JPRN-jRCT2080220984未知2 期
A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)
适应症
试验速览
- 阶段
- 2 期
- 发起方
- AstraZeneca
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
- •Patients must have previously met 4 or more of the 11 revised ACR criteria
- •-Have positive antinuclear antibody test (ANA) at 1:80 serum dilute or more in the past or at screening
- •-Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score 6 or more
排除标准
- •-Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)
- •-Have received the following medications within 28 days before Visit 2 (Day 1):
- •- Systemic cyclophosphamide at any dose
- •- Cyclosporine at any dose
- •- Tacrolimus at any dose
- •- Thalidomide at any dose
- •- Mycophenolate mofetil >2 g/day
- •- Methotrexate >15 mg/week
- •- Azathioprine >2 mg/kg/day
- •-Women who have a positive pregnancy test (serum hCG) at Visit 1
研究者
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