Psoriasis Longitudinal Assessment and Registry

  • STATUS
    Recruiting
  • End date
    Dec 31, 2030
  • participants needed
    16000
  • sponsor
    Janssen Scientific Affairs, LLC
Updated on 7 September 2021
cyclosporine
methotrexate
psoriasis
secukinumab
guselkumab
ustekinumab
infliximab
arthritis
brodalumab
ixekizumab
puva
psoralen
interleukin-17
plaque psoriasis
acitretin
biological drug

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.

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.

Details
Condition Psoriasis, PSORIATIC ARTHRITIS, Psoriasis and Psoriatic Disorders
Treatment Infliximab, Guselkumab, ustekinumab, Biological therapies other than infliximab, ustekinumab and guselkumab, Conventional systemic agents
Clinical Study IdentifierNCT00508547
SponsorJanssen Scientific Affairs, LLC
Last Modified on7 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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