CorEvitas Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness

NCT04504955 | Enrolling By Invitation

• 1 other identifier: CorEvitas-AD-550
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for patients with atopic dermatitis under the care of a licensed dermatologist or qualified physician extender. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices. Condition or disease : Atopic Dermatitis

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• AD epidemiology, presentation, natural history, management, and outcomes

  The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.

  Through Study completion, an average of 10years

Secondary Outcomes (16)

• Percentage of patients with history of comorbidities

  at registry enrollment

• Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)

  every 6 months for 10 years

• Physician reported: Nail changes due to atopic dermatitis (graduated VAS)

  every 6 months for 10 years

• Physician reported: Atopic dermatitis body surface area (BSA)

  every 6 months for 10 years

• Physician reported: Eczema Area and Severity Index (EASI) (calculated)

  every 6 months for 10 years

Study Arms (1)

Atopic Dermatitis

Pts presenting to enrolling sites across in North America and select European countries are invited to enroll if eligible

Other: Observational Non-Interventional Registry

Interventions

Observational Non-Interventional Registry OTHER

Observational Non-Interventional Registry

Atopic Dermatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are enrolled in the Atopic Dermatitis Registry during regularly scheduled office visits clinical encounters. Selected dermatologists are invited to participate as investigators in the Registry.

You may qualify if:

• \) Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted.
• \) Willing and able to provide consent for participation in the registry. 4) Willing and able to provide Personal Information (full legal name, sex, date of birth, home address zip/postal code, and email address OR phone number at a minimum) if required based on registry location and applicable laws and regulations. 5) Has been prescribed a new Enrollment Eligible Medication. A new therapy is a medication that the subject has never taken before.
• At the time of registry enrollment OR
• Within 12 months prior to registry enrollment

You may not qualify if:

• )Is participating or planning to participate in a blinded clinical trial for an AD drug.
• Follow-Up Criteria
• Registry Follow-Up data collection should be done at the time of routine clinical encounters approximately every 6 months. Routine or standard of care clinical encounters may occur in between two registry visits, but the data collected in the Follow-Up forms should cover the time period since the last registry visit.
• For planning purposes, each Follow-Up visit is anchored to the date of the last eligible registry visit. A Follow-Up visit is eligible for payment if 150 days have passed since the last visit submission. A Follow-Up visit is not eligible for payment if conducted less than 150 days since the last registry visits except when the EARLY Follow-Up visit Criteria are satisfied.
• EARLY Follow-Up Criteria
• A registry Follow-Up visit should be conducted whenever a patient is prescribed or receiving the first dose of a new Eligible Medication even if less than 150 days have passed since the last registry visit. When the EARLY Follow-Up criteria are met, the next anticipated registry visit is calculated from the date of the Early Follow-Up visit.

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen collection is optional.It will consist of biospecimens (peripheral blood serum, plasma, DNA, and RNA)) for biobanking, biomarker, and other related analysis linked to registry (patient and provider reported) data and imaging

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 7, 2020
• Study Start: July 14, 2020
• Primary Completion (Estimated): December 1, 2100
• Study Completion (Estimated): December 1, 2100
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)