A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany

Официальное название

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

Обзор

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.

Подробное описание

The study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.

Вмешательства

• Препарат Dupilumab
  This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Первичные конечные точки

• Descriptive statistical analysis of medical history characteristics [Срок оценки: At baseline]
• Descriptive statistical analysis of socio-demographic characteristics [Срок оценки: At baseline]
• Descriptive statistical analysis of disease characteristics [Срок оценки: At baseline]

Вторичные конечные точки (12)

• Absolut change from baseline in endoscopic reference score (EREFS) [Срок оценки: After 3, 6 (optional), 12 and 24 months of dupilumab treatment]
• Proportion of patients with eosinophils per high power field (EOS/hpf) < 15 in esophageal biopsies [Срок оценки: After 3, 6 (optional), 12 and 24 months of dupilumab treatment]
• Change in clinical symptoms from baseline [Срок оценки: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment]
• Behavioral changes regarding food intake from baseline [Срок оценки: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment]
• Absolute change from baseline in Dysphagia Numerical Rating Scale (NRS) [Срок оценки: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment]
• Absolute change from baseline in Hospital Anxiety and Depression Scale (HADS) [Срок оценки: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment]
• Absolute change from baseline Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS v2.0) [Срок оценки: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment]
• Absolute change from baseline Pediatric Quality of Life Inventory (PEDS-QL) [Срок оценки: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment]
• Number of hospitalizations due to EoE [Срок оценки: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment]
• Number of sick leave days at work due to EoE [Срок оценки: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment]
• Reason(s) for initiation of dupilumab treatment [Срок оценки: At baseline]
• Descriptive statistical analysis of details on dupilumab treatment [Срок оценки: Throughout the study, for approximately 24 months after dupilumab treatment]

Критерии участия

Критерии включения

• Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy
• Patients for whom the treating physician has decided to initiate new treatment with dupilumab for EoE according to EU-SmPC independently from entry in study or for whom treatment with dupilumab for EoE according to EU-SmPC has been started within the last 7 days. The decision to initiate dupilumab treatment is made by the treating physician and the patient according to the patients' medical need and to the standard of best medical practice. This decision is made independently and before inclusion in this NIS.
• ≥ 12 years of age at baseline visit
• ≥ 40 kg bodyweight
• Voluntary study participation and signed written informed consent by patient and parent(s)/guardian(s), if applicable

Критерии исключения

• Patients who have a contraindication to dupilumab according to the current EU-SmPC.
• Patients who have been treated with dupilumab for more than 7 days
• Any acute or chronic condition that, in the treating physician's opinion, would limit the patients' ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
• Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study (parallel inclusion in another Sanofi-independent registry might be possible if the patient gives consent)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Investigational Site Number: 0000001 — Dachau

Идентификаторы

NCT: NCT06695897 · OBS18402 · U1111-1306-7545

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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