CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry

Study Overview
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Brief Summary
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Prospective, observational registry for subjects with GPP under the care of a dermatology investigator.Approximately 200 subjects and 75 clinical sites in North America will be recruited to participate with no defined upper limit for either target

Detailed Description
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The objective of the registry is to obtain information on the treatment patterns, disease activity progression, and the development of comorbidities and adverse events in a cohort of patients with GPP. Data collected will be used to better characterize the natural history and longitudinal trajectory of the disease. This will be done through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of GPP for the purposes of clinical, market, or outcomes research. 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.

Official Title
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CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry

Conditions
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Generalized Pustular Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject must meet all the following criteria to participate in the registry: Has been diagnosed with GPP by a dermatologist or a qualified dermatology practitioner. Is at least 18 years of age. Is willing to provide Personal Information Exclusion Criteria: Any of the following would exclude the subject from participating in the registry: Is participating or planning to participate in a blinded clinical trial evaluating a systemic agent for the treatment or prevention of flares related to GPP. Is enrolled in another CorEvitas registry for a dermatological condition. Subjects enrolled in another CorEvitas registry must be exited to be eligible for enrollment into the GPP Registry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Generalized Pustular Psoriasis (GPP)<br>Pts presenting to enrolling sites across the North America are invited to enroll if eligible | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measure:GPP epidemiology, presentation, natural history, management, and outcomes | The major clinical outcomes include an assessment of the epidemiology of GPP; to better understand the presentation, natural history, management and outcomes | Through study completion, an average of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Reported - Skin Itch NRS | Score: 0-100, with a high score indicating severe skin itch | Every 6 months up to 10 years | 
| Subject Reported - Skin Burning NRS | Score: 0-100, with a high score indicating severe skin burning | Every 6 months up to 10 years | 
| Subject Reported - Fatigue NRS | Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain | Every 6 months up to 10 years | 
| Subject Reported - Joint Pain NRS | Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain | Every 6 months up to 10 years | 
| Subject Reported - European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) | This measure determines the health of the subject by answering questions related to mobility, self care,anxiety. depression | Every 6 months up to 10 years | 
| Subject Reported - EQ-VAS | 0 means worst imaginable health state 100 means best imaginable health state | Every 6 months up to 10 years | 
| Subject Reported - World Health Organization Five Well-Being Index (WHO-5) | This measure determines how you have been feeling over the last two weeks. | Every 6 months up to 10 years | 
| Subject Reported - Work Productivity and Activity Impairment (WPAI) | This measure determines the effect of your health problems on your ability to work and perform regular activities | Every 6 months up to 10 years | 
| Subject Reported - Audit C | It is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders | Every 6 months up to 10 years | 
| Subject Reported - Psoriasis Epidemiology Screening Tool (PEST) | This measure is used for screening patients with psoriasis | Every 6 months up to 10 years | 
| Subject Reported - Dermatology Life Quality Index (DLQI) | This measure determines how much your skin problem has affected your life in past one week | Every 6 months up to 10 years | 
| Subject Reported - Generalized Pustular Psoriasis Numeric Rating Scale (NRS) | Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild GPP higher numbers are for severe GPP | Every 6 months up to 10 years | 
| Subject Reported - Plaque Psoriasis NRS | Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild plaque psoriasis higher numbers are for severe plaque psoriasis | Every 6 months up to 10 years | 
| Subject Reported - Pain VAS | Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain | Every 6 months up to 10 years | 
| Subject Reported - Psoriatic Arthritis NRS | Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild psoriatic arthritis higher numbers are for severe psoriatic arthritis | Every 6 months up to 10 years | 
| Subject Reported - Skin Pain NRS | Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild skin pain higher numbers are for severe skin pain | Every 6 months up to 10 years | 
| Physician Reported - Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) | This tool is used is used for the assessment of disease severity, specifically designed for GPP | Every 6 months up to 10 years | 
| Physician Reported - Generalized Pustular Psoriasis Area Severity Index (GPPASI) | This tool is used is used for the assessment of disease severity, specifically designed for GPP | Every 6 months up to 10 years | 
| Physician Reported - Investigator Global Assessment (IGA) | Score: 0-4, with high score indicating widespread of psoriasis | Every 6 months up to 10 years |