CorEvitas, LLC
Waltham, Massachusetts, 02451, United States
NCT Number: NCT04504955
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Waltham, Massachusetts, 02451, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Has been diagnosed with AD by a dermatologist or qualified dermatology provider.
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.
Observational Non-Interventional Registry
Time frame: 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.
Time frame: at registry enrollment
Time frame: every 6 months for 10 years
Score: 0-4, with high score indicating widespread of atopic dermatitis
Time frame: 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
Time frame: every 6 months for 10 years
Time frame: 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.
Time frame: 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
Time frame: every 6 months for 10 years
This determines the progression & severity of the disease
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: 6 months for 10 years
CorEvitas
Network
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05735483
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Birmingham, Alabama, United States
View Trial DetailsNCT03976622
Alopecia, Alopecia Areata
Bordeaux, France
View Trial DetailsNCT06744569
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT06464133
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Philadelphia, Pennsylvania, United States
View Trial Details