CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Generalized Pustular Psoriasis (GPP) Pts presenting to enrolling sites across the North America are invited to enroll if eligible |
Outcome Measures
Primary Outcome Measures
- Primary Outcome Measure:GPP epidemiology, presentation, natural history, management, and outcomes [Through study completion, an average of 10 years]
The major clinical outcomes include an assessment of the epidemiology of GPP; to better understand the presentation, natural history, management and outcomes
Secondary Outcome Measures
- Subject Reported - Skin Itch VAS [Every 6 months up to 10 years]
Score: 0-100, with a high score indicating severe skin itch
- Subject Reported - Skin Burning VAS [Every 6 months up to 10 years]
Score: 0-100, with a high score indicating severe skin burning
- Subject Reported - Fatigue VAS [Every 6 months up to 10 years]
Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain
- Subject Reported - Joint Pain VAS [Every 6 months up to 10 years]
Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain
- Subject Reported - European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) [Every 6 months up to 10 years]
This measure determines the health of the subject by answering questions related to mobility, self care,anxiety. depression
- Subject Reported - EQ-VAS [Every 6 months up to 10 years]
0 means worst imaginable health state 100 means best imaginable health state
- Subject Reported - World Health Organization Five Well-Being Index (WHO-5) [Every 6 months up to 10 years]
This measure determines how you have been feeling over the last two weeks.
- Subject Reported - Work Productivity and Activity Impairment (WPAI) [Every 6 months up to 10 years]
This measure determines the effect of your health problems on your ability to work and perform regular activities
- Subject Reported - Audit C [Every 6 months up to 10 years]
It is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders
- Subject Reported - Psoriasis Epidemiology Screening Tool (PEST) [Every 6 months up to 10 years]
This measure is used for screening patients with psoriasis
- Subject Reported - Dermatology Life Quality Index (DLQI) [Every 6 months up to 10 years]
This measure determines how much your skin problem has affected your life in past one week
- Subject Reported - Generalized Pustular Psoriasis Visual Analog Scale (VAS) [Every 6 months up to 10 years]
Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild GPP higher numbers are for severe GPP
- Subject Reported - Plaque Psoriasis VAS [Every 6 months up to 10 years]
Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild plaque psoriasis higher numbers are for severe plaque psoriasis
- Subject Reported - Pain VAS [Every 6 months up to 10 years]
Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain
- Subject Reported - Psoriatic Arthritis VAS [Every 6 months up to 10 years]
Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild psoriatic arthritis higher numbers are for severe psoriatic arthritis
- Subject Reported - Skin Pain VAS [Every 6 months up to 10 years]
Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild skin pain higher numbers are for severe skin pain
- Physician Reported - Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) [Every 6 months up to 10 years]
This tool is used is used for the assessment of disease severity, specifically designed for GPP
- Physician Reported - Generalized Pustular Psoriasis Area Severity Index (GPPASI) [Every 6 months up to 10 years]
This tool is used is used for the assessment of disease severity, specifically designed for GPP
- Physician Reported - Investigator Global Assessment (IGA) [Every 6 months up to 10 years]
Score: 0-4, with high score indicating widespread of psoriasis
Eligibility Criteria
Criteria
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.
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Is willing to provide Personal Information
Exclusion Criteria:
- Any of the following would exclude the subject from participating in the registry:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CorEvitas, LLC | Waltham | Massachusetts | United States | 02451 |
Sponsors and Collaborators
- CorEvitas
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- GPP-510