JPRN-jRCT2080221821未知1 期
A Phase I study of rontalizumab
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 21
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 <= 64age old（—）
- 性别
- All
入选标准
- •(1)Diagnosis of SLE based on meeting at least 4 of 11 of the 1997 American College of Rheumatology (ACR) classification criteria prior to informed consent and duration of SLE of >/= 12 months.
- •(2)For patients with reproductive potential (males and females), able to use a reliable means of contraception
- •(3)For female patients, uterine cervical cytology results of cytology class II or below confirmed on uterine cervical cancer testing.
排除标准
- •(1)Received >20 mg/day or 0.5 mg/kg/day (body weights <40 kg) prednisolone equivalent corticosteroids for >/= 4 days within 30 days prior to informed consent
- •(2)Received any of the drug below or transfusions within three months prior to informed consent
- •- pulse dose corticosteroids,
- •- azathioprine,
- •- mizoribine,
- •- methotrexate,
- •- mycophenolate mofetil,
- •- cyclosporine,
- •- tacrolimus,
- •- sirolimus,
- •- monoclonal antibody
- •- intravenous immunoglobulin (IVIG)
- •(3)Received cyclophosphamide within two years prior to informed consent
- •(4)Previously received another study drug directed against IFNalpha
- •(5)History of B-cell depleting therapy or anti-BLYS therapy within 12 months prior to informed consent
研究者
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