跳至主要内容
临床试验/NCT04360772
NCT04360772撤回不适用

Monitoring of Corticosteroids Induced Immunosuppression Using mHLA-DR

Hospices Civils de Lyon0 个研究点开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Kinetics of mHLA-DR expression determined by flow cytometry before treatment and during the 6 first months of degressive corticosteroids doses

研究概览

简要总结

Corticotherapy is widely used in auto-immune diseases. If induced immunosuppression by corticosteroids is well admitted, it's currently not possible to determine individual risk of infection. Thus, the development of new biomarkers able to reflect immunological status under immunosuppressive treatments is needed. It would help identifying patients who would benefit from adapted treatment protocols or infectious prophylaxis. In this field, the mHLA-DR (monocyte Human Leukocyte Antigen-DR) has shown encouraging results. However, it has never been used in patients treated by immunosuppressive therapies. The investigators aim to describe changes induced by corticosteroids in mHLA-DR expression in vivo. To achieve this goal, the investigators will measure mHLA-DR before treatment, after 1 months, 3 months and 6 months of treatment. Finally, the investigators will look for correlation between the level of expression of mHLA-DR and the cumulated dose of corticosteroids administered.

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

  • Patient aged of 18 years old or more, male or female.
  • Patient diagnosed with any pathology indicating a treatment by corticotherapy at 1mg/kg/day.
  • Patient who didn't express any opposition to be enrolled in the study after reading the dedicated information letter.
  • Patient affiliated to social heath care regimen

排除标准

  • Treatment by corticosteroids in the previous 6 months.
  • Immunsuppressive treatment (except for corticosteroids) in the previous 2 years.
  • Patient under judicial protection, guardianship or curators

结局指标

主要结局

Kinetics of mHLA-DR expression determined by flow cytometry before treatment and during the 6 first months of degressive corticosteroids doses

时间窗: Month 1, 3 and 6

mHLA-DR expression level will be compared between : * Before treatment and at 1 month of treatment * Before treatment and at 3 months of treatment * Before treatment and at 6 months of treatment * 1 month and 3 months of treatment * 1 month and 6 months of treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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