Synovial Tissue and Blood Signature to Personalize the Management of Rheumatoid Arthritis Patients With Disease Flare After Biological DMARDs Discontinuation for Sustained Remission.
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
- 是
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
Alivernini Stefano
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
