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

July 27, 2007
June 6, 2016
June 2007
December 2020   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00508547 on ClinicalTrials.gov Archive Site
  • 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 ]
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Psoriasis Longitudinal Assessment and Registry (PSOLAR)
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 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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Any patients with psoriasis that meets the inclusion criteria will be eligible to participate in this registry.
  • Psoriasis
  • Arthritis, Psoriatic
  • Biological: ustekinumab
    as prescribed
  • Biological: Biological therapies other than infliximab and ustekinumab
    as prescribed
  • Drug: conventional systemic agents
    as prescribed
  • Biological: infliximab
    as prescribed
  • 001
    infliximab as prescribed
    Intervention: Biological: infliximab
  • 002
    ustekinumab as prescribed
    Intervention: Biological: ustekinumab
  • 003
    Biological therapies other than infliximab and ustekinumab as prescribed
    Intervention: Biological: Biological therapies other than infliximab and ustekinumab
  • 004
    conventional systemic agents as prescribed
    Intervention: Drug: conventional systemic agents
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12052
May 2021
December 2020   (final data collection date for primary outcome measure)

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
Both
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Austria,   Belgium,   Canada,   Chile,   Colombia,   Czech Republic,   Greece,   Israel,   Mexico,   Netherlands,   Portugal,   Slovakia,   Slovenia,   Ukraine
Brazil
 
NCT00508547
CR013225, PSOLAR
No
Not Provided
Not Provided
Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
Not Provided
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP