Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD)

Sanofi

Status: Active, not recruiting

Conditions: Dermatitis Atopic

Treatments: Other: Standard of care

Study type: Observational

Funder types: Industry

Identifiers

NCT03687359

OBS15333

U1111-1211-9437 (Other Identifier)

Details and patient eligibility

About

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.

Full description

The study duration is 120 months.

Enrollment: 1,860 patients

Sex: All

Ages: Under 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,860 participants in 1 patient group

Participants with atopic dermatitis (AD)

Description:

Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enroll in the study.

Treatment:

Other: Standard of care