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

NCT06100991 · CorEvitas
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-09-19
Estimated completion: 2099-12
Last updated: 2026-02-09
Primary outcomes
  • Primary Outcome Measure:GPP epidemiology and Presentation (Through study completion, an average of 10 years)
  • GPP management, and outcomes (Through study completion, an average of 10 years)
Sponsor
CorEvitas · network
Contacts & investigators
ContactCathy Cheney · contact · corevitasregistrytrials@corevitas.com · +1 508 408 5433
ContactJeffrey Greenberg, MD · contact
All locations (1)
CorEvitas, LLCRecruiting
Waltham, Massachusetts, United States
CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry · TrialPath