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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1306-7545 | Registry Identifier | ICTRP |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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.
The study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab arm | Patients who receive dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive statistical analysis of medical history characteristics | At baseline | |
| Descriptive statistical analysis of socio-demographic characteristics | At baseline | |
| Descriptive statistical analysis of disease characteristics | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Absolut change from baseline in endoscopic reference score (EREFS) | Absolut change from baseline in EREFS (including inflammatory and fibrostenotic subscore) | 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 |
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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.
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Patients suffering from EoE, ≥ 12 years of age with at least 40 kg bodyweight who are planned to be initiated with dupilumab for the treatment of EoE according to the prescribing information, i.e., the current Summary of Product Characteristics approved in the European Union (EU-SmPC).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 0000001 | Recruiting | Dachau | Bavaria | 85221 | Germany |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| After 3, 6 (optional), 12 and 24 months of dupilumab treatment |
| Change in clinical symptoms from baseline | Change in clinical symptoms (as assessed in clinical practice) from baseline | From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment |
| Behavioral changes regarding food intake from baseline | Behavioral changes regarding food intake (as reported by the patient) | 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) | Scale from 0 (no trouble to swallow) - 10 (maximum trouble to swallow) | After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment |
| Absolute change from baseline in Hospital Anxiety and Depression Scale (HADS) | 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) | After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment |
| Absolute change from baseline Pediatric Quality of Life Inventory (PEDS-QL) | After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment |
| Number of hospitalizations due to EoE | 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 | During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment |
| Reason(s) for initiation of dupilumab treatment | At baseline |
| Descriptive statistical analysis of details on dupilumab treatment | Descriptive analysis: form of administration, location of administration | Throughout the study, for approximately 24 months after dupilumab treatment |
| Analysis of treatment emergent adverse events (TEAEs) | Quantity of treatment emergent adverse events, quantity of TEAE that lead to ending of therapy, collection of type of TEAE | Throughout the study, for approximately 24 months after initiation of dupilumab treatment |
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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