CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry

Atopic Dermatitis Clinical Trial

Official title:

CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06238765
• Other study ID #: CorEvitas-AD-555
• Status: Enrolling by invitation
• Start date: December 2, 2023
• Est. completion date: December 31, 2099

Study information

• Verified date: February 2024
• Source: CorEvitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.

Description:

The objective of the registry is to create a cohort of adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators. Further, data collected will inform clinical decision making by patients and treating providers. This will be done through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.

This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: December 31, 2099
• Est. primary completion date: December 31, 2099
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

Inclusion Criteria:

• To be eligible to participate in this registry, an individual must meet all the following criteria:

1. Has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified dermatology practitioner.

2. Is 12 - 15 years of age at the time of enrollment.

3. Meets one of the following conditions at the time of enrollment:

1. Has started taking a new Enrollment Eligible Medication within 6 months prior to the Enrollment visit. A new medication is a medication that the subject has never taken before.

OR

2. Is prescribed a new Enrollment Eligible Medication at the Enrollment visit. A new medication is a medication that the subject has never taken before.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in the registry:

1. Is participating or planning to participate in a blinded clinical trial for an AD drug.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
United States	CorEvitas, LLC	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CorEvitas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AD epidemiology, presentation, natural history, management, and outcomes	The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.	Through Study completion until the subject is 18 years
Secondary	Percentage of patients with history of comorbidities		Time Frame: at registry enrollment
Secondary	Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD	Score: 0-4, with high score indicating widespread of atopic dermatitis	every 6 months until the subject is 18 years
Secondary	Physician reported: Nail changes due to atopic dermatitis (graduated VAS)	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	every 6 months until the subject is 18 years
Secondary	Atopic dermatitis body surface area (BSA)		every 6 months until the subject is 18 years
Secondary	Eczema Area and Severity Index (EASI) (calculated)	The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe.	every 6 months until the subject is 18 years
Secondary	Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)	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	every 6 months until the subject is 18 years
Secondary	Patient reported : Patient global assessments of disease control and severity	This determines the progression & severity of the disease	every 6 months until the subject is 18 years
Secondary	Physician reported : Pubertal Progression: Tanner Staging Assessment		Every six Months until a subject is 18 years or the subjects reaches stage 5 of the ranner stangins assessment
Secondary	Patient reported: Patient Oriented Eczema Measure (POEM)		every 6 months until the subject is 18 years
Secondary	Patient reported: Peak pruritus (itch) NRS		every 6 months until the subject is 18 years
Secondary	Patient reported: Skin pain NRS		every 6 months until the subject is 18 years
Secondary	Patient reported: Fatigue NRS		every 6 months until the subject is 18 years
Secondary	Patient reported: Children's Dermatology Life Quality Index (CDLQI)		every 6 months until the subject is 18 years
Secondary	Patient reported: Patient Health Questionnaire (PHQ-4)		every 6 months until the subject is 18 years
Secondary	Patient reported: Atopic dermatitis control tool (ADCT)		every 6 months until the subject is 18 years
Secondary	Patient reported: Asthma Control test		every 6 months until the subject is 18 years
Secondary	Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)		6 months until the subject is 18 years