Clinical trial NCT06238765: CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
Official title: CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: CorEvitas
Sponsor class: NETWORK
First posted: 2024-02-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects can enroll as early as age 12 and will be followed until the age of 18; therefore, the maximum duration a subject can be enrolled is \< 6 years.

Brief 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.

Detailed 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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: AD epidemiology, presentation, natural history, management, and outcomes
timeFrame: Through Study completion until the subject is 18 years
Secondary outcomes:
measure: Percentage of patients with history of comorbidities
timeFrame: Time Frame: at registry enrollment
measure: Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD
timeFrame: every 6 months until the subject is 18 years
measure: Physician reported: Nail changes due to atopic dermatitis (graduated VAS)
timeFrame: every 6 months until the subject is 18 years
measure: Atopic dermatitis body surface area (BSA)
timeFrame: every 6 months until the subject is 18 years
measure: Eczema Area and Severity Index (EASI) (calculated)
timeFrame: every 6 months until the subject is 18 years
measure: Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)
timeFrame: every 6 months until the subject is 18 years
measure: Patient reported : Patient global assessments of disease control and severity
timeFrame: every 6 months until the subject is 18 years
measure: Physician reported : Pubertal Progression: Tanner Staging Assessment
timeFrame: Every six Months until a subject is 18 years or the subjects reaches stage 5 of the ranner stangins assessment
measure: Patient reported: Patient Oriented Eczema Measure (POEM)
timeFrame: every 6 months until the subject is 18 years
measure: Patient reported: Peak pruritus (itch) NRS
timeFrame: every 6 months until the subject is 18 years
measure: Patient reported: Skin pain NRS
timeFrame: every 6 months until the subject is 18 years
measure: Patient reported: Fatigue NRS
timeFrame: every 6 months until the subject is 18 years
measure: Patient reported: Children's Dermatology Life Quality Index (CDLQI)
timeFrame: every 6 months until the subject is 18 years
measure: Patient reported: Patient Health Questionnaire (PHQ-4)
timeFrame: every 6 months until the subject is 18 years
measure: Patient reported: Atopic dermatitis control tool (ADCT)
timeFrame: every 6 months until the subject is 18 years
measure: Patient reported: Asthma Control test
timeFrame: every 6 months until the subject is 18 years
measure: Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)
timeFrame: 6 months until the subject is 18 years
Other outcomes:
Locations:
city: Waltham
country: United States
facility: CorEvitas, LLC
state: Massachusetts
Study officials:
References: