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Active, Not Recruiting

NCT Number: NCT00508547

Psoriasis Longitudinal Assessment and Registry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Adverse Events and Serious Adverse Events

    Time frame: Up to 8 years of follow up for each patient

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; suspected transmission of any infectious agent via medicinal product; any important medical events. All adverse events, including those of special interest, such as malignancies;TB;opportunistic infections;depression;hypersensitivity reactions; autoimmune disease; neurologic or demyelinating events; congestive heart failure; gastrointestinal events; demyelinating disease, hepatotoxicity; hematologic events; unexpected reaction to a vaccine;cerebrovascular accident; transient ischemic attack; confirmed myocardial infarction; acquired immunodeficiency syndrome will be documented.

Secondary outcomes

  1. Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score

    Time frame: At baseline and every 6 months through up to 8 years

  2. Evaluation of Disease Features: Body surface area

    Time frame: At baseline and every 6 months through up to 8 years

  3. Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score

    Time frame: At baseline and every 6 months through up to 8 years

  4. Dermatology Life Quality Index (DLQI) Score

    Time frame: At baseline and every 6 months through up to 8 years

  5. EuroQOL quality of life assessment

    Time frame: At baseline and every 6 months through up to 8 years

  6. Hospital Anxiety and Depression Scale (HADS) Score

    Time frame: At baseline and every 6 months up to Month 18 and then every year up to 8 years

Sponsors and collaborators

Lead sponsor

Janssen Scientific Affairs, LLC

Industry

Registry information

Official study title

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

Acronym: PSOLAR

Important dates

Study start
2007
Primary completion
2029
Study completion
2030
First posted
Jul 30, 2007
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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