Treatment of Graves' Orbitopathy in Patients Failing Corticosteroid Therapy: Multicenter National Retrospective Study- Basedow
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Response to second-line basedow treatment
研究概览
简要总结
Describe the progression of inflammatory orbitopathy and the biological progression of patients receiving second-line treatment (immunosuppressants, radiotherapy, or biotherapy).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Patients aged 18 and older with moderate to severe orbitopathy;
- •Patients followed in endocrinology with the goal of achieving euthyroidism;
- •Corticosteroid-resistant patients: patients who have received at least 3 weeks of treatment with 500 mg weekly corticosteroid boluses and have not shown improvement in the clinical activity score (CAS);
- •Corticosteroid-dependent patients: relapse with a CAS of 3 or higher when decreasing or stopping corticosteroid therapy;
- •Patients with a CAS ≥ 3 or CAS <3 with moderate to severe orbitopathy (according to EUGOGO);
- •Patients treated with immunotherapy, biotherapy, or radiotherapy as second-line treatment;
- •Patients who are not opposed to the reuse of their health data.
排除标准
- •Patients who have undergone bone or fat decompression surgery;
- •Patients with severe corneal involvement (Grade B or C; NO SPECS classification);
- •Patients with optic neuropathy (Grade B and C; NO SPECS classification);
- •Patients who have received 1 gram corticosteroid boluses for dysthyroid orbitopathy;
- •Patients who have opposed the reuse of their health data.
结局指标
主要结局
Response to second-line basedow treatment
时间窗: Patients who started a second-line treatment between January 2022 and December 2023, with clinical follow-up until the end of 2024, were included in order to minimize selection bias. inclusion period: until december 2025
Practices in France regarding the use of these second-line treatments appear to be heterogeneous, and their effectiveness has never been compared through randomized studies. investigators propose to collect and analyze the therapeutic outcomes of second-line treatment in patients with Graves' orbitopathy. The data collection concerns patients with Graves' orbitopathy who have received corticosteroid therapy and a second-line treatment (immunosuppressant, biotherapy) since 2022. Data from the medical records of patients included.
次要结局
未报告次要终点