跳至主要内容
临床试验/NCT05767801
NCT05767801进行中(未招募)不适用

Synovial Tissue and Blood Signature to Personalize the Management of Rheumatoid Arthritis Patients With Disease Flare After Biological DMARDs Discontinuation for Sustained Remission.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
3
主要终点
Disease flare rate

研究概览

简要总结

Flares of immune-mediated inflammatory diseases, as Rheumatoid Arthritis (RA), are a major burden for patients in routine care. They occur unpredictably, adding to the physical and psychological burden of the condition. In this study we will deeply dissect the synovial tissue and peripheral blood signature of RA in sustained remission eligible to treatment discontinuation to better understand the individualized factors determining disease flare once biological treatment is discontinued. We expect that the combined study of synovial tissue, imaging and peripheral blood derived biomarkers, associated with disease flare after treatment discontinuation in RA in remission, will provide a tool for the routine assessment of RA eligible to treatment discontinuation reducing the relapse rate and increasing the optimization of the use of expensive pharmacological treatments only for patients still needing them.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of RA following the 2010 ACR/EULAR classification criteria
  • Age ≥18 and ≤75 years
  • Sustained remission (DAS<1.6 for at least 3 sequential evaluations 6months apart).
  • Without evidence of ultrasound detected synovitis (Power Doppler negative in knee, wrist, II-V MCP, II-V PIP and II-V MTP bilaterally).
  • Patients under treatment with stable dose of conventional, synthetic or biological DMARDs.
  • Patients without steroid treatment in the last 6 months.

排除标准

  • With other diagnosis of chronic joint diseases rather than RA.
  • Unable to participate to the clinical outpatient follow-up.
  • Exposed to steroid treatment within 6 months from study screening.
  • With evidence of ultrasound detected synovitis (Power Doppler positivity) in other joints than the ones included in the screening visit.

结局指标

主要结局

Disease flare rate

时间窗: 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alivernini Stefano

MD, PhD

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (3)

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