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

NCT06510114 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: RG2024-016-01
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Graves Ophthalmopathy

Keywords

Hyperthyroidism; Graves Ophthalmopathy; glucocorticoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  24 week

• changes of exophthalmos from baseline to 24 week

  24 week

• changes of width of the eyelid from baseline to 24 week

  24 week

• changes of diplopia grade from baseline to 24 week

  24 week

Other Outcomes (5)

• Changes of blood pressure from baseline to 24 week

  24 week

• Changes of weight from baseline to 24 week

  24 week

• Changes of fasting blood glucose from baseline to 24 week

  24 week

Study Arms (2)

Group A

EXPERIMENTAL

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)

Group B

ACTIVE COMPARATOR

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)

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.

Also known as: prednisone

Group A

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.

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Conditions

Graves Ophthalmopathy; Hyperthyroidism

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shuo Lin

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuo Lin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants with active moderate-to-severe GO were randomized at a ratio of 1:1 to receive glucocorticoid therapy for 12 weeks on a weekly protocol or daily scheme.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 19, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share