A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 368
- 试验地点
- 140
- 主要终点
- Demographic characteristic of participants who receive dupilumab for EoE: Age
研究概览
简要总结
This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab).
The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE.
Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward.
Patient questionnaires will measure the following:
- How EoE makes one feel
- EoE signs and/or symptoms, eg, how difficult it is to swallow
- How EoE affects quality-of-life
- How EoE impacts aspects of daily life
- How EoE symptoms have changed throughout the study
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initiating treatment with DUPIXENT® for EoE according to the USPI
- •Participants aged ≥12 years and caregivers or legal guardians of participants aged <12 years must be able to understand and complete registry-related questionnaires
排除标准
- •Patients who have a contraindication to DUPIXENT® according to the USPI
- •Treatment with DUPIXENT® within the 6 months prior to the screening assessment
- •Participation in an ongoing interventional study on or within 6 months of the baseline assessment. Once enrolled in registry, participation is allowed in other ongoing studies (at the discretion of the registry investigator)
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
EoE Patients treated with DUPIXENT®
干预措施: dupilumab (Drug)
结局指标
主要结局
Demographic characteristic of participants who receive dupilumab for EoE: Age
时间窗: Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Esophagogastroduodenoscopy (EGD)
时间窗: Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Dietary interventions
时间窗: Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Medical history
时间窗: Baseline and up to 3 years after treatment initiation
Demographic characteristic of participants who receive dupilumab for EoE: Race
时间窗: Baseline and up to 3 years after treatment initiation
Demographic characteristic of participants who receive dupilumab for EoE: Weight
时间窗: Baseline and up to 3 years after treatment initiation
EoE medication history of participant
时间窗: Previous 1 year and up to 3 years after treatment initiation
Prior dupilumab exposure history of participant
时间窗: Baseline and up to 3 years after treatment initiation
Demographic characteristic of participants who receive dupilumab for EoE: Height
时间窗: Baseline and up to 3 years after treatment initiation
Disease characteristics of participants who receive dupilumab for EoE: Dilation/impaction history
时间窗: Baseline and up to 3 years after treatment initiation
Non-EoE medication history of participant
时间窗: Previous 3 months and up to 3 years after treatment initiation
次要结局
未报告次要终点