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Phase 2
Phase 3
Age: 18Years - 60Years
All Genders
ID06068179

Evaluating Mycophenolate Mofetil Combined with Methimazole for Treating Newly Diagnosed Graves Disease A Randomized Trial on Treatment Effectiveness and Safety

Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-02-28

205

Participants Needed

1

Research Sites

52 weeks

Total Duration

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

Research Team

F

Fangsen Xiao, MD

L

Liyin Wang, MM

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