Dermatitis Atopic
Conditions
Brief summary
Primary Objectives: * To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable. * To evaluate the time-course of AD and selected atopic comorbidities. Secondary Objectives: * To characterize disease burden and unmet need. * To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching). * To document the real-world effectiveness and safety of treatments.
Detailed description
The study duration is 120 months.
Interventions
OTHERStandard of care
Treatment as per standard practice
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Patients with moderate to severe AD, according to the Investigator's assessment; * Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.
Exclusion criteria
* Concurrent participation in an interventional clinical trial which modifies patient care. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient demographics | Baseline (Month 0) |
| Medical history of selected atopic diseases and comorbidities | Baseline (Month 0) |
| Age at onset of atopic dermatitis (AD) | Baseline (Month 0) |
| Personal and family history of AD and selected atopic diseases | Baseline (Month 0) |
| All prior and current systemic AD treatment | Baseline (Month 0) |
| All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment) | Baseline (Month 0) |
| Presence/severity of AD and selected atopic comorbid conditions | Baseline to Month 120 |
| Therapy for selected atopic comorbid conditions | Baseline to Month 120 |
Secondary
| Measure | Time frame |
|---|---|
| Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL) | Baseline to Month 120 |
| Change in PRO: Dermatitis Family Impact (DFI) | Baseline to Month 120 |
| Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS | Baseline to Month 120 |
| Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit | Baseline to Month 120 |
| Change in PRO: Pediatric Asthma Questionnaire (PAQ) | Baseline to Month 120 |
| Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5) | Baseline to Month 120 |
| Adverse event (AE) reporting | Baseline to Month 120 |
| Change in PRO: Caregiver Global Assessment of Disease (CGAD) | Baseline to Month 120 |
| Change in PRO: Total Nasal Symptom Score (TNSS) | Baseline to Month 120 |
| Days missed from school for the patient and days missed from work for the primary caregiver due to AD | Baseline to Month 120 |
| Visits to healthcare professionals (HCPs) | Baseline to Month 120 |
| Treatments and prescribing patterns for pediatric AD | Baseline to Month 120 |
| Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI]) | Baseline to Month 120 |
| Changes in physician assessment of disease burden (Body Surface Area [BSA]) | Baseline to Month 120 |
| Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM) | Baseline to Month 120 |
Countries
Argentina, Australia, Brazil, Canada, China, Colombia, Denmark, France, Greece, Israel, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, South Korea, Spain, United States
Outcome results
None listed