Prospective, Observational, Longitudinal Study in Paediatric Patients With AD, Treated With Dupilumab in Spain
Overview
- Phase
- Not Applicable
- Intervention
- Dupilumab
- Conditions
- Atopic Dermatitis
- Sponsor
- Sanofi
- Enrollment
- 143
- Locations
- 15
- Primary Endpoint
- Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged 6 months to 11 years old at baseline.
- •Patients with severe Atopic dermatitis (AD) according to the investigator's assessment.
- •Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records).
- •Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age.
Exclusion Criteria
- •Patients who are participating in an interventional clinical trial that modifies patient care.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Arms & Interventions
Dupilumab
The information will be collected during consultation as part of the patient's usual follow-up.
Intervention: Dupilumab
Outcomes
Primary Outcomes
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age
Time Frame: At baseline
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender
Time Frame: At baseline
Medical history of atopic comorbidities
Time Frame: At baseline
Selected atopic comorbidities over time will be reported.
Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI)
Time Frame: At baseline
Medical history characteristics of pediatric patients initiating treatment with dupilumab for Severe AD
Time Frame: At baseline
Including course of AD, recent AD treatment history, family history.
Medical history of non-atopic diseases
Time Frame: At baseline
Secondary Outcomes
- Description of real-world treatment patterns (other treatments): Other type of treatment(From baseline up to 24 months)
- Description of real-world treatment patterns (other treatments): Duration of treatment(From baseline up to 24 months)
- Participant-caregiver assessment: Change from baseline in the Infant's Dermatology Life Quality Index score(From baseline up to 24 months)
- Description of real-world treatment patterns (other treatments): Name of treatment(From baseline up to 24 months)
- Description of real-world treatment patterns (other treatments): Reason for discontinuation (if applicable)(From baseline up to 24 months)
- Description of real-world treatment patterns: Dupilumab dosage(From baseline up to 24 months)
- Description of real-world treatment patterns: Dupilumab frequency of administration(From baseline up to 24 months)
- Description of real-world treatment patterns: Dupilumab reason for discontinuation(From baseline up to 24 months)
- Participant-caregiver assessment: Change from baseline in the Children's Dermatology Life Quality Index score(From baseline up to 24 months)
- Participant-caregiver assessment: Change from baseline in the Dermatitis Family Impact (DFI) questionnaire(From baseline up to 24 months)
- Participant-caregiver assessment: Change from baseline in the patient's Worst Itch Numerical Rating Scale (WI-NRS)(From baseline up to 24 months)
- Caregiver assessment: Change from baseline in the patient's Worst Itch Scale Numerical Rating Scale (WSI-NRS)(From baseline up to 24 months)
- Physician assessment: Percent change from beseline in the Body Surface Area (BSA) (%) affected by AD(From baseline up to 24 months)
- Physician assessment: Change in Proportion of patients with Validated Investigator's Global Assessment (IGA)(From baseline up to 24 months)
- Physician assessment: Change from baseline in Biomarkers(From baseline up to 24 months)
- Number of Adverse Events (AE) / Serious Adverse Events (SAE) / Adverse Event of Special Interest (AESI)(From date of signed ICF, up to 24 months)
- Physician assessment: Change from baseline in the eczema severity using the Eczema Area and Severity Index (EASI)(From baseline up to 24 months)
- Health Care Resource Utilization (HCRU) Questionnaire(From baseline up to 24 months)