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| ID | Type | Description | Link |
|---|---|---|---|
| C0168Z03 | Other Identifier | Janssen Research & Development, LLC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 8 years of follow up for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score | At baseline and every 6 months through up to 8 years | |
| Evaluation of Disease Features: Body surface area | At baseline and every 6 months through up to 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient with psoriasis who meets the inclusion criteria will be eligible to participate in this registry.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31799498 | Derived | 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. | |
| 30886979 |
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| Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score | At baseline and every 6 months through up to 8 years |
| Dermatology Life Quality Index (DLQI) Score | At baseline and every 6 months through up to 8 years |
| EuroQOL quality of life assessment | At baseline and every 6 months through up to 8 years |
| Hospital Anxiety and Depression Scale (HADS) Score | At baseline and every 6 months up to Month 18 and then every year up to 8 years |
| 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 |
| 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 |
| Auburn | 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 |
| The Bronx | New York | United States |
| White Plains | New York | United States |
| Williamsville | New York | United States |
| Chapel Hill | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Rocky Mount | North Carolina | United States |
| Wilmington | North Carolina | United States |
| 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 City | Oklahoma | United States |
| Coos Bay | Oregon | United States |
| Portland | Oregon | United States |
| Exton | Pennsylvania | United States |
| Fort Washington | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Plymouth Meeting | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Fort Mill | South Carolina | United States |
| Piedmont | South Carolina | United States |
| Spartanburg | South Carolina | United States |
| Bartlett | Tennessee | United States |
| Bristol | Tennessee | United States |
| Kingsport | Tennessee | United States |
| Arlington | Texas | United States |
| Cedar Hill | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Longview | Texas | United States |
| Salt Lake City | Utah | United States |
| Arlington | Virginia | United States |
| Norfolk | Virginia | United States |
| 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 |
| Green Bay | Wisconsin | United States |
| Pleasant Prairie | Wisconsin | United States |
| Sheboygan | Wisconsin | United States |
| Buenos Aires | Argentina |
| CABA | Argentina |
| Cipolletti | Argentina |
| Lomas de Zamora | Argentina |
| San Miguel | Argentina |
| Fremantle | Australia |
| Melbourne | Australia |
| Miranda | Australia |
| Sydney | Australia |
| Woolloongabba | Australia |
| Althofen | Austria |
| Feldkirch | Austria |
| Graz | Austria |
| Klagenfurt | Austria |
| Laakirchen | Austria |
| Sankt Pölten | Austria |
| Vienna | Austria |
| Villach | Austria |
| Bruges | Belgium |
| Brussels | Belgium |
| Edegem | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Mons | Belgium |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Nanaimo | British Columbia | Canada |
| Surrey | British Columbia | Canada |
| Vancouver | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Fredericton | New Brunswick | Canada |
| Moncton | New Brunswick | Canada |
| St. John's | Newfoundland and Labrador | Canada |
| Halifax | Nova Scotia | Canada |
| Kentville | Nova Scotia | Canada |
| Barrie | Ontario | Canada |
| Coburg | Ontario | Canada |
| Greater Sudbury | 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 |
| Saint Catherines | Ontario | Canada |
| Toronto | Ontario | Canada |
| Windsor | Ontario | Canada |
| Drummondville | Quebec | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| Santiago | Chile |
| Santiago - Las Condes | Chile |
| Santiago - Macul | Chile |
| Bogotá | Colombia |
| Medellín | Colombia |
| Brno | Czechia |
| České Budějovice | Czechia |
| Jihlava | Czechia |
| Náchod | Czechia |
| Nový Jičín | Czechia |
| Olomouc | Czechia |
| Pardubice | Czechia |
| Pilsen | Czechia |
| Prague | Czechia |
| Šumperk | Czechia |
| Ústí nad Labem | Czechia |
| Athens | Greece |
| Heraklion | Greece |
| Ioannina | Greece |
| Larissa | Greece |
| Pátrai | Greece |
| Piraeus-Athens | Greece |
| Psychikó | Greece |
| Thessaloniki | Greece |
| Afula | Israel |
| Beersheba | Israel |
| Haifa | Israel |
| Netivot | Israel |
| Petah Tikva | Israel |
| Ramat Gan | Israel |
| Tel Aviv | Israel |
| Hirakata | Japan |
| Hokkaido | Japan |
| Itabashi Ku | Japan |
| Kobe | Japan |
| Kurume | Japan |
| Matsumoto | Japan |
| Ōita | Japan |
| Takamatsu | Japan |
| Tokyo | Japan |
| Tsu | Japan |
| Yokosuka | Japan |
| Estado de México | Mexico |
| Mexico City | Mexico |
| Monterrey | Mexico |
| Zapopan | Mexico |
| Alkmaar | Netherlands |
| Amsterdam-Zuidoost | Netherlands |
| Breda | Netherlands |
| Deventer | Netherlands |
| Helmond | Netherlands |
| Nijmegen | Netherlands |
| Braga | Portugal |
| Lisbon | Portugal |
| Porto | Portugal |
| Vila Nova de Gaia | Portugal |
| Banská Bystrica | Slovakia |
| Bratislava | Slovakia |
| Košice | Slovakia |
| Martin | Slovakia |
| Nitra | Slovakia |
| Poprad | Slovakia |
| Prešov | Slovakia |
| Trnava | Slovakia |
| Celje | Slovenia |
| Izola | Slovenia |
| Kranj | Slovenia |
| Ljubljana | Slovenia |
| Maribor | Slovenia |
| Busan | South Korea |
| Gyeonggi-do | South Korea |
| Seongnam-si | South Korea |
| Seoul | South Korea |
| Sungnam | South Korea |
| Alcalá de Henares | Spain |
| Bilbao | Spain |
| Granada | Spain |
| Madrid | Spain |
| Majadahonda | Spain |
| Murcia | Spain |
| Salamanca | Spain |
| Santiago de Compostela | Spain |
| Eskilstuna | Sweden |
| Gothenburg | Sweden |
| Kungsbacka | Sweden |
| Stockholm | Sweden |
| Kaohsiung City | Taiwan |
| Taichung | Taiwan |
| Taipei | Taiwan |
| Taoyuan County | Taiwan |
| Dnipro | Ukraine |
| Donetsk | Ukraine |
| Kharkiv | Ukraine |
| Khmelnitskiy | Ukraine |
| Kiev | Ukraine |
| Luhansk | Ukraine |
| Simferopol | Ukraine |
| Uzhhorod | Ukraine |
| 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. |
| 30267377 | Derived | 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. |
| 26853180 | Derived | 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. |
| 25970800 | Derived | 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. |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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