Generalized Pustular Psoriasis
Conditions
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
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.
Interventions
None listed
Sponsors
CorEvitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A subject must meet all the following criteria to participate in the registry: 1. Has been diagnosed with GPP by a dermatologist or a qualified dermatology practitioner. 2. Is at least 18 years of age and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted. 3. Is willing to provide consent for participation in the registry. 4. Is willing to provide Personal Information
Exclusion criteria
* Any of the following would exclude the subject from participating in the registry: 1. 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. 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure:GPP epidemiology and Presentation | 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 and natural history. |
| GPP management, and outcomes | Through study completion, an average of 10 years | The major clinical outcome include an assessment of the epidemiology of GPP; to better understand the management and outcomes. |
Countries
United States
Contacts
CONTACTGeneralized Pustular Psoriasis Registry Team
Outcome results
None listed