This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment (ARMADA-AD)

Sanofi

Status: Enrolling

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT07290803

U1111-1311-1824 (Registry Identifier)

OBS18388

Details and patient eligibility

About

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.

The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged more than or equal to (≥) 12 years at the time of consent.
• Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.
• Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)
• Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.

Exclusion criteria

• Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.
• Insufficient understanding of the study by the patient and/or parent/guardian.

Trial design

1,000 participants in 1 patient group

Atopic Dermatitis

Description:

This study plans to collect information on adolescent and adult patients with atopic dermatitis who initiate or switch any systemic treatment (eg, biologics, oral Janus kinase \[JAK\] inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) for AD according to the country-specific prescribing information. During the study, investigators will prescribe medical products for treatment of AD per standard of care (SoC) and per medical judgment.