drugset / Trial / NCT06693856

Multi-center Prospective Clinical Study on Glucocorticoid Pulse Therapy for Graves' Ophthalmopathy (GO)

NCT06693856

Enrolling by invitation 120 enrolled Zou Junjie
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-01
Primary completion
2026-06-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 1 mg/kg Intravenous
Subject Methylprednisolone Other / unclassified 500 mg Intravenous