NCT05161234已完成不适用
A Clinical Utility Study of PrismRA Testing Therapeutic Response for Rheumatoid Arthritis (DRIVE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 613
- 试验地点
- 30
- 主要终点
- Therapeutic Response
研究概览
简要总结
A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 at time of consent
- •Patient must meet the criteria for RA as defined by the 2010 ACR/EULAR classification at Visit 1
- •Patient has active, moderate to high, RA with a CDAI of >10 at Visit 1
- •Patient has swollen and tender joint count of ≥ 2 each, as determined by CDAI assessment at Visit 1 using a 28-joint count
- •Patient may participate in additional observational studies concurrently
- •Patient is willing and able to complete the informed consent process and comply with study procedures and visit schedule
排除标准
- •Patients who are unable to understand the protocol and unable to provide informed consent
- •Patients who are not indicated for PrismRA
- •Patients who are receiving concurrent treatment with an investigational therapy or have used an investigational therapy less than 4 weeks prior to Visit 1
结局指标
主要结局
Therapeutic Response
时间窗: 12-or 24-weeks
Proportion of moderate to severe disease activity patients that achieve measurable clinical outcomes therapeutic response after initiation of a non-csDMARD therapy
次要结局
未报告次要终点
研究者
研究点 (30)
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