Comparison of the Effectiveness of Two Glucocorticoid Regimens for Treatment of Graves' Orbitopathy

Medical University of Sofia

Status: Completed

Conditions: Graves Ophthalmopathy

Treatments: Drug: Methylprednisolone

Study type: Observational

Funder types: Other

Identifiers

NCT05793359

21A /25.07.2017

Details and patient eligibility

About

The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are:

1. Are the two glucocorticoid regimens similarly effective?
2. Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. Their ocular status, therapeutic response and quality of life reassessed during the treatment, at its end, and 3 month later.

Full description

Systemic glucocorticoids are the mainstay of treatment for active moderate-to-severe Graves' orbitopathy. However, there are a number of different glucocorticoid regimens with different total dosage, schemes of administration and duration. The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are:

1. Are the two glucocorticoid regimens similarly effective?
2. Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. The first group is treated with modified monthly regimen, including 3 pulses of 3 infusions of 500 mg methylprednisolone administered in three consecutive months, with application of 125 mg methylprednisolone intramuscularly once per week between the pulses. Total cumulative dose - 5.5. g., duration - 3 months. After completion of the venous infusions, a low dose peroral glucocorticoid therapy is prescribed for the next 3 months. The second group is treated with weekly glucocorticoid regimen: 6 infusions of 500 mg methylprednisolone during the first 6 weeks followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks. Total cumulative dose - 4.5 g., duration - 3 months. Patients' ocular status and therapeutic response are assessed at 1st, 3rd and 6th months; quality of life - at 3rd and 6th month.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active moderate-to-severe Graves' orbitopathy
• Without previous treatment with glucocorticoids or orbital radiotherapy
• Euthyroid state

Exclusion criteria

• Uncontrolled hyper- or hypothyroidism
• Previously treated Graves' orbitopathy
• Mild or sight-threatening form of Graves' orbitopathy
• Inactive moderate-to-severe Graves' orbitopathy
• Contraindications for glucocorticoid treatment

Trial design

62 participants in 2 patient groups

Modified monthly regimen

Description:

Treatment with 3 pulses of 3 infusions of 500 mg methylprednisolone on 3 consecutive months with intramuscular administration of 125 mg methylprednisolone per week between the pulses. Additional low dose peroral treatment after completion of the pulses.

Treatment:

Drug: Methylprednisolone

Weekly regimen

Description:

Treatment with 6 infusions of 500 mg methylprednisolone during the first 6 weeks, followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks.

Treatment:

Drug: Methylprednisolone