Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Index Characterization
研究概览
简要总结
The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.
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
- 5 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible for inclusion in the study, an individual must meet all of the following criteria:
- •Male or female ≥ 5 years of age at screening.
- •Documentation of a JIA, SLE or FM diagnosis as evidenced by history
排除标准
- •Any individual who meets any of the following criteria will be excluded from participation in this study:
- •Documented history of eye disease precluding pupillometry
研究组 & 干预措施
SLE
Patients ages 5-21 with a diagnosis of SLE.
干预措施: No Intervention (Other)
JIA
Patients ages 5-21 with a diagnosis of JIA.
干预措施: No Intervention (Other)
FM
Patients ages 5-21 with a diagnosis of FM.
干预措施: No Intervention (Other)
结局指标
主要结局
Index Characterization
时间窗: 1 Year
The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations.
次要结局
- Treatment Effect(1 Year)
研究者
Julia Finkel
Professor of Anesthesiology and Pediatrics
Children's National Research Institute
