Lexington, Kentucky 40504

  • Psoriasis

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Have a diagnosis of psoriasis - Are currently taking Tremfya or an Interleukin-17 (IL-17) inhibitor (example, secukinumab, ixekizumab, brodalumab) or will be initiating treatment with Tremfya or an IL-17 inhibitor at the time of their enrollment. Patients who completed prior participation in PSOLAR may re-enroll as long as they are receiving or initiating treatment with Tremfya or an IL-17 inhibitor - Ability to understand and sign an informed consent form - Are willing to participate in regular follow-up visits Exclusion Criteria: - Refuse to consent or are unwilling to respond to request for a long term information within the required time frame - Are participating or have already planned to participate in a clinical trial with non-marketed investigational agents or are participating in a Janssen-sponsored clinical trial with marketed agents


NCT ID:

NCT00508547


Primary Contact:

Study Director
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email: JNJ.CT@sylogent.com


Backup Contact:

N/A


Location Contact:

Lexington, Kentucky 40504
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 02, 2021

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