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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Observational Non-Interventional Registry

Detailed Description

The objective of the Corrona Atopic Dermatitis (AD) Registry is to create a national cohort of patients with atopic dermatitis. Data collected will be used to extensively evaluate the effectiveness and safety of medications used to treat atopic dermatitis. This will be done through the standardized collection of patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), and the prevalence and incidence of comorbidities and adverse events, medication utilization patterns, and patient productivity measures.

The design is a prospective, non-interventional registry for patients with AD under the care of a dermatologist or qualified physician extender. Longitudinal data are collected from both patients and their treating dermatology providers during routine clinical encounters using a structured and standardized data collection method. The scope of data collection includes but is not limited to patient demographics, disease phenotype, duration, medical history (including all prior and current treatments for AD), smoking status, alcohol use, disease activity and severity, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes.

After the enrollment visit, AD patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers approximately every six-months.

Adverse events may be volunteered spontaneously by the subject or be discovered as a result of general questioning by the Investigator. During all Corrona related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Corrona, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Patient has been diagnosed with atopic dermatitis by a dermatologist or a qualified dermatology practitioner
2. Patient is at least 18 years of age or older
3. Patient is willing to provide Personal Information

4. Patient meets ONE (1) of the following conditions at the time of enrollment:

   1. Has started taking a new Eligible Medication within the 12 months prior to the Enrollment visit.
   2. Is prescribed a new Eligible Medication at the Enrollment visit.
   3. Is NOT being treated with an Eligible Medication at the time of enrollment but has an Eczema Area Severity Index score ≥ 12 AND a Validated Investigator Global Assessment scale for Atopic Dermatitis score ≥ 3.

Exclusion Criteria:

1)Patient must not be participating in or planning to participate in a double-blind randomized trial for a systemic atopic dermatitis medication. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Observational Non-Interventional Registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with history of comorbidities		at registry enrollment
Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)	Score: 0-4, with high score indicating widespread of atopic dermatitis	every 6 months for 10 years
Physician reported: Nail changes due to atopic dermatitis (graduated VAS)	Scale - 0 (Clear/Normal) to 100 (Severe Abnormalities). Lower numbers are for mild abnormalities in a few nails, higher numbers are for more severe changes in many nails	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)	The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe.	every 6 months for 10 years
Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)	The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe. For the Overall Score [SCORAD], select a lesion that that is representative of the body and score using the same severity scale	every 6 months for 10 years
Patient reported: Patient global assessments of disease control and severity	This determines the progression & severity of the disease	every 6 months for 10 years
Patient reported: Patient Oriented Eczema Measure (POEM)		every 6 months for 10 years
Patient reported: Peak pruritus (itch) NRS		every 6 months for 10 years
Patient reported: Skin pain NRS		every 6 months for 10 years
Patient reported: Fatigue NRS		every 6 months for 10 years
Patient reported: Dermatology Life Quality Index (DLQI)		every 6 months for 10 years
Patient reported: Work Productivity and Activity Impairment (WPAI)		every 6 months for 10 years
Patient reported: Atopic dermatitis control tool (ADCT)		every 6 months for 10 years
Patient reported: Itch triggers (PROMIS)		every 6 months for 10 years
Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)		6 months for 10 years

Collaborators and Investigators

• Sponsor: CorEvitas

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Anticipated): December 1, 2100
• Study Completion (Anticipated): December 1, 2100

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: Corrona-AD-550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No