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Clinical Trials/NCT03687359
NCT03687359
Active, Not Recruiting
N/A

Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

Sanofi180 sites in 2 countries1,860 target enrollmentAugust 15, 2019
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ConditionsDermatitis Atopic

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dermatitis Atopic
Sponsor
Sanofi
Enrollment
1860
Locations
180
Primary Endpoint
Age at onset of atopic dermatitis (AD)
Status
Active, Not Recruiting
Last Updated
8 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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 60 months.

Registry
clinicaltrials.gov
Start Date
August 15, 2019
End Date
July 23, 2035
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sanofi
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Age at onset of atopic dermatitis (AD)

Time Frame: Baseline (Month 0)

Patient demographics

Time Frame: Baseline (Month 0)

Medical history of selected atopic diseases and comorbidities

Time Frame: Baseline (Month 0)

Personal and family history of AD and selected atopic diseases

Time Frame: Baseline (Month 0)

All prior and current systemic AD treatment

Time Frame: Baseline (Month 0)

All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)

Time Frame: Baseline (Month 0)

Presence/severity of AD and selected atopic comorbid conditions

Time Frame: Baseline to Month 120

Therapy for selected atopic comorbid conditions

Time Frame: Baseline to Month 120

Secondary Outcomes

  • 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)
  • 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: Caregiver Global Assessment of Disease (CGAD)(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: Total Nasal Symptom Score (TNSS)(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)

Study Sites (180)

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