Clinical trial NCT06100991: CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
Official title: CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Generalized Pustular Psoriasis
Lead sponsor: CorEvitas
Sponsor class: NETWORK
First posted: 2023-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Primary Outcome Measure:GPP epidemiology, presentation, natural history, management, and outcomes
timeFrame: Through study completion, an average of 10 years
Secondary outcomes:
measure: Subject Reported - Skin Itch NRS
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Skin Burning NRS
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Fatigue NRS
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Joint Pain NRS
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - EQ-VAS
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - World Health Organization Five Well-Being Index (WHO-5)
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Work Productivity and Activity Impairment (WPAI)
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Audit C
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Psoriasis Epidemiology Screening Tool (PEST)
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Dermatology Life Quality Index (DLQI)
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Generalized Pustular Psoriasis Numeric Rating Scale (NRS)
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Plaque Psoriasis NRS
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Pain VAS
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Psoriatic Arthritis NRS
timeFrame: Every 6 months up to 10 years
measure: Subject Reported - Skin Pain NRS
timeFrame: Every 6 months up to 10 years
measure: Physician Reported - Generalized Pustular Psoriasis Physician Global Assessment (GPPGA)
timeFrame: Every 6 months up to 10 years
measure: Physician Reported - Generalized Pustular Psoriasis Area Severity Index (GPPASI)
timeFrame: Every 6 months up to 10 years
measure: Physician Reported - Investigator Global Assessment (IGA)
timeFrame: Every 6 months up to 10 years
Other outcomes:
Locations:
city: Waltham
country: United States
facility: CorEvitas, LLC
state: Massachusetts
Study officials:
References: