JPRN-jRCTs071180052招募中2 期
Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - None
akashima Yasuharu0 个研究点目标入组 150 人开始时间: 2019年3月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Objectives must have been classified as systemic lupus erythematosus (SLE) based on the classification criteria of the American College of Rheumatology.
- •(2) Objectives need a systemic corticosteroid treatment of a dose of equal to or more than 0.5mg/kg/day (converted to prednisolone dose) for SLE.
- •(3) Objectives are hospitalized.
- •(4) Objectives are the age of 20 or more.
- •(5) Objectives have consented to participate in the study after fully informed.
- •(6) Objectives that the laboratory data meets all the following.
- •i) Patients with more than 70,000/microL of platelets.
- •ii) Patients with less than 100IU/L of AST or ALT.
- •iii) Patients with more than 50ml/min of creatinine clearance.
排除标准
- •(1) Objectives have never had corticosteroid treatment before the entry to the trial.
- •(2) Objectives have never been affected with osteonecrosis of the femoral head.
- •(3) Patients with any active bleeding lesion.
- •(4) Patients with any active infection.
- •(5) Patients have any contraindication to candidate drugs for prevention.
- •(6) Patients have any past histories of anaphylaxis to test drugs for prevention.
- •(7) Female in pregnancy, lactation period, having a possibility of pregnancy.
- •(8) Patients taking below contraindicative drugs.
- •1. antiplatelet drugs expect clopidogrel
- •2. anticoagulant
- •3. fibrates
- •4. cyclosporine
- •(9) Patients that have a contraindication for MRI.
- •(10) Patients that are considered unsuitable for the entry to the trial.
研究者
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