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临床试验/NCT02747277
NCT02747277已完成不适用

Analysis of B Cells From Autoimmune Individuals

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Frequency of CD19 and IgM low B cells in cord blood of babies born from autoimmune mothers

研究概览

简要总结

This observational study aims at finding out if individual with autoimmunity exhibit increased numbers of B cells that express two types (instead of one type) of antibodies, and if B cells of individuals genetically susceptible to autoimmunity display defects in the biological process of tolerance, which removes B cells that participate in autoimmunity.

详细描述

Peripheral blood B cells of SLE patients are analyzed by flow cytometry to determine the frequency of B cells co-expressing immunoglobulin kappa an lambda light chains. This frequency is correlated to the disease activity.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Males and Females diagnosed with Lupus;
  • Adult Females who are pregnant and diagnosed with:
  • lupus erythematosus
  • rheumatoid arthritis, or
  • type 1 diabetes.

排除标准

  • Adult males or adult females treated with B-cell depletion therapies.

结局指标

主要结局

Frequency of CD19 and IgM low B cells in cord blood of babies born from autoimmune mothers

时间窗: 1 day

For cord blood samples, the main outcome measurement is the frequency of B cells that express both low levels of CD19 and IgM within the total (CD19+ or CD20+) B cell population. The collected data will be aggregated as the average frequency of CD19low/IgMlow B cells in subjects that were born from autoimmune mothers relative to those born from healthy mothers. Moreover, data will also be stratified in respect to the presence or absence of the PTPN22-R620W allele, which is a risk allele for autoimmunity.

Frequency of kappa to lambda ratios of B cells in blood of autoimmune adults

时间窗: 1 day

For peripheral adult blood, the main outcome measure is the frequency of κ/λ (kappa to lambda ratios) dual immunoglobulin B cells within the overall B (CD19+ or CD20+) cell population. The collected data will be aggregated as the average frequency of κ/λ B cells in subjects with autoimmunity relative to healthy controls.

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 (1)

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