The CorEvitas Psoriasis (PSO) Registry

February 5, 2026 updated by: CorEvitas

CorEvitas Psoriasis (PSO) Registry

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Based on the operating procedures established by the Corrona Rheumatoid Arthritis (RA) Registry, the Psoriasis Registry will use a parallel structure based on a design and strategy developed by Corrona, LLC. This registry will be cooperatively managed by scientific, operational, and quality leaders at Corrona and medical leaders appointed by the National Psoriasis Foundation (NPF).

Investigators may enroll patients who have started on or switched to a systemic agent for psoriasis within the previous twelve months. Currently approved subcutaneous biologics are indicated for adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The currently approved intravenous biologic agent is indicated for adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy, and when other systemic therapies are medically less appropriate. All patients will receive standard of care treatments prescribed by the investigator, in accordance with the FDA-approved drug labeling, and all treatment decisions are the sole responsibility of the investigator.

This study will be conducted at approximately 200 sites across North America. Sites are assessed and selected through interviews with potential investigators and a corresponding site feasibility survey that includes information on the investigator's qualifications, previous research experience, and the availability of support staff, sub-investigators, and patient population.

The Corrona Psoriasis Registry is a longitudinal, observational study; therefore, the duration is indefinite with no pre-determined stop date. The enrollment period is estimated to take approximately four years, and subjects will be followed for a minimum of eight years beginning from the time the subject is enrolled.

The design is a prospective, multicenter, observational registry for subjects with psoriasis. Longitudinal follow-up data is obtained via Corrona Questionnaires completed by both subjects and their treating dermatologists (also known as "Providers" for a Corrona registry study) every 6 months (+/- 30 days). The registry is designed to collect data on patient demographics, smoking history, disease duration, disease severity, disease activity, history of prior psoriasis treatment, comorbidities, hospitalizations, adverse events of special interest, medication use, and laboratory results.

The registry is linked to external data sources including the Centers for Disease Control's National Death Index (NDI), the Centers for Medicare and Medicaid Services (CMS), and other administrative data sources to support drug safety monitoring and other research activities.

Any adverse events that are spontaneously volunteered by the subject or discovered as a result of general questioning by the investigator should be recorded on the Provider Follow-up Questionnaire for that visit.

Study Type

Observational

Enrollment (Estimated)

10000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the CorEvitas Psoriasis Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below.

Inclusion Criteria:

The patient must:

  1. Have been diagnosed with psoriasis by a dermatologist.
  2. Be at least 18 years of age or older.
  3. Be willing and able to provide written consent for participation in the registry.
  4. 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.
  5. Meet one of the following criteria.

Have started on or switched to a systemic psoriasis treatment within the previous 12 months†▲:

Exclusion Criteria:

1. Patient is participating in or planning to participate in a double-blind randomized of a psoriasis drug. Of note, concurrent participation in another observational registry or open-label Phase 3b/4 trial is not excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Psoriasis
Pts presenting to enrolling sites across the US are invited to enroll if eligible

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events (AEs) or serious adverse events (SAEs).
Time Frame: A minimum of 8 years from last patient enrolled

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.
A minimum of 8 years from last patient enrolled

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease burden: Psoriatic area and severity index (PASI)
Time Frame: every 6 months for 8 years
every 6 months for 8 years
Disease burden: Investigators Global Assessment (IGA)
Time Frame: every 6 months for 8 years
every 6 months for 8 years
Disease burden: Body surface area (BSA)
Time Frame: every 6 months for 8 years
every 6 months for 8 years
Percentage of patients with history of comorbidities
Time Frame: time frame: at registry enrollment
time frame: at registry enrollment
Physician reported: Fitzpatrick skin type
Time Frame: time frame: every 6 months for 8 years
time frame: every 6 months for 8 years
Patient reported: EuroQOL-5D-3L
Time Frame: time frame: every 6 months for 8 years
time frame: every 6 months for 8 years
Patient reported: Dermatology Quality of Life index (DLQI)
Time Frame: time frame: every 6 months for 8 years
time frame: every 6 months for 8 years
Patient reported: Work productivity and Activity Impairment (WPAI)
Time Frame: time frame: every 6 months for 8 years
time frame: every 6 months for 8 years
Patient reported: Pain, Fatigue, Itch score on Visual Analog Scale (VAS) (1-100)
Time Frame: time frame: every 6 months for 8 years
time frame: every 6 months for 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorEvitas

Investigators

  • Study Director: Jeffrey Greenberg, MD, MPH, CorEvitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Estimated)

December 1, 2100

Study Completion (Estimated)

December 1, 2100

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimated)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CorEvitas-PSO-500

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.

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