CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Waltham, Massachusetts, United States, 02451
- CorEvitas, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Subjects are enrolled in the GPP Registry during regularly scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry.
Description
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 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.
- Is willing to provide consent for participation in the registry.
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
|---|
|
Generalized Pustular Psoriasis (GPP)
Pts presenting to enrolling sites across the North America are invited to enroll if eligible |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome Measure:GPP epidemiology and Presentation
Time Frame: 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. |
Through study completion, an average of 10 years
|
|
GPP management, and outcomes
Time Frame: 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. |
Through study completion, an average of 10 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CorEvitas GPP-510
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.