Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves' Orbitopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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:
- Are the two glucocorticoid regimens similarly effective?
- 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.
详细描述
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:
- Are the two glucocorticoid regimens similarly effective?
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active moderate-to-severe Graves' orbitopathy
- •Without previous treatment with glucocorticoids or orbital radiotherapy
- •Euthyroid state
排除标准
- •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
研究组 & 干预措施
Modified monthly regimen
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.
干预措施: Methylprednisolone (Drug)
Weekly regimen
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.
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
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
时间窗: 6 months
Comparison of the changes in clinical activity score, assessed using a 7-point scale at baseline or 10-point scale during the follow-up and expressed in points as recommended by European Thyroid Association and European Group on Graves' orbitopathy during the treatment with the two glucocorticoid regimens
Comparison of the changes in proptosis expressed in mm during the treatment with the two glucocorticoid regimens
时间窗: 6 months
Comparison of the changes in proptosis measured by Hertel's exophthalmometer and expressed in mm during the treatment with the two glucocorticoid regimens
Comparison of the changes in lid aperture expressed in mm during the treatment with the two glucocorticoid regimens
时间窗: 6 months
Comparison of the changes in lid aperture measured by ruler and expressed in mm during the treatment with the two glucocorticoid regimens
Comparison of the changes in the overall therapeutic response assessed using Bartalena's criteria during the treatment with the two glucocorticoid regimens
时间窗: 6 months
Comparison of the changes in the overall therapeutic response assessed using Bartalena's criteria and classified as full, partial and no response during the treatment with the two glucocorticoid regimens
Comparison of the changes in diplopia assessed using Gorman's classification system during the treatment with the two glucocorticoid regimens
时间窗: 6 months
Comparison of the changes in diplopia assessed using Gorman's classification system and classified as gr. 0 absent, gr. I intermittent, gr. II inconstant, gr. III constant during the treatment with the two glucocorticoid regimens
Comparison of the changes in visual acuity expressed in decimals during the treatment with the two glucocorticoid regimens
时间窗: 6 months
Comparison of the changes in visual acuity measured by Snellen chart and expressed in decimals during the treatment with the two glucocorticoid regimens
Incidence of treatment-emerged adverse events in the two glucocorticoid regimens groups
时间窗: 6 months
Number and type of adverse reactions in the study groups reported by patients themselves or found by the laboratory tests or during clinical examination.
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
时间窗: 6 months
Comparison of the changes in quality of life during the treatment with the two glucocorticoid regimens assessed by disease-specific questionnaire recommended by European Group on Graves' orbitopathy (GO-QoL) аnd expressed as percentages, which includes two subscales - one evaluating the impact of Graves' orbitopathy on patients' visual functioning (QoL-VF) and the other related to the changes of physical appearance as a result of the disease (QoL-AP)
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
时间窗: 6 months
Comparison of the changes in soft tissue involvement evaluated using the colour atlas proposed by European Group on Graves' orbitopathy and categorized as gr. 0-I absent or mild, gr. II-III moderate or severe during the treatment with the two glucocorticoid regimens
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
时间窗: 6 months
Comparison of the changes in subjective symptoms whose severity was reported by patients themselves and were graded as 0-I absent or mild, gr. II-III moderate or severe during the treatment with the two glucocorticoid regimens
次要结局
未报告次要终点
研究者
Mariya Stoynova
Principal investigator
Medical University of Sofia