<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04504955</url>
  </required_header>
  <id_info>
    <org_study_id>Corrona-AD-550</org_study_id>
    <nct_id>NCT04504955</nct_id>
  </id_info>
  <brief_title>Corrona Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness</brief_title>
  <official_title>Corrona Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CorEvitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CorEvitas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, non-interventional research registry is designed to study the comparative&#xD;
      effectiveness and comparative safety of approved treatments for patients with atopic&#xD;
      dermatitis under the care of a licensed dermatologist or qualified physician extender.&#xD;
      Secondary objectives include analyzing the epidemiology and natural history of the disease,&#xD;
      its comorbidities, and current treatment practices.&#xD;
&#xD;
      Condition or disease :&#xD;
&#xD;
      Atopic Dermatitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the Corrona Atopic Dermatitis (AD) Registry is to create a national cohort&#xD;
      of patients with atopic dermatitis. Data collected will be used to extensively evaluate the&#xD;
      effectiveness and safety of medications used to treat atopic dermatitis. This will be done&#xD;
      through the standardized collection of patient-reported outcomes (PRO) and clinician-reported&#xD;
      outcomes (ClinRO), and the prevalence and incidence of comorbidities and adverse events,&#xD;
      medication utilization patterns, and patient productivity measures.&#xD;
&#xD;
      The design is a prospective, non-interventional registry for patients with AD under the care&#xD;
      of a dermatologist or qualified physician extender. Longitudinal data are collected from both&#xD;
      patients and their treating dermatology providers during routine clinical encounters using a&#xD;
      structured and standardized data collection method. The scope of data collection includes but&#xD;
      is not limited to patient demographics, disease phenotype, duration, medical history&#xD;
      (including all prior and current treatments for AD), smoking status, alcohol use, disease&#xD;
      activity and severity, as well as other clinician- and patient-reported outcomes,&#xD;
      comorbidities and adverse events, infections, hospitalizations, and other targeted safety&#xD;
      outcomes.&#xD;
&#xD;
      After the enrollment visit, AD patients and physicians will complete the follow-up&#xD;
      questionnaires during regularly scheduled clinical encounters. The goal is to collect data&#xD;
      from patients and providers approximately every six-months.&#xD;
&#xD;
      Adverse events may be volunteered spontaneously by the subject or be discovered as a result&#xD;
      of general questioning by the Investigator. During all Corrona related visits with the&#xD;
      Investigator, subjects will be questioned regarding the occurrence of adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">December 2100</completion_date>
  <primary_completion_date type="Anticipated">December 2100</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>AD epidemiology, presentation, natural history, management, and outcomes</measure>
    <time_frame>Through Study completion, an average of 10years</time_frame>
    <description>The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with history of comorbidities</measure>
    <time_frame>at registry enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
    <description>Score: 0-4, with high score indicating widespread of atopic dermatitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician reported: Nail changes due to atopic dermatitis (graduated VAS)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician reported: Atopic dermatitis body surface area (BSA)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician reported: Eczema Area and Severity Index (EASI) (calculated)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
    <description>The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Patient global assessments of disease control and severity</measure>
    <time_frame>every 6 months for 10 years</time_frame>
    <description>This determines the progression &amp; severity of the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Patient Oriented Eczema Measure (POEM)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Peak pruritus (itch) NRS</measure>
    <time_frame>every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Skin pain NRS</measure>
    <time_frame>every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Fatigue NRS</measure>
    <time_frame>every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Work Productivity and Activity Impairment (WPAI)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Atopic dermatitis control tool (ADCT)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Itch triggers (PROMIS)</measure>
    <time_frame>every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)</measure>
    <time_frame>6 months for 10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Atopic Dermatitis</arm_group_label>
    <description>Pts presenting to enrolling sites across in North America and select European countries are invited to enroll if eligible</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational Non-Interventional Registry</intervention_name>
    <description>Observational Non-Interventional Registry</description>
    <arm_group_label>Atopic Dermatitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients are enrolled in the Atopic Dermatitis Registry during regularly scheduled office&#xD;
        visits clinical encounters. Selected dermatologists are invited to participate as&#xD;
        investigators in the Registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient has been diagnosed with atopic dermatitis by a dermatologist or a qualified&#xD;
             dermatology practitioner&#xD;
&#xD;
          2. Patient is at least 18 years of age or older&#xD;
&#xD;
          3. Patient is willing to provide Personal Information&#xD;
&#xD;
          4. Patient meets ONE (1) of the following conditions at the time of enrollment:&#xD;
&#xD;
               1. Has started taking a new Eligible Medication within the 12 months prior to the&#xD;
                  Enrollment visit.&#xD;
&#xD;
               2. Is prescribed a new Eligible Medication at the Enrollment visit.&#xD;
&#xD;
               3. Is NOT being treated with an Eligible Medication at the time of enrollment but&#xD;
                  has an Eczema Area Severity Index score ≥ 12 AND a Validated Investigator Global&#xD;
                  Assessment scale for Atopic Dermatitis score ≥ 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1)Patient must not be participating in or planning to participate in a double-blind&#xD;
        randomized trial for a systemic atopic dermatitis medication. Note: Concurrent&#xD;
        participation in another observational registry or open-label Phase 3b/4 trial is allowed.&#xD;
&#xD;
        Follow-Up Criteria&#xD;
&#xD;
        Registry Follow-Up data collection should be done at the time of routine clinical&#xD;
        encounters approximately every 6 months. Routine or standard of care clinical encounters&#xD;
        may occur in between two registry visits, but the data collected in the Follow-Up forms&#xD;
        should cover the time period since the last registry visit.&#xD;
&#xD;
        For planning purposes, each Follow-Up visit is anchored to the date of the last eligible&#xD;
        registry visit. A Follow-Up visit is eligible for payment if 150 days have passed since the&#xD;
        last visit submission. A Follow-Up visit is not eligible for payment if conducted less than&#xD;
        150 days since the last registry visits except when the EARLY Follow-Up visit Criteria are&#xD;
        satisfied.&#xD;
&#xD;
        EARLY Follow-Up Criteria&#xD;
&#xD;
        A registry Follow-Up visit should be conducted whenever a patient is prescribed or&#xD;
        receiving the first dose of a new Eligible Medication even if less than 150 days have&#xD;
        passed since the last registry visit. When the EARLY Follow-Up criteria are met, the next&#xD;
        anticipated registry visit is calculated from the date of the Early Follow-Up visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Corrona, LLC</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04504955
org study id: Corrona-AD-550
nct id: NCT04504955
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
The objective of the Corrona 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.

      The design is a prospective, non-interventional registry for patients with AD under the care
      of a dermatologist or qualified physician extender. Longitudinal data are collected from both
      patients and their treating dermatology providers during routine clinical encounters using a
      structured and standardized data collection method. The scope of data collection includes but
      is not limited to patient demographics, disease phenotype, duration, medical history
      (including all prior and current treatments for AD), smoking status, alcohol use, disease
      activity and severity, as well as other clinician- and patient-reported outcomes,
      comorbidities and adverse events, infections, hospitalizations, and other targeted safety
      outcomes.

      After the enrollment visit, AD patients and physicians will complete the follow-up
      questionnaires during regularly scheduled clinical encounters. The goal is to collect data
      from patients and providers approximately every six-months.

      Adverse events may be volunteered spontaneously by the subject or be discovered as a result
      of general questioning by the Investigator. During all Corrona related visits with the
      Investigator, subjects will be questioned regarding the occurrence of adverse events.
observational model: Cohort
time perspective: Prospective
measure: AD epidemiology, presentation, natural history, management, and outcomes
time frame: Through Study completion, an average of 10years
description: The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.
measure: Percentage of patients with history of comorbidities
time frame: at registry enrollment
measure: Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
time frame: every 6 months for 10 years
description: Score: 0-4, with high score indicating widespread of atopic dermatitis
measure: Physician reported: Nail changes due to atopic dermatitis (graduated VAS)
time frame: every 6 months for 10 years
description: 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
measure: Physician reported: Atopic dermatitis body surface area (BSA)
time frame: every 6 months for 10 years
measure: Physician reported: Eczema Area and Severity Index (EASI) (calculated)
time frame: every 6 months for 10 years
description: The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe.
measure: Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)
time frame: every 6 months for 10 years
description: 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
measure: Patient reported: Patient global assessments of disease control and severity
time frame: every 6 months for 10 years
description: This determines the progression & severity of the disease
measure: Patient reported: Patient Oriented Eczema Measure (POEM)
time frame: every 6 months for 10 years
measure: Patient reported: Peak pruritus (itch) NRS
time frame: every 6 months for 10 years
measure: Patient reported: Skin pain NRS
time frame: every 6 months for 10 years
measure: Patient reported: Fatigue NRS
time frame: every 6 months for 10 years
measure: Patient reported: Dermatology Life Quality Index (DLQI)
time frame: every 6 months for 10 years
measure: Patient reported: Work Productivity and Activity Impairment (WPAI)
time frame: every 6 months for 10 years
measure: Patient reported: Atopic dermatitis control tool (ADCT)
time frame: every 6 months for 10 years
measure: Patient reported: Itch triggers (PROMIS)
time frame: every 6 months for 10 years
measure: Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)
time frame: 6 months for 10 years
arm group label: Atopic Dermatitis
description: Pts presenting to enrolling sites across in North America and select European countries are invited to enroll if eligible
intervention type: Other
intervention name: Observational Non-Interventional Registry
description: Observational Non-Interventional Registry
arm group label: Atopic Dermatitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No