Clinical trial NCT04504955: CorEvitas Atopic Dermatitis Registry: a Study of Post Approval Drug Safety and Effectiveness
Official title: CorEvitas Atopic Dermatitis Registry: a Study of Post Approval Drug Safety and Effectiveness
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Atopic Dermatitis
Lead sponsor: CorEvitas
Sponsor class: NETWORK
First posted: 2020-08-07
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: The objective of the CorEvitas 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.

Eligibility criteria: Inclusion Criteria Has been diagnosed with AD by a dermatologist or qualified dermatology provider.

2) 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.

3) 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.

1. At the time of registry enrollment OR
2. Within 12 months prior to registry enrollment

Exclusion Criteria:

1)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.

Primary outcomes:
measure: AD epidemiology, presentation, natural history, management, and outcomes
timeFrame: Through Study completion, an average of 10years
Secondary outcomes:
measure: Percentage of patients with history of comorbidities
timeFrame: at registry enrollment
measure: Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
timeFrame: every 6 months for 10 years
measure: Physician reported: Nail changes due to atopic dermatitis (graduated VAS)
timeFrame: every 6 months for 10 years
measure: Physician reported: Atopic dermatitis body surface area (BSA)
timeFrame: every 6 months for 10 years
measure: Physician reported: Eczema Area and Severity Index (EASI) (calculated)
timeFrame: every 6 months for 10 years
measure: Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)
timeFrame: every 6 months for 10 years
measure: Patient reported: Patient global assessments of disease control and severity
timeFrame: every 6 months for 10 years
measure: Patient reported: Patient Oriented Eczema Measure (POEM)
timeFrame: every 6 months for 10 years
measure: Patient reported: Peak pruritus (itch) NRS
timeFrame: every 6 months for 10 years
measure: Patient reported: Skin pain NRS
timeFrame: every 6 months for 10 years
measure: Patient reported: Fatigue NRS
timeFrame: every 6 months for 10 years
measure: Patient reported: Dermatology Life Quality Index (DLQI)
timeFrame: every 6 months for 10 years
measure: Patient reported: Work Productivity and Activity Impairment (WPAI)
timeFrame: every 6 months for 10 years
measure: Patient reported: Atopic dermatitis control tool (ADCT)
timeFrame: every 6 months for 10 years
measure: Patient reported: Itch triggers (PROMIS)
timeFrame: every 6 months for 10 years
measure: Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)
timeFrame: 6 months for 10 years
Other outcomes:
Locations:
city: Waltham
country: United States
facility: CorEvitas, LLC
state: Massachusetts
Study officials:
References: