JPRN-jRCT2071230031招募中3 期
A MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND PHASE III CLINICAL TRIAL OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
Yoshiya Tanaka0 个研究点目标入组 24 人开始时间: 2023年6月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
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
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1)Patients living in Japan aged 18-75 years
- •(2)Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria >12 weeks prior to screening
- •(3)ANA >1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN)
- •(4)Low C3 and/or low C4 and/or low CH50 complement
- •(5)High disease activity at screening, as defined by all of the following:
- •-BILAG-2004: Category A disease in >1 organ system and/or Category B disease in >2 organ systems
- •-SLEDAI-2K: score >8
- •-Physician`s Global Assessment (PGA): score >1.0 on a 0 to 3 Visual Analog Scale (VAS)
- •(6)Current receipt of >1 of the following classes of standard therapies for the treatment of SLE at stable doses: OCS, antimalarials, conventional immunosuppressants
排除标准
- •(1)Presence of significant lupus-associated renal disease and/or renal impairment
- •(2)Active severe or unstable lupus-associated neuropsychiatric disease
- •(3)Receipt of any of the following excluded therapies:
- •-Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy such as, but not limited to, obinutuzumab, rituximab, ofatumumab, or bortezomib less than 9 months prior to Day1
- •-Cyclophosphamide less than 3 months prior to Day1
- •-Calcineurin inhibitor (ciclosporin, voclosporin) less than 4 weeks prior to Day1
- •-Any biologic therapy (drugs other than B cell or plasma cell depleting drugs that may affect the safety of subjects or evaluation of this study) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept less than 2 months prior to Day1
- •-Any live vaccine less than 28 days prior to Day1
研究者
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