Atopic Dermatitis
Conditions
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.
Interventions
OTHERObservational Non-Interventional Registry
Observational Non-Interventional Registry
Sponsors
CorEvitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AD epidemiology, presentation, natural history, management, and outcomes | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Score: 0-4, with high score indicating widespread of atopic dermatitis |
| Physician reported: Nail changes due to atopic dermatitis (graduated VAS) | 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 |
| 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 | The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe. |
| Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated) | 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 |
| Patient reported: Patient global assessments of disease control and severity | every 6 months for 10 years | This determines the progression \& severity of the disease |
| 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 | — |
Countries
United States
Contacts
CONTACTAtopic Dermatitis Registry Team
Outcome results
None listed