Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Establishment of cellular and molecular atlas of remission RA
研究概览
简要总结
The FLARE-RA study will have the following research objectives:
A) To establish the cellular and molecular atlas of remission RA achieved with different therapeutics aimed to identify (i) cell clusters/pathways driving disease flare or maintaining remission and (ii) provide an evidence base for developing ML tools for predicting flares.
B) To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.
C) To dissect the cellular and molecular mechanisms of remission maintenance and joint flares.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid Arthritis classified based on the 2010 EULAR/ACR Classification Criteria
- •Stable treatment with cDMARDs and/or bDMARDs (≥12 months)
- •Stable remission status (at least DAS28-CRP<2.6) (≥6 months)
- •No concomitant steroid treatment (≥6 months)
- •Absence of Power-Doppler signal at ultrasound assessment (wrist, MCP, PIP, Knee, ankle and II-V MTP bilaterally) in 3 evaluations 3 months apart.
排除标准
- •DAS28-CRP≥2.6
- •Presence of Power-Doppler signal ≥1 at ultrasound assessment (wrist, MCP, PIP, Knee, ankle and II-V MTP bilaterally)
- •Other chronic inflammatory disease
结局指标
主要结局
Establishment of cellular and molecular atlas of remission RA
时间窗: months 1-12
To establish the cellular and molecular atlas of remission RA achieved with different therapeutics aimed to identify (i) cell clusters/pathways driving disease flare or maintaining remission and (ii) provide an evidence base for developing ML tools for predicting flares.
次要结局
- To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.(months 13-36)
- To dissect the cellular and molecular mechanisms of remission maintenance and joint flares(months 13-36)