跳至主要内容
临床试验/NCT03975361
NCT03975361Unknown不适用

Tolerance Checkpoints Upon the B-cell Depletion Plus BAFF Blockade Strategy in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) (Checkpoints ITP and SLE)

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年4月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood

研究概览

简要总结

The aim of this proposal is to test if anti-BAFF antibody can restore a normal threshold of tolerance in patients in two auto-immune diseases along the RITUX-PLUS study in immune thrombocytopenia, and along the Believe study in SLE. This work would help to conclude whether or not the 'double hit' therapy may help to reset the immune system toward a more tolerogenic profile.

The aim is to compare the polyreactivity and autoreactivity, of immature (central tolerance) and naïve B cells (peripheral tolerance) in the peripheral blood along the RITUX-PLUS STUDY and the BLISS BELIEVE study after treatment (B-cell reconstitution time).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood

时间窗: 1 year

Number of polyreactive and autoreactive cells in immature (central tolerance) and naïve B cells (peripheral tolerance) subsets in the peripheral blood along the RITUX-PLUS and the BLISS BELIEVE studies after treatment (reconstitution time).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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