Investigational Site Number: 0000001
Dachau, Bavaria, 85221, Germany
Location status: Recruiting
NCT Number: NCT06695897
This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with respect to their medical history, socio-demographic and disease characteristics, comorbidities (including type 2 inflammatory and atopic conditions), concomitant therapies and prior EoE treatments. Furthermore, this NIS aims to describe the long-term effectiveness of dupilumab for the treatment of EoE as assessed by the treating physician and reported by the patient, and its effect on health-related quality of life (HRQoL) during an individual observational period of two years. In addition, data on real-world use patterns and long-term safety data of dupilumab treatment for EoE will be collected.
Interested in participating?
Request Info12 year and older
All sexes
Observational
Dachau, Bavaria, 85221, Germany
Location status: Recruiting
The study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Time frame: At baseline
Time frame: At baseline
Time frame: At baseline
Time frame: After 3, 6 (optional), 12 and 24 months of dupilumab treatment
Absolut change from baseline in EREFS (including inflammatory and fibrostenotic subscore)
Time frame: After 3, 6 (optional), 12 and 24 months of dupilumab treatment
Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Change in clinical symptoms (as assessed in clinical practice) from baseline
Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Behavioral changes regarding food intake (as reported by the patient)
Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Scale from 0 (no trouble to swallow) - 10 (maximum trouble to swallow)
Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Time frame: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment
Time frame: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment
Time frame: At baseline
Time frame: Throughout the study, for approximately 24 months after dupilumab treatment
Descriptive analysis: form of administration, location of administration
Time frame: Throughout the study, for approximately 24 months after initiation of dupilumab treatment
Quantity of treatment emergent adverse events, quantity of TEAE that lead to ending of therapy, collection of type of TEAE
Contact information is provided by the study sponsor or research team.
Sanofi
Industry
Prospective, Non-interventional Observational Study to Characterize Dupilumab in the Long-term Management of Eosinophilic Esophagitis, Safety and Patient Reported Outcomes (Quality of Life) in Clinical Routine
Acronym: ProMEAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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