EUCTR2008-002123-93-DE进行中（未招募）不适用
Mycophenolate sodium in Graves’ orbitopathy - MINGO
Johannes Gutenberg-Universität0 个研究点目标入组 150 人开始时间: 2009年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •1.Euthyroidism for at least 2 months with antithyroid drugs or following thyroidectomy, or 6 months following radioiodine administration
- •2.Active GO: Clinical Activity Score, CAS = 3 out of 7
- •3.Moderately severe GO: at least one of the following signs:
- •-Moderate to severe active soft tissue involvement, also according to color atlas evaluation
- •-Proptosis = 22 mm
- •-Eye muscle involvement with mono-ocular ductions in any direction of gaze of less than 30° or evident dismotility
- •-Diplopia according to Gorman score of grades a-c
- •4.No previous immunosuppressive treatment for GO
- •5.Age: 18-75 years
- •6.Effective method of contraception during the whole trial and at least six weeks after last intake of trial drugs
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •2.Optic neuropathy
- •3.Pregnancy, breast-feeding women
- •4.No informed consent
- •5.Acute or chronic viral hepatitis
- •6.Relevant Malignancy
- •7.Chronic renal failure (GFR < 30)
- •8.Corticosteroids or other immunosuppressive agents within last 3 months
- •9.Recent history of alcoholism or drug abuse
研究者
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