Clinical trial NCT00508547: Psoriasis Longitudinal Assessment and Registry
Official title: A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Keywords: psoriasis
psoriatic arthritis
skin disease
infliximab
ustekinumab
guselkumab
etanercept
adalimumab
secukinumab
ixekizumab
brodalumab
systemic therapy
observational
registry
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2007-07-30
Enrollment: 15842
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with psoriasis who meets the inclusion criteria will be eligible to participate in this registry.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: Up to 8 years of follow up for each patient
Secondary outcomes:
measure: Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score
timeFrame: At baseline and every 6 months through up to 8 years
measure: Evaluation of Disease Features: Body surface area
timeFrame: At baseline and every 6 months through up to 8 years
measure: Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score
timeFrame: At baseline and every 6 months through up to 8 years
measure: Dermatology Life Quality Index (DLQI) Score
timeFrame: At baseline and every 6 months through up to 8 years
measure: EuroQOL quality of life assessment
timeFrame: At baseline and every 6 months through up to 8 years
measure: Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: At baseline and every 6 months up to Month 18 and then every year up to 8 years
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Florence
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Rogers
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Clovis
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Fresno
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Redding
country: United States
state: California
city: Rolling Hills Estates
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Ramon
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Sherman Oaks
country: United States
state: California
city: Upland
country: United States
state: California
city: Vallejo
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Farmington
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Wilmington
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Aventura
country: United States
state: Florida
city: Bay Pines
country: United States
state: Florida
city: Boca Raton
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Dunedin
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Seminole
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Birmingham
country: United States
state: Georgia
city: Carrollton
country: United States
state: Georgia
city: Conyers
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state: Georgia
city: Lilburn
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state: Georgia
city: Macon
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state: Georgia
city: Marietta
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state: Georgia
city: Rome
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state: Georgia
city: Twin Falls
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state: Idaho
city: Champaign
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state: Illinois
city: Chicago
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state: Illinois
city: Lincolnshire
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Rolling Meadows
country: United States
state: Illinois
city: Schaumburg
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state: Illinois
city: Skokie
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state: Illinois
city: Springfield
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state: Illinois
city: West Dundee
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state: Illinois
city: Winfield
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state: Illinois
city: Evansville
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state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: New Albany
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state: Indiana
city: Plainfield
country: United States
state: Indiana
city: West Lafayette
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state: Indiana
city: Topeka
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state: Kansas
city: Corbin
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state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Quincy
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Clarkston
country: United States
state: Michigan
city: Clinton Township
country: United States
state: Michigan
city: Farmington
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
city: Fort Gratiot
country: United States
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city: Grand Blanc
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Monroe
country: United States
state: Michigan
city: Norton Shores
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city: Troy
country: United States
state: Michigan
city: Warren
country: United States
state: Michigan
city: Eagan
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
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state: Montana
city: Henderson
country: United States
state: Nevada
city: Las Vegas
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state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: Nashua
country: United States
state: New Hampshire
city: Belleville
country: United States
state: New Jersey
city: East Windsor
country: United States
state: New Jersey
city: Hoboken
country: United States
state: New Jersey
city: Marlton
country: United States
state: New Jersey
city: Rutherford
country: United States
state: New Jersey
city: Somerset
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state: New Jersey
city: Verona
country: United States
state: New Jersey
city: Wyckoff
country: United States
state: New Jersey
city: Auburn
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Commack
country: United States
state: New York
city: East Syracuse
country: United States
state: New York
city: Elmhurst
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: Huntington
country: United States
state: New York
city: Lawrence
country: United States
state: New York
city: New York
country: United States
state: New York
city: Oceanside
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Smithtown
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Suffern
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: White Plains
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Raleigh
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state: North Carolina
city: Rocky Mount
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
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state: Ohio
city: Columbus
country: United States
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city: Dayton
country: United States
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city: Delaware
country: United States
state: Ohio
city: Gahanna
country: United States
state: Ohio
city: Warren
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state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Coos Bay
country: United States
state: Oregon
city: Portland
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state: Oregon
city: Exton
country: United States
state: Pennsylvania
city: Fort Washington
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Plymouth Meeting
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Fort Mill
country: United States
state: South Carolina
city: Piedmont
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Bartlett
country: United States
state: Tennessee
city: Bristol
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Cedar Hill
country: United States
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city: Houston
country: United States
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city: Longview
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city: Salt Lake City
country: United States
state: Utah
city: Arlington
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Kennewick
country: United States
state: Washington
city: Mount Vernon
country: United States
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city: Seattle
country: United States
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city: Tacoma
country: United States
state: Washington
city: University Place
country: United States
state: Washington
city: Walla Walla
country: United States
state: Washington
city: Green Bay
country: United States
state: Wisconsin
city: Pleasant Prairie
country: United States
state: Wisconsin
city: Sheboygan
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Caba
country: Argentina
city: Cipoletti
country: Argentina
city: Ciudad Autónoma de Buenos Aires
country: Argentina
city: Lomas de Zamora
country: Argentina
city: San Miguel
country: Argentina
city: Fremantle
country: Australia
city: Melbourne
country: Australia
city: Miranda
country: Australia
city: Sydney
country: Australia
city: Woolloongabba
country: Australia
city: Althofen
country: Austria
city: Feldkirch N/a
country: Austria
city: Graz
country: Austria
city: Klagenfurt Am Woerthersee
country: Austria
city: Klagenfurt
country: Austria
city: Laakirchen
country: Austria
city: St Poelten
country: Austria
city: Vienna
country: Austria
city: Villach
country: Austria
city: Wien
country: Austria
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Mons
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Nanaimo
country: Canada
state: British Columbia
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Fredericton
country: Canada
state: New Brunswick
city: Moncton
country: Canada
state: New Brunswick
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Kentville
country: Canada
state: Nova Scotia
city: Barrie
country: Canada
state: Ontario
city: Coburg
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: North Bay
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: St Catherines
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Drummondville
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Santiago - Las Condes
country: Chile
city: Santiago - Macul
country: Chile
city: Santiago
country: Chile
city: Bogota
country: Colombia
city: Medellin
country: Colombia
city: Brno
country: Czechia
city: Ceske Budejovice
country: Czechia
city: Jihlava N/a
country: Czechia
city: Nachod
country: Czechia
city: Novy Jicin
country: Czechia
city: Olomouc
country: Czechia
city: Pardubice
country: Czechia
city: Plzen
country: Czechia
city: Praha 10
country: Czechia
city: Praha 2
country: Czechia
city: Praha 5
country: Czechia
city: Praha 8
country: Czechia
city: Sumperk
country: Czechia
city: Usti nad Labem
country: Czechia
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Ioannina
country: Greece
city: Larisa
country: Greece
city: Patras
country: Greece
city: Piraeus-Athens
country: Greece
city: Thessaloniki
country: Greece
city: Afula
country: Israel
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Netivot
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Tel Aviv
country: Israel
city: Hirakata
country: Japan
city: Hokkaido
country: Japan
city: Itabashi Ku
country: Japan
city: Kobe
country: Japan
city: Kurume
country: Japan
city: Matsumoto
country: Japan
city: Oita
country: Japan
city: Takamatsu
country: Japan
city: Tokyo
country: Japan
city: Tsu
country: Japan
city: Yokosuka
country: Japan
city: Busan
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Seongnam-si
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Sungnam
country: Korea, Republic of
city: Estado de Mexico
country: Mexico
city: Mexico city
country: Mexico
city: Monterrey
country: Mexico
city: Zapopan
country: Mexico
city: Alkmaar
country: Netherlands
city: Amsterdam Zuidoost
country: Netherlands
city: Breda
country: Netherlands
city: Deventer
country: Netherlands
city: Helmond
country: Netherlands
city: Nijmegen
country: Netherlands
city: Braga
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Vila Nova de Gaia
country: Portugal
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Martin
country: Slovakia
city: Nitra
country: Slovakia
city: Poprad
country: Slovakia
city: Presov
country: Slovakia
city: Trnava
country: Slovakia
city: Celje
country: Slovenia
city: Izola
country: Slovenia
city: Kranj
country: Slovenia
city: Ljubljana
country: Slovenia
city: Maribor
country: Slovenia
city: Alcalá de Henares
country: Spain
city: Bilbao
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Majadahonda
country: Spain
city: Murcia
country: Spain
city: Salamanca
country: Spain
city: Santiago de Compostela
country: Spain
city: Eskilstuna
country: Sweden
city: Goteborg
country: Sweden
city: Kungsbacka
country: Sweden
city: Stockholm
country: Sweden
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei-City
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan County
country: Taiwan
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Khmelnitskiy
country: Ukraine
city: Kiev
country: Ukraine
city: Lugansk
country: Ukraine
city: Simferopol
country: Ukraine
city: Uzhgorod
country: Ukraine
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.