Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to a DMARD Starting a New bDMARD or tsDMARD Treatment +/- csDMARD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,410
- 试验地点
- 43
- 主要终点
- Clinical Response Prediction
研究概览
简要总结
The primary goal of this study is to assess a cfDNA-based blood test using genetic, transcriptomic and/or epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (RA) patients with inadequate response or intolerance to previous therapies.
详细描述
PRIMA - 102 aims to predict response to bDMARD or tsDMARD therapy through analysis of cfDNA in blood. PRIMA - 102 will enroll participants with inadequate response or intolerance to previous therapies. Participants will undergo screening and baseline visits, followed by the initiation of new bDMARD or tsDMARD therapy per standard of care. The study will evaluate treatment response and disease activity at a 12-week follow-up visit. Blood will be drawn and Clinical Outcome Assessments performed at baseline and at the 12-week follow-up visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Ability to understand and provide written informed consent.
- •Male or female ≥18 years of age at enrollment.
- •Diagnosis of Rheumatoid Arthritis at the time of enrollment.
- •Prior treatment with at least 1 csDMARD, bDMARD, or tsDMARD
- •Planning to initiate a new bDMARD (+/- csDMARD) or tsDMARD (+/- csDMARD), within 1 month after enrollment.
- •Moderate to high Clinical Disease Activity Index (CDAI) of (>10) with a minimum 4 tender joints and 4 swollen joints at the time of screening.
排除标准
- •Unsuitable for participation in the opinion of the principal investigator.
结局指标
主要结局
Clinical Response Prediction
时间窗: Approximately 3 months
This study aims to identify cfDNA signatures that predict response to specific bDMARD or tsDMARD therapies for RA treatment.
次要结局
未报告次要终点