PsoriasisPSOLARNCT00508547
Psoriasis Longitudinal Assessment and Registry
An observational study of Psoriasis, run by Janssen Scientific Affairs, LLC at 320 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Psoriasis
- How many people
- 20,167 participants
- Where
- 320 sitesin 22 countries
- Study dates
- 21 Jun 2007to 31 Dec 2030
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with psoriasis who meets the inclusion criteria will be eligible to participate in this registry.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
320 sites in 22 countries.
320 sites in 22 countries
United States167 sites
Study site
Akron, Ohio
Study site
Alpharetta, Georgia
Study site
Ann Arbor, Michigan
Study site
Arlington, Texas
Study site
Arlington, Virginia
Study site
Atlanta, Georgia
Study site
Auburn, New York
Study site
Aventura, Florida
Study site
Bakersfield, California
Study site
Bartlett, Tennessee
Study site
Bay Pines, Florida
Study site
Belleville, New Jersey
Study site
Birmingham, Alabama
Study site
Birmingham, Georgia
Study site
Boca Raton, Florida
Study site
Boston, Massachusetts
Study site
Boynton Beach, Florida
Study site
Bridgeport, Connecticut
Study site
Bristol, Tennessee
Study site
Carrollton, Georgia
Study site
Cedar Hill, Texas
Study site
Champaign, Illinois
Study site
Chapel Hill, North Carolina
Study site
Charleston, South Carolina
Study site
Chesterfield, Missouri
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Clarkston, Michigan
Study site
Clinton Township, Michigan
Study site
Clovis, California
Study site
Colorado Springs, Colorado
Study site
Columbus, Ohio
Study site
Commack, New York
Study site
Conyers, Georgia
Study site
Coos Bay, Oregon
Study site
Coral Gables, Florida
Study site
Corbin, Kentucky
Study site
Dallas, Texas
Study site
Dayton, Ohio
Study site
Delaware, Ohio
Study site
Delray Beach, Florida
Study site
Dunedin, Florida
Study site
Eagan, Minnesota
Study site
East Syracuse, New York
Study site
East Windsor, New Jersey
Study site
Elmhurst, New York
Study site
Englewood, Colorado
Study site
Evansville, Indiana
Study site
Exton, Pennsylvania
Study site
Farmington, Connecticut
Study site
Farmington, Michigan
Study site
Flint, Michigan
Study site
Florence, Alabama
Study site
Fort Gratiot, Michigan
Study site
Fort Mill, South Carolina
Study site
Fort Washington, Pennsylvania
Study site
Fountain Valley, California
Study site
Fresno, California
Study site
Gahanna, Ohio
Study site
Garden City, New York
Study site
Grand Blanc, Michigan
Study site
Grand Rapids, Michigan
Study site
Green Bay, Wisconsin
Study site
Helena, Montana
Study site
Henderson, Nevada
Study site
Hoboken, New Jersey
Study site
Hollywood, Florida
Study site
Houston, Texas
Study site
Huntington, New York
Study site
Huntsville, Alabama
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Kennewick, Washington
Study site
Kingsport, Tennessee
Study site
Las Vegas, Nevada
Study site
Lawrence, New York
Study site
Lebanon, New Hampshire
Study site
Lexington, Kentucky
Study site
Lilburn, Georgia
Study site
Lincolnshire, Illinois
Study site
Loma Linda, California
Study site
Longview, Texas
Study site
Los Angeles, California
Study site
Macon, Georgia
Study site
Marietta, Georgia
Study site
Marlton, New Jersey
Study site
Maywood, Illinois
Study site
Melbourne, Florida
Study site
Miami, Florida
Study site
Monroe, Michigan
Study site
Mount Vernon, Washington
Study site
Mountain View, California
Study site
Naples, Florida
Study site
Nashua, New Hampshire
Study site
New Albany, Indiana
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Newark, Delaware
Study site
Norfolk, Virginia
Study site
North Miami Beach, Florida
Study site
Norton Shores, Michigan
Study site
Oceanside, New York
Study site
Oklahoma City, Oklahoma
Study site
Oxnard, California
Study site
Panama City, Florida
Study site
Pembroke Pines, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Piedmont, South Carolina
Study site
Pittsburgh, Pennsylvania
Study site
Plainfield, Indiana
Study site
Pleasant Prairie, Wisconsin
Study site
Plymouth Meeting, Pennsylvania
Study site
Portland, Oregon
Study site
Quincy, Massachusetts
Study site
Raleigh, North Carolina
Study site
Redding, California
Study site
Rochester, New York
Study site
Rocky Mount, North Carolina
Study site
Rogers, Arkansas
Study site
Rolling Hills Estates, California
Study site
Rolling Meadows, Illinois
Study site
Rome, Georgia
Study site
Rutherford, New Jersey
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
San Ramon, California
Study site
Santa Monica, California
Study site
Schaumburg, Illinois
Study site
Scottsdale, Arizona
Study site
Seattle, Washington
Study site
Seminole, Florida
Study site
Sheboygan, Wisconsin
Study site
Sherman Oaks, California
Study site
Skokie, Illinois
Study site
Smithtown, New York
Study site
Somerset, New Jersey
Study site
Spartanburg, South Carolina
Study site
Springfield, Illinois
Study site
St Louis, Missouri
Study site
Staten Island, New York
Study site
Stony Brook, New York
Study site
Suffern, New York
Study site
Syracuse, New York
Study site
Tacoma, Washington
Study site
Tampa, Florida
Study site
The Bronx, New York
Study site
Topeka, Kansas
Study site
Troy, Michigan
Study site
Tucson, Arizona
Study site
Twin Falls, Idaho
Study site
University Place, Washington
Study site
Upland, California
Study site
Vallejo, California
Study site
Verona, New Jersey
Study site
Walla Walla, Washington
Study site
Warren, Michigan
Study site
Warren, Ohio
Study site
Washington D.C., District of Columbia
Study site
West Dundee, Illinois
Study site
West Lafayette, Indiana
Study site
White Plains, New York
Study site
Williamsville, New York
Study site
Wilmington, Delaware
Study site
Wilmington, North Carolina
Study site
Winfield, Illinois
Study site
Wyckoff, New Jersey
Canada30 sites
Study site
Barrie, Ontario
Study site
Calgary, Alberta
Study site
Coburg, Ontario
Study site
Drummondville, Quebec
Study site
Edmonton, Alberta
Study site
Fredericton, New Brunswick
Study site
Greater Sudbury, Ontario
Study site
Halifax, Nova Scotia
Study site
Hamilton, Ontario
Study site
Kentville, Nova Scotia
Study site
Kingston, Ontario
Study site
Kitchener, Ontario
Study site
London, Ontario
Study site
Markham, Ontario
Study site
Mississauga, Ontario
Study site
Moncton, New Brunswick
Study site
Montreal, Quebec
Study site
Nanaimo, British Columbia
Study site
Newmarket, Ontario
Study site
North Bay, Ontario
Study site
Ottawa, Ontario
Study site
Peterborough, Ontario
Study site
Québec, Quebec
Study site
Saint Catherines, Ontario
Study site
St. John's, Newfoundland and Labrador
Study site
Surrey, British Columbia
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Study site
Windsor, Ontario
Study site
Winnipeg, Manitoba
Czechia11 sites
Study site
Brno
Study site
České Budějovice
Study site
Jihlava
Study site
Náchod
Study site
Nový Jičín
Study site
Olomouc
Study site
Pardubice
Study site
Pilsen
Study site
Prague
Study site
Šumperk
Study site
Ústí nad Labem
Japan11 sites
Study site
Hirakata
Study site
Hokkaido
Study site
Itabashi Ku
Study site
Kobe
Study site
Kurume
Study site
Matsumoto
Study site
Ōita
Study site
Takamatsu
Study site
Tokyo
Study site
Tsu
Study site
Yokosuka
Austria8 sites
Study site
Althofen
Study site
Feldkirch
Study site
Graz
Study site
Klagenfurt
Study site
Laakirchen
Study site
Sankt Pölten
Study site
Vienna
Study site
Villach
Greece8 sites
Study site
Athens
Study site
Heraklion
Study site
Ioannina
Study site
Larissa
Study site
Pátrai
Study site
Piraeus-Athens
Study site
Psychikó
Study site
Thessaloniki
Slovakia8 sites
Study site
Banská Bystrica
Study site
Bratislava
Study site
Košice
Study site
Martin
Study site
Nitra
Study site
Poprad
Study site
Prešov
Study site
Trnava
Spain8 sites
Study site
Alcalá de Henares
Study site
Bilbao
Study site
Granada
Study site
Madrid
Study site
Majadahonda
Study site
Murcia
Study site
Salamanca
Study site
Santiago de Compostela
Ukraine8 sites
Study site
Dnipro
Study site
Donetsk
Study site
Kharkiv
Study site
Khmelnitskiy
Study site
Kiev
Study site
Luhansk
Study site
Simferopol
Study site
Uzhhorod
Belgium7 sites
Study site
Bruges
Study site
Brussels
Study site
Edegem
Study site
Ghent
Study site
Leuven
Study site
Liège
Study site
Mons
Israel7 sites
Study site
Afula
Study site
Beersheba
Study site
Haifa
Study site
Netivot
Study site
Petah Tikva
Study site
Ramat Gan
Study site
Tel Aviv
Netherlands6 sites
Study site
Alkmaar
Study site
Amsterdam-Zuidoost
Study site
Breda
Study site
Deventer
Study site
Helmond
Study site
Nijmegen
Argentina5 sites
Study site
Buenos Aires
Study site
CABA
Study site
Cipolletti
Study site
Lomas de Zamora
Study site
San Miguel
Australia5 sites
Study site
Fremantle
Study site
Melbourne
Study site
Miranda
Study site
Sydney
Study site
Woolloongabba
Slovenia5 sites
Study site
Celje
Study site
Izola
Study site
Kranj
Study site
Ljubljana
Study site
Maribor
South Korea5 sites
Study site
Busan
Study site
Gyeonggi-do
Study site
Seongnam-si
Study site
Seoul
Study site
Sungnam
Mexico4 sites
Study site
Estado de México
Study site
Mexico City
Study site
Monterrey
Study site
Zapopan
Portugal4 sites
Study site
Braga
Study site
Lisbon
Study site
Porto
Study site
Vila Nova de Gaia
Sweden4 sites
Study site
Eskilstuna
Study site
Gothenburg
Study site
Kungsbacka
Study site
Stockholm
Taiwan4 sites
Study site
Kaohsiung City
Study site
Taichung
Study site
Taipei
Study site
Taoyuan County
Chile3 sites
Study site
Santiago
Study site
Santiago - Las Condes
Study site
Santiago - Macul
About this study
Official title: 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.
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.
- Conditions
- Psoriasis
- Keywords
- psoriasis, psoriatic arthritis, skin disease, infliximab, ustekinumab, guselkumab, etanercept, adalimumab, secukinumab, ixekizumab, brodalumab, systemic therapy, observational, registry
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 years of follow up for each patient
Secondary outcomes (6)
Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score
Measured: At baseline and every 6 months through up to 8 years
Evaluation of Disease Features: Body surface area
Measured: At baseline and every 6 months through up to 8 years
Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score
Measured: At baseline and every 6 months through up to 8 years
Dermatology Life Quality Index (DLQI) Score
Measured: At baseline and every 6 months through up to 8 years
EuroQOL quality of life assessment
Measured: At baseline and every 6 months through up to 8 years
Hospital Anxiety and Depression Scale (HADS) Score
Measured: At baseline and every 6 months up to Month 18 and then every year up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study start21 Jun 2007
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,167 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508547
- Sponsor's protocol ID
- CR013225
- Other IDs
- C0168Z03
- Acronym
- PSOLAR
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2007
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
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 42602014Ritchlin 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 31799498Kavanaugh 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 30886979Singh 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 30267377Strober 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 26853180Kalb 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
- ClinicalTrials.gov ID
- NCT00508547
- Acronym / sponsor ID
- PSOLAR / CR013225
- Conditions
- Psoriasis
- Keywords
- psoriasis, psoriatic arthritis, skin disease, infliximab, ustekinumab, guselkumab, etanercept, adalimumab
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20,167 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2007 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with psoriasis who meets the inclusion criteria will be eligible to participate in this registry.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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
Evaluation of Disease Features: Body surface area
Time frame: 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
Dermatology Life Quality Index (DLQI) Score
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 42602014Strober 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.
- Derived from this study: PubMed 31799498Ritchlin 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.
- Derived from this study: PubMed 30886979Kavanaugh 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.
- Derived from this study: PubMed 30267377Singh 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.
- Derived from this study: PubMed 26853180Strober 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.
- Derived from this study: PubMed 25970800Kalb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
320 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Janssen Scientific Affairs, LLC at 320 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 320 sites in United States, Canada, Czechia, Japan, Austria and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events and Serious Adverse Events (time frame: Up to 8 years of follow up for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508547, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.