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临床试验/NCT02164214
NCT02164214已完成3 期

DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)?

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
serum levels of soluble TWEAK

研究概览

简要总结

TWEAK (TNF weakly inducer of apoptosis) is a type II-transmembrane protein, member of the TNF ligand superfamily that can be cleaved to function as a soluble cytokine. Depending on target cell type, TWEAK triggers multiple cellular responses ranging from modulation of inflammation to cell death when it binds to its main receptor, Fn 14. Our team has been the first to describe pro-inflammatory effects of TWEAK during central nervous system inflammation. Various data support the possibility that TWEAK produced by synovial macrophages may contribute to chronic synovitis in animal models and in humans. In psoriatic arthritis (PsoA), anti-TNF therapy has been successful concording with the key role of TNF in the pathogenesis of this disease and the generation by psoriatic patients of neutralizing anti-TNF autoantibodies referred as "beneficial autoimmunity to pro-inflammatory mediators". In 2010, Van Kuijk et al. have described a high expression of TWEAK in the inflammatory synovial of PsoA and rheumatoid arthritis (RA) patients before and after anti-TNF therapy. The role of TNF-alpha in the regulation of TWEAK expression remains unclear.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

  • · Group RhPso :
  • Fill(Perform) the criteria CASPAR of the Rheumatism psoriasic (Taylor W, on 2006)
  • rheumatoid Absence of factor and antibody anti-CCP(anti-post office account) (cyclic citrulline peptide) in the serum
  • Indication established to begin a treatment with etanercept
  • Fill(Perform) the criteria of the ACR (American College of Rheumatology) for PR (revised in 1987) (Arneth FC, on 1988)
  • Presence of antibody anti-CCP(anti-post office account) in the serum
  • Indication established to begin a treatment with etanercept

排除标准

  • Minors(Miners)
  • pregnant or breast-feeding Women
  • Adults under guardianship
  • Nobody staying in a sanitary or social establishment
  • Persons in emergency situation and/or not beneficiaries of a national insurance scheme
  • Private persons of freedom
  • Arthritis or not labelled polyarthritis
  • Contraindication established in the treatment(processing) by etanercept
  • PUVAthérapie or cyclosporine or high dose of corticosteroid therapy (except intra-articular infiltration) or other anti-TNF treatment(processing) in two months preceding the inclusion

研究组 & 干预措施

patients PSORIATIC ARTHRITIS

Experimental

etanercept Treatment

干预措施: etanercept Treatment (Drug)

patients RHEUMATOID ARTHRITIS

Active Comparator

etanercept Treatment

干预措施: etanercept Treatment (Drug)

结局指标

主要结局

serum levels of soluble TWEAK

时间窗: 42 months

samples blood before and after etanercept 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

研究点 (1)

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