Psoriasis Longitudinal Assessment and Registry (PSOLAR)

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 12055
• Participant gender: Both

Summary

The purpose of this study is to further evaluate the safety of infliximab and ustekinumab in patients with plaque psoriasis, and other all forms of psoriasis (such as plaque psoriasis and psoriatic arthritis occurring together). The registry study will track the behavior of the disease in response to other therapies, such as other biologic drugs. The registry will also evaluate clinical outcomes; disease characteristics, including physician reported assessment of psoriatic arthritis (PsA); quality of life, and potential risks for patients who may receive standard therapies for psoriasis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Treatments: Infliximab; Ustekinumab
• Last Updated: 2016-12-02

Criteria

Inclusion Criteria:

• Have a diagnosis of psoriasis

• Are candidates for, or are currently receiving conventional systemic agents (eg, methotrexate, acitretin, cyclosporine or systemic psoralen drug in combination with Ultraviolet A light [PUVA]) or biologic therapy for psoriasis including those with chronic severe (extensive and/or disabling) plaque psoriasis who may be treated with infliximab

• 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 Centocor-sponsored clinical trial with marketed agents