The CorEvitas Psoriasis (PSO) Registry
ConditionPsoriasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCorEvitas
About this trial
The primary objective of the CorEvitas Psoriasis Registry is to study the comparative safety of approved psoriasis therapies in a North American cohort of psoriasis subjects treated by dermatologists. This includes assessing the incidence and nature of adverse events of special interest, including malignancy, in a real world population of psoriasis patients on new biologic therapies (e.g. secukinumab). Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, current treatment practices, and comparative effectiveness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Have been diagnosed with psoriasis by a dermatologist.
Be at least 18 years of age or older.
Be willing and able to provide written consent for participation in the registry.
Be willing and able to provide Personally Identifiable Information (PII) that includes the following types of personal information at a minimum: 1) Full Name and 2) Date of Birth.
Trial population
Patients are enrolled in the Psoriasis Registry during regularly-scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry. Physicians are selected carefully in an effort to ensure enrollment of subjects that represent a reasonable representation of a cross-section of the population throughout North America with Psoriasis. All potential sites are screened for clinical research experience and adherence to Good Clinical Practice (GCP) guidelines.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 1 trial groupGroup A: Psoriasis
Trial outcomes
Primary outcomes
1
Number of patients with adverse events (AEs) or serious adverse events (SAEs).
Targeted events include malignancy, cardiovascular disease, serious infection, inflammatory bowel disease, gastrointestinal perforation, neurological events, hepatic events, and general serious adverse events. An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame
A minimum of 8 years from last patient enrolledSecondary outcomes
1
Disease burden: Psoriatic area and severity index (PASI)
Time frame
every 6 months for 8 years2
Disease burden: Investigators Global Assessment (IGA)
Time frame
every 6 months for 8 years3
Disease burden: Body surface area (BSA)
Time frame
every 6 months for 8 years4
Percentage of patients with history of comorbidities
Time frame
time frame: at registry enrollment Source ClinicalTrials.gov