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

Phase 4

Not yet recruiting

• Conditions: Graves Ophthalmopathy
• Interventions: Drug: methylprednisolone(daily scheme); Drug: methylprednisolone(weekly scheme)

• Registration Number: NCT06510114
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Detailed Description

The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO.

Study Timeline

• Study First Submitted: 2024-06-24
• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age 18-65 years old;
2. diagnosed as thyroid associated ophthalmopathy by using Bartley criteria，Moderate to severe (EUGOGO grade), with CAS≥3 points;
3. Thyroid function normally lasts for more than 2 months, with oral antithyroid drugs or thyroid surgery, or six months after iodine-131 treatment;
4. without receiving immunosuppressive therapy for thyroid eye disease before.

Exclusion Criteria

(1) severe cardiac, liver and renal insufficiency (2) acute or chronic viral hepatitis or tuberculosis (3) optic neuropathy (4) received immunosuppressive and glucocorticoid therapy for any reason within the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	methylprednisolone(daily scheme)	The daily scheme was as follows: 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.
Group B	methylprednisolone(weekly scheme)	The weekly protocol was as follows: 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.

Primary Outcome Measures

Name	Time	Method
the overall response rate at 24 week	24 week	"Response" was defined as an improvement in at least two of the following four criteria were present, and the contralateral eye disease did not worsen: (1) the width of the eyelid was reduced by ≥2 mm; (2) The five scores of eyelid congestion, eyelid edema, conjunctival congestion, conjunctival edema and carunculae lacrimalis swelling in CAS decreased by ≥1 point; (3) The regression of exophthalmos ≥2 mm; (4) Increased eye movement ≥8° or improved diplopia ≥ grade I (continuous to interrupted, interrupted to brief, brief to none).

Secondary Outcome Measures

Name	Time	Method
Changes of clinical activity score (CAS) from baseline to 24 week	24 week	changes of clinical activity score (CAS) from baseline to 24 week
changes of quality of life score (QoF-s) from baseline to 24 week	24 week	changes of quality of life score (QoF-s )
changes of exophthalmos from baseline to 24 week	24 week	changes of exophthalmos from baseline to 24 week
changes of width of the eyelid from baseline to 24 week	24 week	changes of width of the eyelid from baseline to 24 week
changes of diplopia grade from baseline to 24 week	24 week	changes of diplopia grade from baseline to 24 week