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Trial record 1 of 1 for:    AD-550
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Corrona Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness

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ClinicalTrials.gov Identifier: NCT04504955
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
CorEvitas

Tracking Information
First Submitted Date July 30, 2020
First Posted Date August 7, 2020
Last Update Posted Date August 7, 2020
Actual Study Start Date July 14, 2020
Estimated Primary Completion Date December 2100   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 5, 2020)
AD epidemiology, presentation, natural history, management, and outcomes [ 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 5, 2020)
  • Percentage of patients with history of comorbidities [ Time Frame: at registry enrollment ]
  • Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) [ Time Frame: every 6 months for 10 years ]
    Score: 0-4, with high score indicating widespread of atopic dermatitis
  • Physician reported: Nail changes due to atopic dermatitis (graduated VAS) [ 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
  • Physician reported: Atopic dermatitis body surface area (BSA) [ Time Frame: every 6 months for 10 years ]
  • Physician reported: Eczema Area and Severity Index (EASI) (calculated) [ 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.
  • Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated) [ 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
  • Patient reported: Patient global assessments of disease control and severity [ Time Frame: every 6 months for 10 years ]
    This determines the progression & severity of the disease
  • Patient reported: Patient Oriented Eczema Measure (POEM) [ Time Frame: every 6 months for 10 years ]
  • Patient reported: Peak pruritus (itch) NRS [ Time Frame: every 6 months for 10 years ]
  • Patient reported: Skin pain NRS [ Time Frame: every 6 months for 10 years ]
  • Patient reported: Fatigue NRS [ Time Frame: every 6 months for 10 years ]
  • Patient reported: Dermatology Life Quality Index (DLQI) [ Time Frame: every 6 months for 10 years ]
  • Patient reported: Work Productivity and Activity Impairment (WPAI) [ Time Frame: every 6 months for 10 years ]
  • Patient reported: Atopic dermatitis control tool (ADCT) [ Time Frame: every 6 months for 10 years ]
  • Patient reported: Itch triggers (PROMIS) [ Time Frame: every 6 months for 10 years ]
  • Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD) [ Time Frame: 6 months for 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Corrona Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness
Official Title Corrona Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness
Brief Summary

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

Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients are enrolled in the Atopic Dermatitis Registry during regularly scheduled office visits clinical encounters. Selected dermatologists are invited to participate as investigators in the Registry.
Condition Atopic Dermatitis
Intervention Other: Observational Non-Interventional Registry
Observational Non-Interventional Registry
Study Groups/Cohorts Atopic Dermatitis
Pts presenting to enrolling sites across in North America and select European countries are invited to enroll if eligible
Intervention: Other: Observational Non-Interventional Registry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: August 5, 2020)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2100
Estimated Primary Completion Date December 2100   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patient has been diagnosed with atopic dermatitis by a dermatologist or a qualified dermatology practitioner
  2. Patient is at least 18 years of age or older
  3. Patient is willing to provide Personal Information
  4. Patient meets ONE (1) of the following conditions at the time of enrollment:

    1. Has started taking a new Eligible Medication within the 12 months prior to the Enrollment visit.
    2. Is prescribed a new Eligible Medication at the Enrollment visit.
    3. Is NOT being treated with an Eligible Medication at the time of enrollment but has an Eczema Area Severity Index score ≥ 12 AND a Validated Investigator Global Assessment scale for Atopic Dermatitis score ≥ 3.

Exclusion Criteria:

1)Patient must not be participating in or planning to participate in a double-blind randomized trial for a systemic atopic dermatitis medication. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.

Eligible Medications Grouped by Drug Class & Diagnosis Non-Biologics - Azathioprine oral (Imuran, Azasan), Cyclosporine oral (Sandimmune, Neoral, Gengraf), Methotrexate injection (Rasuvo, Otrexup), Methotrexate oral (Trexall, Rheumatrex), Mycophenolate mofetil oral (CellCept), Mycophenolic acid oral (Myfortic), Tacrolimus oral (Prograf)

Small Molecules - Apremilast oral (Otezla), Baricitinib oral (Olumiant), Tofacitinib oral (Xeljanz, Xeljanz XR), Upadacitinib oral (Rinvoq), Other small molecule for AD

Biologics - Dupilumab injection (Dupixent), Ixekizumab injection (Taltz), Omalizumab injection (Xolair ), Risankizumab-rzaa injection (Skyrizi), Secukinumab injection (Cosentyx), Ustekinumab injection (Stelara ), Other biologic for AD

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04504955
Other Study ID Numbers Corrona-AD-550
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party CorEvitas
Study Sponsor CorEvitas
Collaborators Not Provided
Investigators Not Provided
PRS Account CorEvitas
Verification Date July 2020