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

Sponsored by CorEvitas

About this trial

Last updated 7 months ago

Study ID

CorEvitas-AD-550

Status

Enrolling by invitation

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 5 years ago

What is this trial about?

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

What are the Participation Requirements?

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.

Locations

Location

Status