JPRN-UMIN000024574招募中2 期
Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ
Tokyo women's medical university Institute of rheumatology0 个研究点目标入组 48 人开始时间: 2017年5月1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
- 48
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
- 20years-old 至 85years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Exclusion Criteria Patients who meet any of these criteria will not be enrolled in this study: Eosinophilic granulomatosis with polyangiitis or anti-glomerular basement membrane antibody disease patients. Other collagen diseases or systemic autoimmune diseases patients. Severity: limited disease according to EUVAS criteria. Those having serious lung, renal or heart disease. Those having infarction or bleeding of gastrointestinal tract or having diverticulitis.. Those having a history of severe drug allergic reactions. Those having an active infection or a deep-seated infection within 6 months of randomization. Those having active hepatitis B or a history of infection with HBV. Those having positive anti-HBs antibody or anti-HBc antibody, and HBV-DNA. Those having active hepatitis C or a history of hepatitis C. Those having an ALT or AST level greater than 2.5 times of the upper limit of normal. Those having active tuberculosis or mycosis Those having CMV antigenemia They have or have a history of malignancy, leukemia, lymphoma or lymphoproliferative disease in the past 5 years. Those having uncontrolled other disease. Those having a white blood cell count less than 4,000/mm3 or a platelet count less than 120,000/mm3. Those who have received TCZ or other biological agents. Those who were intolerant to CYC or AZA. Those who started GC or increased a dosage of GC within 4 weeks prior to enrollment. Those who started GC at or increased a dosage of GC to a prednisone-equivalent dose greater than 25mg per day between 5 and 8weeks prior to enrollment. Those who started or increased a dosage of immunosuppressive agents except for GC within 8 weeks prior to enrollment. Those who were treated with plasma exchange or IVIG within 4 weeks prior to enrollment. Those who received a live vaccine within 4 weeks prior to enrollment. Those who were enrolled in another clinical trial and received an investigational agent within 12 weeks prior to enrollment.
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