跳至主要内容
临床试验/NCT05592574
NCT05592574招募中不适用

Feasibility of an Il-17a Assay and Impact on Therapeutic Response in Patients With Active Axial Spondyloarthritis

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.

研究概览

简要总结

There are, to date, no validated biomarkers or head-to-head RCTs of biologics to guide choice of biologic agent in axSpA. While there are now two head-to-head studies of a TNF inhibitor (TNFi) vs an IL-17 inhibitor (IL-17i) in psoriatic arthritis. Recommendations refers to biological DMARDs (bDMARDs) including TNFi and IL-17i for patients with high disease activity despite the use (or intolerance/contraindication) of at least two non-steroidal anti-inflammatory drugs (NSAIDs) in axial SpA (axSpA) and in failure of a strategy including methotrexate for psoriatic arthritis. A tool to help us to decide which bDMARDs to use is necessary.

In SpA, the method of determination of IL17 seems to be questionable.

The determination of cytokines after stimulation of immune cells in patients with active SpA requiring a biological treatment could provide us with a tool to assist in the choice of therapy.

The aim of the study was to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment. And secondly, to show the predictive character of this expression on the therapeutic response at three months after the implementation of a biological treatment.

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 90 Years(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

to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.

时间窗: 18 months

rate of IL17

次要结局

  • predictive value of IL17 rate(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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