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Multi-center Prospective Clinical Study on Glucocorticoid Pulse Therapy for Graves' Ophthalmopathy (GO)
Sponsor: Zou Junjie
Summary
This study plans to include newly diagnosed, active, moderate to severe Graves' ophthalmopathy patients, divided into a high-dose group (methylprednisolone 500mg, D1-3, once every 4 weeks) and a low-dose group (methylprednisolone 1mg/kg, D1-3, once every 4 weeks), with a treatment duration of 24 weeks to compare the efficacy and safety of the two groups. Additionally, this study will extend the follow-up to 48 weeks to observe the recurrence rate after treatment in both groups, exploring the heterogeneity of the active course of Graves' ophthalmopathy.
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Different Methylprednisolone Pulse Therapy Regimens for the Treatment of Graves' Ophthalmopathy
Key Details
Gender
All
Age Range
25 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-01-01
Completion Date
2026-12-31
Last Updated
2025-05-22
Healthy Volunteers
No
Conditions
Interventions
High-Dose Methylprednisolone
Methylprednisolone 500mg, administered intravenously once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks, followed by a follow-up period.
Low-Dose Methylprednisolone
Methylprednisolone is administered at a dose of 1mg/kg, given as an intravenous injection once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks, followed by a follow-up period.
Locations (3)
Shanghai Changzhen Hospital
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Shanghai Longhua Hospital
Shanghai, Shanghai Municipality, China