The CorEvitas Psoriasis (PSO) Registry

NCT02707341 | Enrolling By Invitation

• 1 other identifier: CorEvitas-PSO-500
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Psoriasis

Keywords

psoriasis; disease registry

Outcome Measures

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.

  A minimum of 8 years from last patient enrolled

Secondary Outcomes (9)

• Disease burden: Psoriatic area and severity index (PASI)

  every 6 months for 8 years

• Disease burden: Investigators Global Assessment (IGA)

  every 6 months for 8 years

• Disease burden: Body surface area (BSA)

  every 6 months for 8 years

• Percentage of patients with history of comorbidities

  time frame: at registry enrollment

• Physician reported: Fitzpatrick skin type

  time frame: every 6 months for 8 years

Study Arms (1)

Psoriasis

Pts presenting to enrolling sites across the US are invited to enroll if eligible

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• The patient must:
• 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.
• Meet one of the following criteria.
• Have started on or switched to a systemic psoriasis treatment within the previous 12 months†▲:
• \. 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.

Sponsors & Collaborators

• CorEvitas: lead

Related Publications (4)

• Armstrong AW, Feldman SR, Fitzgerald T, Alkousakis T, Sima A, Li A, Kang HJ, Main SI, Khattri S, Stein Gold L. Patient-Reported Outcomes by Baseline Body Surface Area Involvement Among Individuals Initiating Biologic Therapy: Results from the CorEvitas Psoriasis Registry. Dermatol Ther (Heidelb). 2025 Aug;15(8):2117-2130. doi: 10.1007/s13555-025-01456-5. Epub 2025 Jun 11.

  PMID: 40498388 DERIVED

• Strober B, Zhong Y, Sima A, Beeghly A, Eckmann T, Balagula E, Zhuo J, Lebwohl M. Criteria for Identifying Candidates for Systemic Psoriasis Treatment in the Real World: Application of the International Psoriasis Council Guidelines in Patients in North America. J Psoriasis Psoriatic Arthritis. 2024 Nov 21;10(1):22-27. doi: 10.1177/24755303241302070. eCollection 2025 Jan.

  PMID: 39583219 DERIVED

• McLean RR, Sima AP, Beaty S, Jones EA, Eckmann T, Low R, McClung L, Spitzer RL, Stark J, Armstrong A. Durability of Near-Complete Skin Clearance in Patients with Psoriasis Using Systemic Biologic Therapies: Real-World Evidence from the CorEvitas Psoriasis Registry. Dermatol Ther (Heidelb). 2023 Nov;13(11):2753-2768. doi: 10.1007/s13555-023-01028-5. Epub 2023 Sep 27.

  PMID: 37759099 DERIVED

• McLean RR, Sima AP, Beaty S, Low R, Spitzer RL, Stark JL, Lesser E, Lee E, Armstrong A. Skin Clearance is Associated with Reduced Treatment Failure in Patients with Psoriasis: Real-World Evidence from the CorEvitas Psoriasis Registry. Dermatol Ther (Heidelb). 2023 Nov;13(11):2739-2751. doi: 10.1007/s13555-023-01027-6. Epub 2023 Sep 27.

  PMID: 37755689 DERIVED

Related Links

• CorEvitas home page

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeffrey Greenberg, MD, MPH

  CorEvitas

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: March 14, 2016
• Study Start: April 1, 2015
• Primary Completion (Estimated): December 1, 2100
• Study Completion (Estimated): December 1, 2100
• Last Updated: February 9, 2026

Record last verified: 2026-01