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

Phase 4Not Yet RecruitingNCT06510114

Third Affiliated Hospital, Sun Yat-Sen University150 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Graves Ophthalmopathy

Interventions

methylprednisolone(daily scheme)DRUG

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)DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

the overall response rate at 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).

Time frame: 24 week

Secondary Outcomes

Changes of clinical activity score (CAS) from baseline to 24 week

changes of clinical activity score (CAS) from baseline to 24 week

Time frame: 24 week

changes of quality of life score (QoF-s) from baseline to 24 week

changes of quality of life score (QoF-s )

Time frame: 24 week

changes of exophthalmos from baseline to 24 week

Time frame: 24 week

changes of width of the eyelid from baseline to 24 week

Time frame: 24 week

changes of diplopia grade from baseline to 24 week

Time frame: 24 week

Central Contacts

Shuo Lin

CONTACT

020-85253408 linshuo3@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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