NCT06693856

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

A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Different Methylprednisolone Pulse Therapy Regimens for the Treatment of Graves' Ophthalmopathy

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zou Junjie · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Graves' ophthalmopathy (GO) is an organ-specific autoimmune disease closely related to the thyroid gland, typically manifested by proptosis, eyelid swelling, eye pain, and double vision. Mild GO may resolve with the control of hyperthyroidism, while moderate to severe GO can severely damage vision and require more aggressive treatment. Glucocorticoids are the first-line treatment for moderate to severe, active GO, and intravenous methylprednisolone is more effective than oral glucocorticoids. The 2021 clinical practice guidelines of the European Group on Graves' Orbitopathy (EUGOGO) recommend that the optimal dosage regimen for methylprednisolone is once a week for 12 weeks, with a cumulative dose of 4.5 grams. For the most severe cases, a higher cumulative dose of up to 8 grams can also be used as monotherapy. Starting from the 1990s, the Endocrinology Department of Shanghai Changzheng Hospital began to admit patients with Graves' ophthalmopathy and initiated immunosuppressive pulse therapy, accumulating nearly 1000 cases of GO, making it the hospital with the most patients with Graves' ophthalmopathy in Shanghai and even nationwide. The monthly pulse therapy regimen has a high treatment response rate, a low relapse rate, and good safety. However, there are still a series of unresolved issues with glucocorticoid pulse therapy for Graves' ophthalmopathy. Firstly, the optimal cumulative dose of methylprednisolone has not been established. Secondly, the active course of Graves' ophthalmopathy varies greatly among individuals, with reports ranging from a few months to several years, and the pulse therapy has not yet been individualized. Thirdly, there is a significant difference in individual sensitivity to glucocorticoids; the fixed high-dose administration of methylprednisolone at 500mg per session lacks sufficient evidence. Calculating the single-dose administration based on body weight or surface area may be more reasonable. The efficacy and safety of different dosage regimens of methylprednisolone pulse therapy for Graves' ophthalmopathy will be further explored. 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.

Conditions

• Graves Ophthalmopathy

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-11-18
• Last updated: 2025-05-22

Locations

3 sites across 1 country: China