JPRN-jRCT2080221083未知3 期
Double-blind, Parallel, controlled Phase III Study of MRA-SC in Patients with Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 330
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 <= 75age old（—）
- 性别
- All
入选标准
- •Patients with RA diagnosed according to the revised 1987 ACR criteria. CRP or ESR at screening is >1mg/dL or >30 mm/h, respectively.
- •Non responder or inadequate response patients who receive at least one DMARD,immunosuppressant and Biologic DMARDs.
排除标准
- •1)Patients who are treated with inflizimab , etanercept or adalimumab within 12 weeks before treatment.
- •2)Patients for whom the following criteria apply in tests conducted within two weeks before
- •treatment with the investigational product.
- •-WBC count:< 4000/uL
- •-Neutrophil count:<1000/uL
- •-Lymphocyte count:< 500/uL
- •-Platelet count:<10 x 104/uL
- •3) Patients who have been treated with any of the following within four weeks before treatment with the investigational product. DMARDs or immunosuppressants where the dosage regimen was changed.
研究者
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