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

NCT ID: NCT06510114

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-12-31

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.

Conditions

Graves Ophthalmopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

methylprednisolone(daily scheme)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

methylprednisolone(weekly scheme)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

prednisone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Shuo Lin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuo Lin

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Central Contacts

Shuo Lin

Role: CONTACT

linshuo3@mail.sysu.edu.cn

020-85253408

Other Identifiers

RG2024-016-01

Identifier Type: -

Identifier Source: org_study_id