CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry

CorEvitas

Status: Enrolling

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06238765

CorEvitas-AD-555

Details and patient eligibility

About

Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.

Full description

The objective of the registry is to create a cohort of adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators. Further, data collected will inform clinical decision making by patients and treating providers. This will be done through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.

This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 12 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• To be eligible to participate in this registry, an individual must meet all the following criteria:

  1. Has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified dermatology practitioner.

  2. Is 12 - 15 years of age at the time of enrollment.

  3. Meets one of the following conditions at the time of enrollment:

     1. Has started taking a new Enrollment Eligible Medication within 6 months prior to the Enrollment visit. A new medication is a medication that the subject has never taken before.

        OR

     2. Is prescribed a new Enrollment Eligible Medication at the Enrollment visit. A new medication is a medication that the subject has never taken before.

        Exclusion Criteria:

        An individual who meets any of the following criteria will be excluded from participation in the registry:

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  1. Is participating or planning to participate in a blinded clinical trial for an AD drug.