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A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy

NCT06510114 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-19

No results posted yet for this study

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.

Conditions

  • Graves Ophthalmopathy

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Shuo Lin · Third Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-06-30
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510114 on ClinicalTrials.gov