Psoriasis Longitudinal Assessment and Registry (PSOLAR)

March 26, 2024 updated by: Janssen Scientific Affairs, LLC

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

15834

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Caba, Argentina
      • Cipoletti, Neuquén, Argentina
      • Ciudad Autónoma de Buenos Aires, Argentina
      • Lomas de Zamora, Argentina
      • San Miguel, Argentina
  • Australia
      • Fremantle, Australia
      • Melbourne, Australia
      • Miranda, Australia
      • Sydney, Australia
      • Woolloongabba, Australia
  • Austria
      • Althofen, Austria
      • Feldkirch N/a, Austria
      • Graz, Austria
      • Klagenfurt, Austria
      • Klagenfurt Am Woerthersee, Austria
      • Laakirchen, Austria
      • Liezen, Austria
      • St Poelten, Austria
      • Vienna, Austria
      • Villach, Austria
      • Wien, Austria
  • Belgium
      • Brugge, Belgium
      • Bruxelles, Belgium
      • Edegem, Belgium
      • Gent, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Mons, Belgium
  • Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Nanaimo, British Columbia, Canada
      • Surrey, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • New Brunswick
      • Fredericton, New Brunswick, Canada
      • Moncton, New Brunswick, Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
      • Kentville, Nova Scotia, Canada
    • Ontario
      • Barrie, Ontario, Canada
      • Coburg, Ontario, Canada
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • Kitchener, Ontario, Canada
      • London, Ontario, Canada
      • Markham, Ontario, Canada
      • Mississauga, Ontario, Canada
      • Newmarket, Ontario, Canada
      • North Bay, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Peterborough, Ontario, Canada
      • St Catherines, Ontario, Canada
      • Sudbury, Ontario, Canada
      • Toronto, Ontario, Canada
      • Windsor, Ontario, Canada
    • Quebec
      • Drummondville, Quebec, Canada
      • Montreal, Quebec, Canada
  • Chile
      • Santiago, Chile
      • Santiago - Las Condes, Chile
      • Santiago - Macul, Chile
  • Colombia
      • Bogota, Colombia
      • Medellin, Colombia
  • Czechia
      • Brno, Czechia
      • Ceske Budejovice, Czechia
      • Jihlava N/a, Czechia
      • Nachod, Czechia
      • Novy Jicin, Czechia
      • Olomouc, Czechia
      • Pardubice, Czechia
      • Plzen, Czechia
      • Praha 10, Czechia
      • Praha 2, Czechia
      • Praha 5, Czechia
      • Praha 8, Czechia
      • Sumperk, Czechia
      • Usti nad Labem, Czechia
  • Greece
      • Athens, Greece
      • Heraklion, Greece
      • Ioannina, Greece
      • Larisa, Greece
      • Patras, Greece
      • Piraeus-Athens, Greece
      • Thessaloniki, Greece
  • Israel
      • Afula, Israel
      • Beer Sheva, Israel
      • Haifa, Israel
      • Netivot, Israel
      • Petach Tikva, Israel
      • Ramat Gan, Israel
      • Tel Aviv, Israel
  • Japan
      • Hirakata, Japan
      • Hokkaido, Japan
      • Itabashi Ku, Japan
      • Kobe, Japan
      • Kurume, Japan
      • Matsumoto, Japan
      • Oita, Japan
      • Takamatsu, Japan
      • Tokyo, Japan
      • Tsu, Japan
      • Yokosuka, Japan
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
      • Seongnam-si, Korea, Republic of
      • Seoul, Korea, Republic of
      • Sungnam, Korea, Republic of
  • Mexico
      • Estado de Mexico, Mexico
      • Mexico city, Mexico
      • Monterrey, Mexico
      • Zapopan, Mexico
  • Netherlands
      • Alkmaar, Netherlands
      • Amsterdam Zuidoost, Netherlands
      • Breda, Netherlands
      • Deventer, Netherlands
      • Helmond, Netherlands
      • Nijmegen, Netherlands
  • Portugal
      • Braga, Portugal
      • Lisboa, Portugal
      • Porto, Portugal
      • Vila Nova de Gaia, Portugal
  • Slovakia
      • Banska Bystrica, Slovakia
      • Bratislava, Slovakia
      • Kosice, Slovakia
      • Martin, Slovakia
      • Nitra, Slovakia
      • Poprad, Slovakia
      • Presov, Slovakia
      • Trnava, Slovakia
  • Slovenia
      • Celje, Slovenia
      • Izola, Slovenia
      • Kranj, Slovenia
      • Ljubljana, Slovenia
      • Maribor, Slovenia
  • Spain
      • Alcalá de Henares, Spain
      • Bilbao, Spain
      • Granada, Spain
      • Madrid, Spain
      • Majadahonda, Spain
      • Murcia, Spain
      • Salamanca, Spain
      • Santiago de Compostela, Spain
  • Sweden
      • Eskilstuna, Sweden
      • Goteborg, Sweden
      • Kungsbacka, Sweden
      • Stockholm, Sweden
  • Taiwan
      • Kaohsiung, Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
      • Taipei-City, Taiwan
      • Taoyuan County, Taiwan
  • Ukraine
      • Dnepropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Kharkiv, Ukraine
      • Khmelnitskiy, Ukraine
      • Kiev, Ukraine
      • Lugansk, Ukraine
      • Simferopol, Ukraine
      • Uzhgorod, Ukraine
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Florence, Alabama, United States
      • Huntsville, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Rogers, Arkansas, United States
    • California
      • 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
      • Colorado Springs, Colorado, United States
      • Englewood, Colorado, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
      • Farmington, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
      • Wilmington, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • 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
    • Georgia
      • 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
    • Idaho
      • Twin Falls, Idaho, United States
    • Illinois
      • 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
    • Indiana
      • Evansville, Indiana, United States
      • Indianapolis, Indiana, United States
      • New Albany, Indiana, United States
      • Plainfield, Indiana, United States
      • West Lafayette, Indiana, United States
    • Kansas
      • Topeka, Kansas, United States
    • Kentucky
      • Corbin, Kentucky, United States
      • Lexington, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Quincy, Massachusetts, United States
    • Michigan
      • 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
    • Minnesota
      • Eagan, Minnesota, United States
    • Missouri
      • Chesterfield, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Helena, Montana, United States
    • Nevada
      • Henderson, Nevada, United States
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
      • Nashua, New Hampshire, United States
    • New Jersey
      • Belleville, New Jersey, United States
      • East Windsor, New Jersey, United States
      • Hoboken, New Jersey, United States
      • Marlton, New Jersey, United States
      • Rutherford, New Jersey, United States
      • Somerset, New Jersey, United States
      • Verona, New Jersey, United States
      • Wyckoff, New Jersey, United States
    • New York
      • Auburn, New York, United States
      • Bronx, New York, United States
      • Commack, New York, United States
      • East Syracuse, New York, United States
      • Elmhurst, New York, United States
      • Garden City, New York, United States
      • Huntington, New York, United States
      • Lawrence, New York, United States
      • New York, New York, United States
      • Oceanside, New York, United States
      • Rochester, New York, United States
      • Smithtown, New York, United States
      • Staten Island, New York, United States
      • Stony Brook, New York, United States
      • Suffern, New York, United States
      • Syracuse, New York, United States
      • White Plains, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Rocky Mount, North Carolina, United States
      • Wilmington, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
      • Delaware, Ohio, United States
      • Gahanna, Ohio, United States
      • Warren, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Coos Bay, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Exton, Pennsylvania, United States
      • Fort Washington, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Plymouth Meeting, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Fort Mill, South Carolina, United States
      • Piedmont, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Bartlett, Tennessee, United States
      • Bristol, Tennessee, United States
      • Kingsport, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Cedar Hill, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Longview, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Arlington, Virginia, United States
      • Norfolk, Virginia, United States
    • Washington
      • Kennewick, Washington, United States
      • Mount Vernon, Washington, United States
      • Seattle, Washington, United States
      • Tacoma, Washington, United States
      • University Place, Washington, United States
      • Walla Walla, Washington, United States
    • Wisconsin
      • Green Bay, Wisconsin, United States
      • Pleasant Prairie, Wisconsin, United States
      • Sheboygan, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 8 years of follow up for each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At baseline and every 6 months through up to 8 years
Evaluation of Disease Features: Body surface area
Time Frame: At baseline and every 6 months through up to 8 years
At baseline and every 6 months through up to 8 years
Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score
Time Frame: At baseline and every 6 months through up to 8 years
At baseline and every 6 months through up to 8 years
Dermatology Life Quality Index (DLQI) Score
Time Frame: At baseline and every 6 months through up to 8 years
At baseline and every 6 months through up to 8 years
EuroQOL quality of life assessment
Time Frame: At baseline and every 6 months through up to 8 years
At baseline and every 6 months through up to 8 years
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
At baseline and every 6 months up to Month 18 and then every year up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Scientific Affairs, LLC

Investigators

  • Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2007

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 27, 2007

First Submitted That Met QC Criteria

July 27, 2007

First Posted (Estimated)

July 30, 2007

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR013225
  • PSOLAR (Other Identifier: Janssen Scientific Affairs, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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