This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment
Non-interventional Study of Systemic Treatments in Adolescents and Adults with Atopic Dermatitis
Study Overview
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Atopic Dermatitis
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Age: 12 years or above
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Gender: All
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.
This study investigates atopic dermatitis (AD) in adolescents and adults. The purpose is to understand the unmet needs of patients with AD and evaluate the safety and effectiveness of systemic treatments in real-world settings. The study will also examine factors like age, skin color, triggers for AD flares, and other health conditions that might affect treatment outcomes.
Participants will be observed as they start or change their systemic treatment for AD, which includes medications that affect the entire body. This non-interventional study means that researchers will not change the participants' treatments but will collect data on their experiences and outcomes during their usual care.
- Who can participate: Individuals aged 12 years and older with a confirmed diagnosis of atopic dermatitis are eligible. They must be starting or switching to a systemic treatment and provide informed consent for long-term follow-up.
- Study details: Participants will be involved in a non-interventional study where their usual care will be observed and documented. They will not receive any investigational drug as part of this study.
- Study timelines: The study will last 5 years.