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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04504955
• Other study ID #: Corrona-AD-550
• Status: Enrolling by invitation
• Start date: July 14, 2020
• Est. completion date: December 2100

Study information

• Verified date: March 2023
• Source: CorEvitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: December 2100
• Est. primary completion date: December 2100
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Observational Non-Interventional Registry
Observational Non-Interventional Registry

Locations

Country	Name	City	State
United States	Corrona, LLC	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CorEvitas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients with history of comorbidities		at registry enrollment
Secondary	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
Secondary	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
Secondary	Physician reported: Atopic dermatitis body surface area (BSA)		every 6 months for 10 years
Secondary	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
Secondary	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
Secondary	Patient reported: Patient global assessments of disease control and severity	This determines the progression & severity of the disease	every 6 months for 10 years
Secondary	Patient reported: Patient Oriented Eczema Measure (POEM)		every 6 months for 10 years
Secondary	Patient reported: Peak pruritus (itch) NRS		every 6 months for 10 years
Secondary	Patient reported: Skin pain NRS		every 6 months for 10 years
Secondary	Patient reported: Fatigue NRS		every 6 months for 10 years
Secondary	Patient reported: Dermatology Life Quality Index (DLQI)		every 6 months for 10 years
Secondary	Patient reported: Work Productivity and Activity Impairment (WPAI)		every 6 months for 10 years
Secondary	Patient reported: Atopic dermatitis control tool (ADCT)		every 6 months for 10 years
Secondary	Patient reported: Itch triggers (PROMIS)		every 6 months for 10 years
Secondary	Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)		6 months for 10 years