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

NCT06693856 | Enrolling By Invitation

• 1 other identifier: 2024SL126
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Graves Ophthalmopathy

Keywords

Graves ophthalmopathy, methylprednisolone, therapy regimens

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate, ORR

  The percentage of subjects with improvement in Graves' ophthalmopathy at week 24.

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (3)

• CAS and proptosis

  From enrollment to the end of treatment at 24 weeks

• Clinical Activity Score

  From enrollment to the end of treatment at 24 weeks

• proptosis

  From enrollment to the end of treatment at 24 weeks

Other Outcomes (1)

• Recurrence Rate, RR

  From enrollment to the end of treatment at 48 weeks

Study Arms (2)

a high-dose group

ACTIVE COMPARATOR

methylprednisolone 500mg, D1-3, once every 4 weeks

Drug: High-Dose Methylprednisolone

a low-dose group

EXPERIMENTAL

methylprednisolone 1mg/kg, D1-3, once every 4 weeks

Drug: Low-Dose Methylprednisolone

Interventions

High-Dose Methylprednisolone DRUG

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.

a high-dose group

Low-Dose Methylprednisolone DRUG

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.

a low-dose group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily accept the study and sign the informed consent form.
• Age between 25 and 70 years old at the time of enrollment, both males and females are eligible.
• Newly diagnosed Graves' ophthalmopathy, moderate to severe active patients. The criteria for moderate to severe GO are: ① eyelid retraction ≥2mm; ② moderate to severe involvement of orbital soft tissues; ③ proptosis ≥20mm; ④ periodic or persistent diplopia. Meeting one of the above four criteria is sufficient.
• The criteria for active GO are: CAS score ≥4 points. Scoring criteria: ① spontaneous retro-ocular pain; ② pain on eye movement; ③ conjunctival congestion; ④ eyelid congestion; ⑤ chemosis of the conjunctiva; ⑥ swelling of the caruncle; ⑦ eyelid edema. One point is recorded for each of the above seven symptoms if present, and zero if absent.
• The onset of Graves' ophthalmopathy does not exceed 12 months, and those who have not been treated with glucocorticoids or other immunosuppressive agents.
• Women of childbearing age must use effective contraceptive measures.
• At the time of screening, hyperthyroidism in the study subjects should be basically controlled. Thyroid function should be normal or only mildly abnormal, defined as FT4 and FT3 levels within 50% of the upper and lower limits of the normal range. Mild thyroid dysfunction should be corrected as much as possible, and a normal thyroid function state should be maintained throughout the clinical trial period.

You may not qualify if:

• Pregnant women, women who are breastfeeding, or women planning to become pregnant during the trial period.
• Severe cardiac diseases such as myocardial infarction, unstable angina, and chronic heart failure.
• Known liver diseases, or alanine transaminase (ALT) levels more than 1.5 times the upper limit of normal.
• Chronic kidney disease, or serum creatinine \>135 umol/L (\>1.5 mg/dL).
• Individuals with diabetes, and HbA1c \>9.0%.
• Individuals with a history of alcohol abuse or drug use.
• Subjects with a white blood cell count \<4.0×10\^9/L, or a platelet count \<80×10\^9/L.
• Significant anemia (hemoglobin levels \<110 g/L in males, \<100 g/L in females).
• Patients with psychiatric disorders, or those who are non-cooperative.
• Individuals with optic nerve involvement requiring orbital decompression surgery. Defined as a decrease in vision by more than two lines in the past six months, or new visual field defects, or color vision deficiencies.
• Corneal ulcers, contraindications for glucocorticoid treatment.

Sponsors & Collaborators

• Zou Junjie: lead

Study Sites (3)

Shanghai Changzhen Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

Shanghai Longhua Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Methylprednisolone

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; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zou JJ Professor

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The IPD and supporting information will be available starting from July 1, 2027 for 6 months.
• Access Criteria: Data will only be provided after application and approval. Applicants must provide a reasonable data usage plan and commit to protecting participant privacy. Data usage must comply with relevant ethical and legal requirements. Interested researchers need to submit data sharing requests through the designated Clinical Trial Management Public Platform. Requests will be reviewed by the platform's management committee. Once approved, researchers will be granted access to de-identified IPD. The data will be stored on the servers of the Clinical Trial Management Public Platform, and the access address is: http://www.medresman.org.cn/login.aspx.

Locations

CN (3)