Psoriasis Longitudinal Assessment and Registry (PSOLAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00508547
First received: July 27, 2007
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to further evaluate the safety of infliximab and ustekinumab in patients with plaque psoriasis, and other all forms of psoriasis (such as plaque psoriasis and psoriatic arthritis occurring together). The registry study will track the behavior of the disease in response to other therapies, such as other biologic drugs. The registry will also evaluate clinical outcomes; disease characteristics, including physician reported assessment of psoriatic arthritis (PsA); quality of life, and potential risks for patients who may receive standard therapies for psoriasis.

Condition Intervention Phase
Psoriasis
Arthritis, Psoriatic
Biological: ustekinumab
Biological: Biological therapies other than infliximab and ustekinumab
Drug: conventional systemic agents
Biological: infliximab
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Number of patients with Adverse Events and Serious Adverse Events [ Time Frame: 8 years from last patient enrolled ] [ Designated as safety issue: Yes ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. All adverse events, including those of special interest, such as dysplasias and malignancies of all types, serious infections, and new autoimmune disease, will be documented.


Secondary Outcome Measures:
  • Physician reported plaque psoriasis and psoriatic arthritis (PsA) Score [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index (DLQI) Score [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • EuroQOL quality of life assessment [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: every 6 months up to Month 18 and then every year up to 8 years ] [ Designated as safety issue: No ]
  • Percentage of patients being treated that meets labeling criteria [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Percentage of participants with comorbidities: cardiovascular disease [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Percentage of participants with comorbidities: malignancy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Burden of Disease: Body surface area [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Burden of Disease: Psoriasis Area and Severity Index (PASI) Score [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]

Enrollment: 12052
Study Start Date: June 2007
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
infliximab as prescribed
Biological: infliximab
as prescribed
002
ustekinumab as prescribed
Biological: ustekinumab
as prescribed
003
Biological therapies other than infliximab and ustekinumab as prescribed
Biological: Biological therapies other than infliximab and ustekinumab
as prescribed
004
conventional systemic agents as prescribed
Drug: conventional systemic agents
as prescribed

Detailed Description:
PSOLAR is an 8 year registry study. A registry is an observational study that evaluates the status of a disease. This registry study will only include patients who volunteer to take part. About 2000 infliximab-exposed patients and 4000 ustekinumab-exposed patients as well as a comparable number of patients (4000) on other standard of care psoriasis therapies (e.g. Etanercept) and/or psoriasis treatments (e.g. topical or light therapy treatments) will take part in the registry study, internationally. The Registry does not require any study-specific testing, but may capture test information (e.g. laboratory tests, X-rays) that are collected as part of normal routine care for the registry program. Patient information will be collected at the enrollment visit and about every 6 months thereafter. At enrollment, information on demographics (e.g. gender, race, date of birth), medical history and family medical history, details of past and current psoriasis treatments (e.g. infliximab and standard therapy), and current medication regimens will be collected. Clinical follow-up will be based on observations from physical examination, clinical disease status, Quality of Life assessment (e.g. Dermatology Life Quality Index, Hospital Anxiety and Depression Scale, EQ-5D (EuroQoL-5D is a Quality of Life Questionnaire) Health Questionnaire Scale, Employment/Productivity Health Economic Questionnaire), current medications, and any adverse events/problems reported. During each six -month follow-up visit with the study doctor, information collected will include observations from physical examination, updates on clinical disease status, Quality of life assessments, medications and adverse events/problems. No study agents will be administered in this registry. All patients will receive standard of care treatments prescribed by the patient's physician.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients with psoriasis that meets the inclusion criteria will be eligible to participate in this registry.
Criteria

Inclusion Criteria:

  • Have a diagnosis of psoriasis
  • Are candidates for, or are currently receiving conventional systemic agents (eg, methotrexate, acitretin, cyclosporine or systemic psoralen drug in combination with Ultraviolet A light [PUVA]) or biologic therapy for psoriasis including those with chronic severe (extensive and/or disabling) plaque psoriasis who may be treated with infliximab
  • 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 request for a 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 Centocor-sponsored clinical trial with marketed agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508547

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
Florence, Alabama, United States
Huntsville, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Rogers, Arkansas, United States
United States, California
Bakersfield, California, United States
Beverly Hills, California, United States
Fresno, California, United States
Garden Grove, 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
United States, Colorado
Colorado Springs, Colorado, United States
Englewood, Colorado, United States
United States, Connecticut
Bridgeport, Connecticut, United States
Farmington, Connecticut, United States
United States, Delaware
Newark, Delaware, United States
Wilmington, Delaware, United States
United States, District of Columbia
Washington, District of Columbia, United States
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
United States, Georgia
Alpharetta, Georgia, United States
Atlanta, Georgia, United States
Birmingham, Georgia, United States
Carrollton, Georgia, United States
Conyers, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Rome, Georgia, United States
United States, Idaho
Twin Falls, Idaho, United States
United States, Illinois
Arlington Heights, Illinois, United States
Aurora, Illinois, United States
Champaign, Illinois, United States
Chicago, Illinois, United States
Lincolnshire, Illinois, United States
Maywood, Illinois, United States
Schaumburg, Illinois, United States
Skokie, Illinois, United States
Springfield, Illinois, United States
West Dundee, Illinois, United States
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
United States, Kansas
Topeka, Kansas, United States
United States, Kentucky
Corbin, Kentucky, United States
Lexington, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
Quincy, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Clarkston, Michigan, United States
Clinton Twp, Michigan, United States
Farmington, Michigan, United States
Flint, Michigan, United States
Grand Blanc, Michigan, United States
Grand Rapids, Michigan, United States
Monroe, Michigan, United States
Norton Shores, Michigan, United States
Port Huron, Michigan, United States
Troy, Michigan, United States
Warren, Michigan, United States
United States, Minnesota
Eagan, Minnesota, United States
United States, Missouri
Chesterfield, Missouri, United States
Saint Louis, Missouri, United States
United States, Montana
Helena, Montana, United States
United States, Nevada
Henderson, Nevada, United States
Las Vegas, Nevada, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
Nashua, New Hampshire, United States
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
United States, New York
Auburn, New York, United States
Bronx, New York, United States
Commack, 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
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
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
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Coos Bay, Oregon, United States
Portland, Oregon, United States
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
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
United States, Tennessee
Bartlett, Tennessee, United States
Johnson City, Tennessee, United States
Kingsport, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Arlington, Virginia, United States
Norfolk, Virginia, United States
United States, Washington
Coupeville, Washington, 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
United States, Wisconsin
Appleton, Wisconsin, United States
Pleasant Prairie, Wisconsin, United States
Sheboygan, Wisconsin, United States
Argentina
Buenos Aires N/A, Argentina
Caba, Argentina
Cipoletti, Neuquén, Argentina
Ciudad Autónoma De Buenos Aires, Argentina
Lomas De Zamora, Argentina
San Miguel, Argentina
Austria
Feldkirch N/A, Austria
Klagenfurt, Austria
Laakirchen, Austria
St Poelten, Austria
Wien, Austria
Belgium
Brugge, Belgium
Bruxelles, Belgium
Edegem, Belgium
Gent, Belgium
Liege, Belgium
Mons, Belgium
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, British Columbia
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Moncton, New Brunswick, Canada
Canada, Newfoundland and Labrador
St. John'S, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Kentville, Nova Scotia, Canada
Canada, Ontario
Barrie, Ontario, Canada
Halifax, Ontario, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Markham, Ontario, Canada
Niagra Falls, Ontario, Canada
North Bay, Ontario, Canada
Ottawa, Ontario, Canada
Sudbury, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Canada, Quebec
Laval, Quebec, Canada
Sainte-Foy, Quebec, Canada
Canada
Drummondville, Canada
Montreal, Canada
Nanaimo, Canada
Peterborough, Canada
Quebec, Canada
Surrey, Canada
Chile
Santiago, Chile
Santiago - Las Condes, Chile
Santiago - Macul, Chile
Colombia
Bogota, Colombia
Medellin, Colombia
Czech Republic
Brno, Czech Republic
Ceske Budejovice, Czech Republic
Jihlava N/A, Czech Republic
Olomouc, Czech Republic
Prague, Czech Republic
Praha, Czech Republic
Ústí Nad Labem, Czech Republic
Greece
Athens, Greece
Heraklion, Greece
Ioannina, Greece
Larisa, Greece
Thessaloniki, Greece
Israel
Afula, Israel
Beer Sheva, Israel
Haifa, Israel
Netivot, Israel
Tel Aviv, Israel
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
Slovakia
Banska Bystrica, Slovakia
Bratislava, Slovakia
Kosice, Slovakia
Martin, Slovakia
Poprad, Slovakia
Presov, Slovakia
Trnava, Slovakia
Slovenia
Celje, Slovenia
Izola, Slovenia
Kranj, Slovenia
Ljubljana, Slovenia
Maribor, Slovenia
Ukraine
Dnepropetrovsk, Ukraine
Donetsk, Ukraine
Kharkov, Ukraine
Khmelnitskiy, Ukraine
Kiev, Ukraine
Lugansk, Ukraine
Simferopol, Ukraine
Uzhgorod, Ukraine
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00508547     History of Changes
Other Study ID Numbers: CR013225  PSOLAR 
Study First Received: July 27, 2007
Last Updated: June 6, 2016
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Janssen Scientific Affairs, LLC:
Methotrexate
Acitretin
Cyclosporine
Systemic PUVA
Infliximab
Adalimumab
Alefacept
Efalizumab
Etanercept
Psoriasis
Psoriatic arthritis
Skin disease
Cosentyx

Additional relevant MeSH terms:
Arthritis
Psoriasis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Infliximab
Ustekinumab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 28, 2016