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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Observational Non-Interventional Registry
  Observational Non-Interventional Registry

Первичные конечные точки

• AD epidemiology, presentation, natural history, management, and outcomes [Срок оценки: Through Study completion, an average of 10years]

Вторичные конечные точки (12)

• Percentage of patients with history of comorbidities [Срок оценки: at registry enrollment]
• Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) [Срок оценки: every 6 months for 10 years]
• Physician reported: Nail changes due to atopic dermatitis (graduated VAS) [Срок оценки: every 6 months for 10 years]
• Physician reported: Atopic dermatitis body surface area (BSA) [Срок оценки: every 6 months for 10 years]
• Physician reported: Eczema Area and Severity Index (EASI) (calculated) [Срок оценки: every 6 months for 10 years]
• Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated) [Срок оценки: every 6 months for 10 years]
• Patient reported: Patient global assessments of disease control and severity [Срок оценки: every 6 months for 10 years]
• Patient reported: Patient Oriented Eczema Measure (POEM) [Срок оценки: every 6 months for 10 years]
• Patient reported: Peak pruritus (itch) NRS [Срок оценки: every 6 months for 10 years]
• Patient reported: Skin pain NRS [Срок оценки: every 6 months for 10 years]
• Patient reported: Fatigue NRS [Срок оценки: every 6 months for 10 years]
• Patient reported: Dermatology Life Quality Index (DLQI) [Срок оценки: every 6 months for 10 years]

Критерии участия

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.

• At the time of registry enrollment OR
• Within 12 months prior to registry enrollment

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• CorEvitas, LLC — Waltham

Идентификаторы

NCT: NCT04504955 · CorEvitas-AD-550

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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