Psoriasis Longitudinal Assessment and Registry (PSOLAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT00508547
First received: July 27, 2007
Last updated: August 7, 2014
Last verified: August 2014

July 27, 2007
August 7, 2014
June 2007
December 2020   (final data collection date for primary outcome measure)
The primary outcomes are to further evaluate the safety of ustekinumab in patients with moderate to severe plaque psoriasis and to further evaluate the safety of infliximab in patients with chronic severe (extensive and/or disabling) plaque psoriasis. [ Time Frame: 8 years from last patient enrolled ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00508547 on ClinicalTrials.gov Archive Site
  • To characterize disease features in patients exposed to ustekinumab and/or infliximab [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • To evaluate clinical outcomes, quality of life, and comorbidities for patients who may receive conventional systemic or biologic therapy for psoriasis [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • To assess the proportion of patients exposed to ustekinumab who meets labeling criteria relative to the number of patients exposed, based on the data collected within the registry [ Time Frame: every 6 months for 8 years ] [ Designated as safety issue: No ]
  • To assess the proportion of patients exposed to infliximab who meets labeling criteria relative to the number of patients exposed, based on the data collected within the registry [ 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 overlapping 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, quality of life, and potential risks for patients who may receive standard therapies for psoriasis.

PSOLAR is an 8-10 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 4000 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
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Non-Probability Sample

Any patients with psoriasis that meets the inclusion and exclusion 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12025
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 and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Ukraine,   Argentina,   Austria,   Belgium,   Canada,   Chile,   Colombia,   Czech Republic,   Greece,   Israel,   Mexico,   Netherlands,   Portugal,   Slovakia,   Slovenia
 
NCT00508547
CR013225, PSOLAR
Yes
Centocor Ortho Biotech Services, L.L.C.
Centocor Ortho Biotech Services, L.L.C.
Not Provided
Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
Centocor Ortho Biotech Services, L.L.C.
August 2014

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