NCT00508547

Psoriasis Longitudinal Assessment and Registry

A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15,842 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and guselkumab in patients with plaque and other forms of psoriasis. The study also includes patients receiving other therapies, such as non-biologic and other biologic agents. The registry also evaluates patient and disease characteristics, including patient-reported assessment of psoriatic arthritis (PsA); and clinical and quality of life outcomes.

Detailed description

PSOLAR is an ongoing voluntary observational study in which infliximab-exposed patients, ustekinumab-exposed patients, and patients treated with other biologic and non-biologic standard of care therapies have been enrolled internationally and are followed for up to 8 years. Additionally, enrollment is opened to include at least 2000 guselkumab-exposed patients and up to 2000 patients exposed to IL-17 inhibitors. The Registry does not require any study-specific testing, but may capture information collected as part of normal routine care. Patient information is collected at the enrollment visit and about every 6 months thereafter. At enrollment, information on demographics (e.g. gender, and race), medical history and family medical history, details of past and current psoriasis treatments, and current psoriasis medications is collected. At enrollment and each follow-up visit, data are collected regarding physical examination, clinical disease status, Quality of Life assessments, current psoriasis medications, patient-reported PsA assessments, and adverse events. No study agents are administered for the purpose of this registry; all patients receive standard of care treatment as prescribed by the patient's physician.

Conditions

• Psoriasis

Timeline

• Start date: 2007-06-21
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2007-07-30
• Last updated: 2026-04-13

Locations

320 sites across 22 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czechia, Greece, Israel, Japan, Mexico, Netherlands, Portugal, Slovakia, Slovenia, South Korea, Spain, Sweden, Taiwan, Ukraine