![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Centocor, Inc. |
---|---|
Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00508547 |
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.
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 |
Estimated Enrollment: | 8000 |
Study Start Date: | June 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
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 |
Infliximab Adalimumab psoriatic arthritis Cyclosporine psoriasis Etanercept |
Acitretin Methotrexate Efalizumab Systemic PUVA skin disease Alefacept |
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 |