Psoriasis Longitudinal Assessment and Registry (PSOLAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00508547
Recruitment Status : Active, not recruiting
First Posted : July 30, 2007
Last Update Posted : February 5, 2018
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Brief Summary:
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 or disease Intervention/treatment
Psoriasis Arthritis, Psoriatic Biological: ustekinumab Biological: Biological therapies other than infliximab and ustekinumab Drug: conventional systemic agents Biological: infliximab

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.

Study Type : Observational
Actual Enrollment : 12052 participants
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
Actual Study Start Date : June 21, 2007
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
infliximab as prescribed
Biological: infliximab
as prescribed

ustekinumab as prescribed
Biological: ustekinumab
as prescribed

Biological therapies other than infliximab and ustekinumab as prescribed
Biological: Biological therapies other than infliximab and ustekinumab
as prescribed

conventional systemic agents as prescribed
Drug: conventional systemic agents
as prescribed

Primary Outcome Measures :
  1. Number of patients with Adverse Events and Serious Adverse Events [ Time Frame: 8 years from last patient enrolled ]
    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 :
  1. Physician reported plaque psoriasis and psoriatic arthritis (PsA) Score [ Time Frame: every 6 months for 8 years ]
  2. Dermatology Life Quality Index (DLQI) Score [ Time Frame: every 6 months for 8 years ]
  3. EuroQOL quality of life assessment [ Time Frame: every 6 months for 8 years ]
  4. Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: every 6 months up to Month 18 and then every year up to 8 years ]
  5. Percentage of patients being treated that meets labeling criteria [ Time Frame: every 6 months for 8 years ]
  6. Percentage of participants with comorbidities: cardiovascular disease [ Time Frame: Day 1 ]
  7. Percentage of participants with comorbidities: malignancy [ Time Frame: Day 1 ]
  8. Burden of Disease: Body surface area [ Time Frame: every 6 months for 8 years ]
  9. Burden of Disease: Psoriasis Area and Severity Index (PASI) Score [ Time Frame: every 6 months for 8 years ]
  10. Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score [ Time Frame: every 6 months for 8 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00508547

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Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Janssen Scientific Affairs, LLC Identifier: NCT00508547     History of Changes
Other Study ID Numbers: CR013225
PSOLAR ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Scientific Affairs, LLC:
Systemic PUVA
Psoriatic arthritis
Skin disease

Additional relevant MeSH terms:
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spinal Diseases
Bone Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents