Eosinophilic Esophagitis (EoE)
Conditions
Brief summary
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
Interventions
DRUGdupilumab
No investigational agents will be provided. Dupilumab will be prescribed as per usual clinical practice and will not be provided by the sponsor.
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Initiating treatment with DUPIXENT® for EoE according to the USPI 2. Participants aged ≥12 years and caregivers or legal guardians of participants aged \<12 years must be able to understand and complete registry-related questionnaires Key
Exclusion criteria
1. Patients who have a contraindication to DUPIXENT® according to the USPI 2. Treatment with DUPIXENT® within the 6 months prior to the screening assessment 3. 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demographic characteristic of participants who receive dupilumab for EoE: Age | Baseline and up to 3 years after treatment initiation |
| Demographic characteristic of participants who receive dupilumab for EoE: Race | Baseline and up to 3 years after treatment initiation |
| Demographic characteristic of participants who receive dupilumab for EoE: Weight | Baseline and up to 3 years after treatment initiation |
| Demographic characteristic of participants who receive dupilumab for EoE: Height | Baseline and up to 3 years after treatment initiation |
| Disease characteristics of participants who receive dupilumab for EoE: Esophagogastroduodenoscopy (EGD) | Baseline and up to 3 years after treatment initiation |
| Disease characteristics of participants who receive dupilumab for EoE: Dilation/impaction history | Baseline and up to 3 years after treatment initiation |
| Disease characteristics of participants who receive dupilumab for EoE: Dietary interventions | Baseline and up to 3 years after treatment initiation |
| Disease characteristics of participants who receive dupilumab for EoE: Medical history | Baseline and up to 3 years after treatment initiation |
| EoE medication history of participant | Previous 1 year and up to 3 years after treatment initiation |
| Non-EoE medication history of participant | Previous 3 months and up to 3 years after treatment initiation |
| Prior dupilumab exposure history of participant | Baseline and up to 3 years after treatment initiation |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed