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Psoriasis Longitudinal Assessment and Registry (PSOLAR)
This study is currently recruiting participants.
Verified by Centocor, Inc., December 2008
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00508547
  Purpose

The purpose of this study is to evaluate the safety of infliximab in patients with chronic severe plaque psoriasis as well as the clinical outcomes, quality of life and comorbidities for patients who receive conventional systemic or biologic therapy for plaque psoriasis.


Condition Phase
Psoriasis
Arthritis, Psoriatic
Phase IV

MedlinePlus related topics: Psoriasis
Drug Information available for: Methotrexate Cyclosporin Cyclosporine Adalimumab Etanercept Efalizumab Infliximab Alefacept Acitretin
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics

Further study details as provided by Centocor, Inc.:

Estimated Enrollment: 8000
Study Start Date: June 2007
Detailed Description:

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 subjects who volunteer to take part. About 4000 infliximab-exposed subjects and 4000 additional patients receiving other Psoriasis medications/treatments (e.g. Etanercept, steroids, etc.) will take part in the registry study at about 450 centers in the U.S. 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. Upon enrollment, the following information will be collected: demographics (e.g. gender, race, date of birth), medical history, family medical history, history of previous psoriasis treatments, current medications, how you receive infliximab or standard therapies and clinical follow-up, observations from your physical examinations, clinical disease status, Quality of life assessment (e.g. Dermatology Life Quality Index, Hospital Anxiety and Depression Scale, EQ-5D Health Questionnaire Scale, Employment/Productivity Health Economic Questionnaire), current medications, and any adverse events/problems. 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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of psoriasis
  • Are candidates for or are currently receiving conventional systemic agents (eg, MTX, acitretin, cyclosporine or systemic 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508547

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

  Show 90 Study Locations
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

Study ID Numbers: CR013225
Study First Received: July 27, 2007
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00508547  
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor, Inc.:
Infliximab
Adalimumab
psoriatic arthritis
Cyclosporine
psoriasis
Etanercept
Acitretin
Methotrexate
Efalizumab
Systemic PUVA
skin disease
Alefacept

Study placed in the following topic categories:
Spinal Diseases
Alefacept
Cyclosporine
Skin Diseases
Infliximab
Arthritis, Psoriatic
Joint Diseases
Spondylarthropathy
Adalimumab
Cyclosporins
Bone Diseases
Musculoskeletal Diseases
Psoriasis
Arthritis
Methotrexate
Acitretin
Spondylarthritis
Skin Diseases, Papulosquamous
Spondylarthropathies

ClinicalTrials.gov processed this record on January 16, 2009