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A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Summary
Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.
Official title: Comparison of Two Intravenous Methylprednisolone Protocols in Patients With Graves Orbitopathy: a Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-07
Completion Date
2026-12
Last Updated
2024-07-19
Healthy Volunteers
No
Conditions
Interventions
methylprednisolone(daily scheme)
0.5 g methylprednisolone i.v. daily for 5 consecutive days, followed by oral prednisone for 6 months. Oral prednisone started at 40 mg/day for 4 weeks and then the dose was tapered by 5 mg/day every 2-4 weeks.
methylprednisolone(weekly scheme)
0.5 g methylprednisolone i.v. weekly for 6 weeks and then the dose was tapered by 0.25 g/week over the following 6 weeks.