EUCTR2010-018289-21-CZ进行中（未招募）1 期
Clinical, laboratory and ultrasound markers for the prediction of the response on the pulse-dose treatment by intravenous glucocorticoids in patients with endocrine orbitopathy
Insitute of Endocrinology0 个研究点目标入组 45 人开始时间: 2010年1月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Pacients with active and moderate to severe or sight threatening endocrine orbitopathy (EO), age more than 18 years, laboratory positivity of autoantibodies against TSH receptor, patological monitored parameters for the ultrasonographical examination of the orbit.
- •Activity is maesured on the classical features on inflamantion: clinical activity score (CAS). CAS more tahn 4 indicates active EO.
- •Moderate to severe EO: Patients usualy have any one or more of the following: lid retraciton more than 2 mm, moderate or severe soft tissue involvement, exophthalmos more than 3 mm above normal for race and gender, inconstant, or constant diplopia.
- •Sight threatening EO: Patients with dysthyroid optic neuropathy and/or corneal breakdown.
- •Monitored parameters for the ultrasonographic examination of the orbit: thickness of the medial, lateral and inferior direct eye muscle and thickness of the upper muscle group - superior direct with eyelid levator - lateral and inferior, according to an arbitrary scale established by us the muscle echogenicity - I to IV, where I is a normal orbital muscle, i.e. deeply hypoechogeneic, IV is of the echogenicity as high that it is barely undistinguishable from surrounding connective tissue. Measurement of the flow rates especially in the arteria centralis retinae, artheries cilliares breves and in artheria ophthalmica.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •hypersensitivity, TBC (patients with active disease and latent disease, including positive tuberculin test, which need careful monitoring for possibility of reactivation of disease and requirements of chemoprophylaxis), systemic mycosis, active peptic ulcer, fresh intestinal anastomoses, decompensated diabetes mellitus, severe heart insuficiency, severe uncorrected hypertension, psychosis (acute or in medical history), severe impairment of renal function, active hepatitis, gravidity, lactation, inability to sign the informed consent.
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