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临床试验/NCT03416543
NCT03416543已完成不适用

Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Production of IL-10

研究概览

简要总结

First, this study will evaluate, in vitro, the cellular composition of the synovial fluid from patient with rheumatoid arthritis, gout or osteoarthritis.

Then samples will be test with a new format of bispecific antibody targeting dendritic cells. The production of IL-10 will be the principal criteria of judgment. Production of others cytokines like IL-1B, IL-6, IL-12 and IFN will be checked as well.

详细描述

Rheumatoid arthritis (RA) is one of the most common autoimmune disease in adult. It exists several drugs but none target dendritic cells even if it seems they play a major role in the physiopathology.

One of the unit of research of Tours recently develop a new format of bispecific antibody which target dendritic cells. The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with RA and patients with gout (for the comparison, because the inflammatory mechanisms are different) and with osteoarthritis (comparison with a non inflammatory disease) Then, we will use this new antibody and evaluate the response by dosing Il-10, IL-6, IL-12, IL1B and IFNy The aim is to verify in vitro if, with this new drug, it is possible to reverse the inflammation and induce a tolerance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Male or female over 18 years old
  • Proven and possible RA or Gout or osteoarthritis
  • Arthritis accessible to a puncture
  • Necessary puncture for diagnosis or therapeutic

排除标准

  • Microcrystalline rheumatism other than Gout
  • Known SpA
  • Septic arthritis
  • Biomedicament treatment
  • Patient having objected to the processing of his data

结局指标

主要结局

Production of IL-10

时间窗: 48 hours

Evaluate the production of IL-10 by cells from synovial fluid after the use of a new antibody format

次要结局

  • Production of Il-6(48 hours)
  • Production of IFN(48 hours)
  • Production of IL1B(48 hours)
  • Production of IL12(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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