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Active, not recruitingNCT00508547PSOLARUpdated Nov 3, 2026

Psoriasis Longitudinal Assessment and Registry

An observational study in Psoriasis, sponsored by Janssen Scientific Affairs, LLC. Active, not recruiting at 320 sites in 22 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Janssen Scientific Affairs, LLC (part of Johnson & Johnson) · Observational

Updated Nov 3, 2026Enrollment updated1 site added+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
21,190
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Psoriasis

Keywords

  • psoriasis
  • psoriatic arthritis
  • skin disease
  • infliximab
  • ustekinumab
  • guselkumab
  • etanercept
  • adalimumab
  • secukinumab
  • ixekizumab
  • brodalumab
  • systemic therapy
  • observational
  • registry
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 21,190 is above the median of 199 across 407 observational studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Janssen Scientific Affairs, LLC is the lead sponsor of 41 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any patient with psoriasis who meets the inclusion criteria will be eligible to participate in this registry.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form
  • Are willing to participate in regular follow-up visits

Exclusion criteria

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 agents or are participating in a Janssen-sponsored clinical trial with marketed agents
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
21,190 participants (actual)
Target follow-up
8 Years
Patient registry
Yes

Groups and cohorts

  • Guselkumab

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

  • Infliximab

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

  • Ustekinumab

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

  • Biological Therapies

    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

    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

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

06

What researchers measure

Primary outcomes

  1. Adverse Events and Serious Adverse Events

    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.

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

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

07

Study locations

320 sites
  • Birmingham, Alabama, United States
  • Florence, Alabama, United States
  • Huntsville, Alabama, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Rogers, Arkansas, United States
  • Bakersfield, California, United States
  • Clovis, California, United States
  • Fountain Valley, California, United States
  • Fresno, California, United States
  • Loma Linda, California, United States
  • Los Angeles, California, United States
  • Mountain View, California, United States
  • Oxnard, California, United States
  • Redding, California, United States
  • Rolling Hills Estates, California, United States
  • San Diego, California, United States
  • San Ramon, California, United States
  • Santa Monica, California, United States
  • Sherman Oaks, California, United States
  • Upland, California, United States
  • Vallejo, California, United States
  • Colorado Springs, Colorado, United States
  • Englewood, Colorado, United States
  • Bridgeport, Connecticut, United States
  • Farmington, Connecticut, United States
  • Newark, Delaware, United States
  • Wilmington, Delaware, United States
  • Washington D.C., District of Columbia, United States
  • Aventura, Florida, United States
  • Bay Pines, Florida, United States
  • Boca Raton, Florida, United States
  • Boynton Beach, Florida, United States
  • Coral Gables, Florida, United States
  • Delray Beach, Florida, United States
  • Dunedin, Florida, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • Melbourne, Florida, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • North Miami Beach, Florida, United States
  • Panama City, Florida, United States
  • Pembroke Pines, Florida, United States
  • Seminole, Florida, United States
  • Tampa, Florida, United States
  • Alpharetta, Georgia, United States
  • Atlanta, Georgia, United States
  • Birmingham, Georgia, United States
  • Carrollton, Georgia, United States
  • Conyers, Georgia, United States
  • Lilburn, Georgia, United States
  • Macon, Georgia, United States
  • Marietta, Georgia, United States
  • Rome, Georgia, United States
  • Twin Falls, Idaho, United States
  • Champaign, Illinois, United States
  • Chicago, Illinois, United States
  • Lincolnshire, Illinois, United States
  • Maywood, Illinois, United States
  • Rolling Meadows, Illinois, United States
  • Schaumburg, Illinois, United States
  • Skokie, Illinois, United States
  • Springfield, Illinois, United States
  • West Dundee, Illinois, United States
  • Winfield, Illinois, United States
  • Evansville, Indiana, United States
  • Indianapolis, Indiana, United States
  • New Albany, Indiana, United States
  • Plainfield, Indiana, United States
  • West Lafayette, Indiana, United States
  • Topeka, Kansas, United States
  • Corbin, Kentucky, United States
  • Lexington, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • Quincy, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Clarkston, Michigan, United States
  • Clinton Township, Michigan, United States
  • Farmington, Michigan, United States
  • Flint, Michigan, United States
  • Fort Gratiot, Michigan, United States
  • Grand Blanc, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Monroe, Michigan, United States
  • Norton Shores, Michigan, United States
  • Troy, Michigan, United States
  • Warren, Michigan, United States
  • Eagan, Minnesota, United States
  • Chesterfield, Missouri, United States
  • St Louis, Missouri, United States
  • Helena, Montana, United States
  • Henderson, Nevada, United States
  • Las Vegas, Nevada, United States
  • Lebanon, New Hampshire, United States
  • Nashua, New Hampshire, United States
  • Belleville, New Jersey, United States
  • East Windsor, New Jersey, United States

Showing the first 100 of 320 sites across 22 countries. Choose a country and city above to see the rest.

08

References and documents

Publications

  • Strober B, Augustin M, Tada Y, Parnell Lafferty K, Krol Y, Skobelev E, Ibrahim F, Fakharzadeh S, Gniadecki R. Characteristics of Real-World Patients with Psoriasis Receiving Guselkumab or Interleukin-17 Inhibitors: Data from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Psoriasis Psoriatic Arthritis. 2026 Aug 12:24755303261477021. doi: 10.1177/24755303261477021. Online ahead of print. PubMed 42602014 ↗
  • Ritchlin CT, Stahle M, Poulin Y, Bagel J, Chakravarty SD, Kafka S, Srivastava B, Langholff W, Gottlieb AB. Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics. BMC Rheumatol. 2019 Nov 28;3:52. doi: 10.1186/s41927-019-0094-3. eCollection 2019. PubMed 31799498 ↗
  • Kavanaugh A, Papp K, Gottlieb AB, de Jong EMGJ, Chakravarty SD, Kafka S, Langholff W, Farahi K, Srivastava B, Scher JU. Demography, baseline disease characteristics, and treatment history of psoriasis patients with self-reported psoriatic arthritis enrolled in the PSOLAR registry. BMC Rheumatol. 2018 Sep 29;2:29. doi: 10.1186/s41927-018-0034-7. eCollection 2018. PubMed 30886979 ↗
  • Singh S, Kalb RE, de Jong EMGJ, Shear NH, Lebwohl M, Langholff W, Hopkins L, Srivastava B, Armstrong AW. Effect of Age of Onset of Psoriasis on Clinical Outcomes with Systemic Treatment in the Psoriasis Longitudinal Assessment and Registry (PSOLAR). Am J Clin Dermatol. 2018 Dec;19(6):879-886. doi: 10.1007/s40257-018-0388-z. PubMed 30267377 ↗
  • Strober BE, Bissonnette R, Fiorentino D, Kimball AB, Naldi L, Shear NH, Goyal K, Fakharzadeh S, Calabro S, Langholff W, You Y, Galindo C, Lee S, Lebwohl MG. Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR]). J Am Acad Dermatol. 2016 May;74(5):851-61.e4. doi: 10.1016/j.jaad.2015.12.017. Epub 2016 Feb 4. PubMed 26853180 ↗
  • Kalb RE, Fiorentino DF, Lebwohl MG, Toole J, Poulin Y, Cohen AD, Goyal K, Fakharzadeh S, Calabro S, Chevrier M, Langholff W, You Y, Leonardi CL. Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). JAMA Dermatol. 2015 Sep;151(9):961-9. doi: 10.1001/jamadermatol.2015.0718. PubMed 25970800 ↗
09

Updates

2 registry updates since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • tabashi City · tabashi City, Japan
Show 1 removed
  • Itabashi Ku · Itabashi Ku, Japan
Nov 3, 2026
Enrollment
20167→21190
Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    1 site added, 1 site removed
    Show site
    • tabashi City · tabashi City, Japan
    Show 1 removed
    • Itabashi Ku · Itabashi Ku, Japan
    Enrollment 20167→21190
    + 1 other change: verification date
  2. Sep 25, 2026
    Minor edits only
    + 2 other changes: verification date and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00508547
Responsible party
Sponsor
First posted
Jul 30, 2007
Start date
Jun 21, 2007
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Nov 3, 2026

Study contacts

Janssen Scientific Affairs, LLC Clinical Trial
study director · Janssen Scientific Affairs, LLC

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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