Clinical trial NCT05793359: Comparison of the Effectiveness of Two Glucocorticoid Regimens for Treatment of Graves' Orbitopathy
Official title: Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves' Orbitopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves Ophthalmopathy
Lead sponsor: Medical University of Sofia
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sixty-two patients with untreated active moderate-to-severe Graves' orbitopathy in euthyroid state under treatment.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the changes in the overall therapeutic response assessed using Bartalena's criteria during the treatment with the two glucocorticoid regimens
timeFrame: 6 months
measure: Comparison of the changes in clinical activity score, assessed using a 7- or 10-point scale and expressed in points during the treatment with the two glucocorticoid regimens
timeFrame: 6 months
measure: Comparison of the changes in lid aperture expressed in mm during the treatment with the two glucocorticoid regimens
timeFrame: 6 months
measure: Comparison of the changes in proptosis expressed in mm during the treatment with the two glucocorticoid regimens
timeFrame: 6 months
measure: Comparison of the changes in visual acuity expressed in decimals during the treatment with the two glucocorticoid regimens
timeFrame: 6 months
measure: Comparison of the changes in diplopia assessed using Gorman's classification system during the treatment with the two glucocorticoid regimens
timeFrame: 6 months
measure: Comparison of the changes in soft tissue involvement evaluated using the colour atlas proposed by European Group on Graves' orbitopathy during the treatment with the two glucocorticoid regimens
timeFrame: 6 months
measure: Comparison of the changes in subjective symptoms whose severity was reported by patients themselves using subjective scale during the treatment with the two glucocorticoid regimens
timeFrame: 6 months
measure: Comparison of the changes in quality of life assessed by disease-specific questionnaire recommended by European Group on Graves' orbitopathy (GO-QoL) аnd expressed as percentages during the treatment with the two glucocorticoid regimens
timeFrame: 6 months
measure: Incidence of treatment-emerged adverse events in the two glucocorticoid regimens groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: University Hospital of Endocrinology
Study officials:
affiliation: Medical University of Sofia: Medicinski universitet-Sofia
name: Mariya D Stoynova, PhD
role: PRINCIPAL_INVESTIGATOR
References: