JPRN-jRCT1091220325招募中2 期
Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ
Masayoshi Harigai0 个研究点目标入组 48 人开始时间: 2018年1月23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
- >= 20age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1 Those with ANCA positive active MPA or GPA according to the diagnostic criteria of Japanese MHLW, or those with ANCA positive pauci-immune glomerulonephritis without non-renal vasculitis. They must have newly diagnosed MPA or GPA, or have a disease flare that fulfills the inclusion criteria.
- •2 They must be 20 years of age or older and be under 80 years old.
- •3 They must weigh at least 40 kg.
- •4 They must have active disease with BVAS v3 more than 3 with one or more of the major BVAS items. Or they must have active disease severe enough to require treatment with CY (i.e., an organ threatening disease if not treated appropriately) according to the discretion of site investigators.
- •5 Serum C-reactive protein level must be grater than1.0 mg/dl.
- •6 They must be willing to practice medically acceptable contraception until 70 days after the last administration of TCZ and until 90 days after the last administration of IVCY or AZA.
- •7 For female participants, they must be willing to refrain from breastfeeding throughout the trial.
- •8 They must be willing to comply with study procedures, including completion of all visits and treatments
- •9 They must be willing and able to provide informed consent.
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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