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| Sponsor: | Centocor Ortho Biotech Services, L.L.C. |
|---|---|
| Information provided by: | Centocor Ortho Biotech Services, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00508547 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Psoriasis Arthritis, Psoriatic |
Biological: infliximab Biological: ustekinumab Biological: Biological therapies other than infliximab and ustekinumab Drug: conventional systemic agents |
| Study Type: | Observational |
| Study Design: | 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 |
| Estimated Enrollment: | 12000 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | January 2021 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
001
infliximab as prescribed
|
Biological: infliximab
as prescribed
|
|
002
ustekinumab as prescribed
|
Biological: ustekinumab
as prescribed
|
|
003
Biological therapies other than infliximab and ustekinumab as prescribed
|
Biological: Biological therapies other than infliximab and ustekinumab
as prescribed
|
|
004
conventional systemic agents as prescribed
|
Drug: conventional systemic agents
as prescribed
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Any patients with psoriasis that meets the inclusion and exclusion criteria will be eligible to participate in this registry.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 237 Study Locations| Study Director: | Centocor Ortho Biotech Services, L.L.C. Clinical Trial | Centocor Ortho Biotech Services, L.L.C. |
More Information
| Responsible Party: | SENIOR DIRECTOR, CLINICAL RESEARCH MEDICAL AFFAIRS, Centocor |
| ClinicalTrials.gov Identifier: | NCT00508547 History of Changes |
| Other Study ID Numbers: | CR013225, PSOLAR |
| Study First Received: | July 27, 2007 |
| Last Updated: | July 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Methotrexate Acitretin Cyclosporine Systemic PUVA Infliximab Adalimumab |
Alefacept Efalizumab Etanercept Psoriasis Psoriatic arthritis Skin disease |
|
Arthritis Arthritis, Psoriatic Psoriasis Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Skin Diseases, Papulosquamous |
Skin Diseases Infliximab Antibodies, Monoclonal Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs |