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

Comparison of Two Intravenous Methylprednisolone Protocols in Patients With Graves Orbitopathy: a Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Graves Ophthalmopathy
• Intervention / Treatment: Drug: methylprednisolone(daily scheme); Drug: methylprednisolone(weekly scheme)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shuo Lin; Phone Number: 020-85253408; Email: linshuo3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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.	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.; Other Names: prednisone
Active Comparator: Group B; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 week

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of blood pressure from baseline to 24 week	Changes of blood pressure from baseline to 24 week	24 week
Changes of weight from baseline to 24 week	Changes of weight from baseline to 24 week	24 week
Changes of fasting blood glucose from baseline to 24 week	Changes of fasting blood glucose from baseline to 24 week	24 week
Changes of serum low density lipoprotein cholesterol	Changes of low density lipoprotein cholesterol from baseline to 24 week	24 week
Changes of serum triglyceride	Changes of serum triglyceride from baseline to 24 week	24 week

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Shuo Lin, Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Graves Ophthalmopathy; glucocorticoid; Hyperthyroidism
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Thyroid Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Eye Diseases; Graves Ophthalmopathy; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone
• Other Study ID Numbers: RG2024-016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No