Psoriasis Longitudinal Assessment and Registry (PSOLAR)

Janssen (J&J Innovative Medicine)

Status: Active, not recruiting

Conditions: Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT00508547

CR013225

C0168Z03 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15,842 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of psoriasis
• Incident or prevalent users of Tremfya or an IL-17 inhibitor (eg, secukinumab, ixekizumab, brodalumab, bimekizumab) at the time of their enrollment. Incident users are defined as those participants starting treatment within 30 days before or after the enrollment visit and prevalent users are defined as those who are on treatment greater than 30 days prior to the enrollment visit
• 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 requests for 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

Trial design

15,842 participants in 6 patient groups

Guselkumab

Description:

Participants will receive guselkumab as prescribed by a physician according to standard of care for psoriasis.

Infliximab

Description:

Participants will receive infliximab as prescribed by a physician according to standard of care for psoriasis.

Ustekinumab

Description:

Participants will receive ustekinumab as prescribed by a physician according to standard of care for psoriasis.

Biological Therapies

Description:

Participants will receive biological therapies other than infliximab, ustekinumab, guselkumab, and IL-17 inhibitors as prescribed by a physician for psoriasis. Participants will not receive any intervention as a part of this study.

Conventional Systemic Agents

Description:

Participants will receive conventional systemic agents as prescribed by a physician for psoriasis. Participants will not receive any intervention as a part of this study.

IL-17 Inhibitor

Description:

Participants will receive an IL-17 inhibitor as prescribed by a physician according to standard of care for psoriasis.