Psoriasis Longitudinal Assessment and Registry (PSOLAR)
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 3/27/2019 |
Start Date: | June 21, 2007 |
End Date: | December 1, 2029 |
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: |
Email: | JNJ.CT@sylogent.com |
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, ustekinumab, and
guselkumab 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.
guselkumab 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.
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 4000 infliximab-exposed patients, 4000 ustekinumab-exposed patients and 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. Additionally, enrollment will be opened to
include at least 2,000 guselkumab-exposed patients and up to 2,000 patients exposed to IL-17
inhibitors (example, secukinumab, ixekizumab, brodalumab). 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.
status of a disease. This registry study will only include patients who volunteer to take
part. About 4000 infliximab-exposed patients, 4000 ustekinumab-exposed patients and 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. Additionally, enrollment will be opened to
include at least 2,000 guselkumab-exposed patients and up to 2,000 patients exposed to IL-17
inhibitors (example, secukinumab, ixekizumab, brodalumab). 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.
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 or those with moderate to severe plaque psoriasis who may be treated with
ustekinumab, guselkumab, or another biologic agent
- 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
We found this trial at
224
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of Utah Research is a major component in the life of the U benefiting...
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Indiana University Medical Center Indiana University Health is Indiana
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