ISRCTN22471573已完成未知
Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease
niversity of Bristol (UK)0 个研究点目标入组 100 人开始时间: 2006年2月1日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
- 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18237441 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29396245
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Mourits' Clinical Activity Score more than or equal to four (worst eye) or more than two (worst eye) with a history of proptosis (defined as either subjective unilateral proptosis confirmed by asymmetry in exophthalmometry of more than 2 mm or subjective bilateral proptosis) or motility restriction (defined as intermittent, inconstant or constant diplopia grade) which is less than six months long
- •2. Past or present history of abnormal Thyroid Gland Function (TGF) or a clinical diagnosis of TED made and confirmed by more than two muscle involvement on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan plus a history of recent onset motility restriction and/or proptosis
排除标准
- •1. Age less than 20 or greater than 75 years
- •2. Optic neuropathy
- •3. Mourits? Clinical Activity Score more than four without proptosis or motility restriction
- •4. Pre-existing glaucoma with a characteristic optic disc appearance and associated visual field defect
- •5. Use of radioiodine within the last three months
- •6. Pre-existing diabetes mellitus (not simply steroid-induced disease from recent therapy)
- •7. Previous adverse event associated with, or contraindication to, either prednisolone or azathioprine
- •8. Within six months of pregnancy, women planning pregnancy
- •9. Lactation
- •10. Haemoglobin concentration, total white cell count or platelet count below the local laboratory's reference range
- •11. Low, intermediate or high Thiopurine Methyltransferase (TPMT) activity
- •12. Lymphocyte count less than 0.8 x 10^9/l
- •13. Abnormal renal function (assessed by urea and creatinine levels above the local laboratory?s reference range)
- •14. Abnormal liver function, specifically: bilirubin, alanine aminotransferase or alkaline phosphatase concentrations above the local laboratory?s reference range
- •15. Malignant or pre-malignant (dysplastic) condition within the past five years
- •16. Previous tuberculosis
- •17. Shingles within the past three months
- •18. Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS)
- •19. Concurrent use of:
- •a. Other immunosuppressive or cytotoxic agents
- •b. Allopurinol
- •20. Live vaccines within the past three months
- •21. Previous orbital irradiation
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