseases such as toxic multinodular goiter, toxic thyroid adenoma, Hashimoto's thyroiditis, subacute thyroiditis, or iodine-induced hyperthyroidism
- Need for intervention due to moderate to severe thyroid eye disease at enrollment
- Hyperthyroidism requiring surgery because of concurrent thyroid cancer
- Severe liver or kidney dysfunction (ALT or AST over 3 times the normal limit, creatinine above 135 mol/L for males or 110 mol/L for females)
- Leukopenia (white blood cell count below 3.0×10^9/L)
- Severe heart failure (NYHA class III or IV)
- Chronic or severe infections such as pulmonary tuberculosis or hepatitis B
- Pregnant, breastfeeding, planning pregnancy soon, or unable to use contraception during the trial
- Participation in other clinical studies currently or previously
- Unwilling or unable to comply with follow-up or unwilling to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive either mycophenolate mofetil combined with methimazole or methimazole standard therapy to treat Graves' disease.
Regular visits according to treatment schedule
Trial Site Locations
Total: 1 location
1
Xiao Fangsen
Xiamen, Fujian, China, 361003
Actively Recruiting
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Research Team
F
Fangsen Xiao, MD
L
Liyin Wang, MM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Management of Graves Disease: A Review.
Henry B Burch, David S Cooper
https://pubmed.ncbi.nlm.nih.gov/26670972Graves' Disease.
Terry J Smith, Laszlo Hegedüs
https://pubmed.ncbi.nlm.nih.gov/27797318Management of Graves Thyroidal and Extrathyroidal Disease: An Update.
George J Kahaly
https://pubmed.ncbi.nlm.nih.gov/32929476Graves' Disease: Can It Be Cured?
Wilmar M Wiersinga
https://pubmed.ncbi.nlm.nih.gov/309123362016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis.
Douglas S Ross, Henry B Burch, David S Cooper...
https://pubmed.ncbi.nlm.nih.gov/27521067wEight chanGes, caRdio-mEtabolic risks and morTality in patients with hyperthyroidism (EGRET): a protocol for a CPRD-HES linked cohort study.
Barbara Torlinska, Jonathan M Hazlehurst, Krishnarajah Nirantharakumar...
https://pubmed.ncbi.nlm.nih.gov/34598995Mycophenolate mofetil, azathioprine and tacrolimus: mechanisms in rheumatology.
Jasper C A Broen, Jacob M van Laar
https://pubmed.ncbi.nlm.nih.gov/32055040Mycophenolate Mofetil in Severe Atopic Dermatitis: A Review.
Lisa Prussick, Natalia Plotnikova, Alice Gottlieb
https://pubmed.ncbi.nlm.nih.gov/27272078Future Projections in Thyroid Eye Disease.
Giuseppe Barbesino, Mario Salvi, Suzanne K Freitag
https://pubmed.ncbi.nlm.nih.gov/36346684