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

• ClinicalTrials.gov Identifier: NCT04504955
• Recruitment Status: Enrolling by invitation
• First Posted: August 7, 2020
• Last Update Posted: March 8, 2023
• Sponsor: CorEvitas
• Information provided by (Responsible Party): CorEvitas

Study Description

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

Condition or disease	Intervention/treatment
Atopic Dermatitis	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 Design

• Study Type: Observational
• Estimated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Corrona Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness
• Actual Study Start Date: July 14, 2020
• Estimated Primary Completion Date: December 2100
• Estimated Study Completion Date: December 2100

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. AD epidemiology, presentation, natural history, management, and outcomes [ Time Frame: Through Study completion, an average of 10years ]
   The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.

Secondary Outcome Measures :

1. Percentage of patients with history of comorbidities [ Time Frame: at registry enrollment ]
2. Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) [ Time Frame: every 6 months for 10 years ]
   Score: 0-4, with high score indicating widespread of atopic dermatitis
3. Physician reported: Nail changes due to atopic dermatitis (graduated VAS) [ Time Frame: every 6 months for 10 years ]
   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
4. Physician reported: Atopic dermatitis body surface area (BSA) [ Time Frame: every 6 months for 10 years ]
5. Physician reported: Eczema Area and Severity Index (EASI) (calculated) [ Time Frame: every 6 months for 10 years ]
   The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe.
6. Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated) [ Time Frame: every 6 months for 10 years ]
   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
7. Patient reported: Patient global assessments of disease control and severity [ Time Frame: every 6 months for 10 years ]
   This determines the progression & severity of the disease
8. Patient reported: Patient Oriented Eczema Measure (POEM) [ Time Frame: every 6 months for 10 years ]
9. Patient reported: Peak pruritus (itch) NRS [ Time Frame: every 6 months for 10 years ]
10. Patient reported: Skin pain NRS [ Time Frame: every 6 months for 10 years ]
11. Patient reported: Fatigue NRS [ Time Frame: every 6 months for 10 years ]
12. Patient reported: Dermatology Life Quality Index (DLQI) [ Time Frame: every 6 months for 10 years ]
13. Patient reported: Work Productivity and Activity Impairment (WPAI) [ Time Frame: every 6 months for 10 years ]
14. Patient reported: Atopic dermatitis control tool (ADCT) [ Time Frame: every 6 months for 10 years ]
15. Patient reported: Itch triggers (PROMIS) [ Time Frame: every 6 months for 10 years ]
16. Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD) [ Time Frame: 6 months for 10 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

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.

Contacts and Locations

Locations

United States, Massachusetts

Corrona, LLC

Waltham, Massachusetts, United States, 02451

Sponsors and Collaborators

CorEvitas

More Information

• Responsible Party: CorEvitas
• ClinicalTrials.gov Identifier: NCT04504955
• Other Study ID Numbers: Corrona-AD-550
• First Posted: August 7, 2020
• Last Update Posted: March 8, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases