Brief Summary
The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and guselkumab in patients with plaque and other forms of psoriasis. The study also includes patients receiving other therapies, such as non-biologic and other biologic agents. The registry also evaluates patient and disease characteristics, including patient-reported assessment of psoriatic arthritis (PsA); and clinical and quality of life outcomes.
Brief Title
Psoriasis Longitudinal Assessment and Registry
Detailed Description
PSOLAR is an ongoing voluntary observational study in which infliximab-exposed patients, ustekinumab-exposed patients, and patients treated with other biologic and non-biologic standard of care therapies have been enrolled internationally and are followed for up to 8 years. Additionally, enrollment is opened to include at least 2000 guselkumab-exposed patients and up to 2000 patients exposed to IL-17 inhibitors. The Registry does not require any study-specific testing, but may capture information collected as part of normal routine care. Patient information is collected at the enrollment visit and about every 6 months thereafter. At enrollment, information on demographics (e.g. gender, and race), medical history and family medical history, details of past and current psoriasis treatments, and current psoriasis medications is collected. At enrollment and each follow-up visit, data are collected regarding physical examination, clinical disease status, Quality of Life assessments, current psoriasis medications, patient-reported PsA assessments, and adverse events. No study agents are administered for the purpose of this registry; all patients receive standard of care treatment as prescribed by the patient's physician.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Psoriasis
Eligibility Criteria
Inclusion Criteria:
* Have a diagnosis of psoriasis
* Incident or prevalent users of Tremfya or an IL-17 inhibitor (eg, secukinumab, ixekizumab, brodalumab, bimekizumab) at the time of their enrollment. Incident users are defined as those participants starting treatment within 30 days before or after the enrollment visit and prevalent users are defined as those who are on treatment greater than 30 days prior to the enrollment visit
* 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 requests for 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 Janssen-sponsored clinical trial with marketed agents
* Have a diagnosis of psoriasis
* Incident or prevalent users of Tremfya or an IL-17 inhibitor (eg, secukinumab, ixekizumab, brodalumab, bimekizumab) at the time of their enrollment. Incident users are defined as those participants starting treatment within 30 days before or after the enrollment visit and prevalent users are defined as those who are on treatment greater than 30 days prior to the enrollment visit
* 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 requests for 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 Janssen-sponsored clinical trial with marketed agents
Inclusion Criteria
Inclusion Criteria:
* Have a diagnosis of psoriasis
* Incident or prevalent users of Tremfya or an IL-17 inhibitor (eg, secukinumab, ixekizumab, brodalumab, bimekizumab) at the time of their enrollment. Incident users are defined as those participants starting treatment within 30 days before or after the enrollment visit and prevalent users are defined as those who are on treatment greater than 30 days prior to the enrollment visit
* Ability to understand and sign an informed consent form
* Are willing to participate in regular follow-up visits
* Have a diagnosis of psoriasis
* Incident or prevalent users of Tremfya or an IL-17 inhibitor (eg, secukinumab, ixekizumab, brodalumab, bimekizumab) at the time of their enrollment. Incident users are defined as those participants starting treatment within 30 days before or after the enrollment visit and prevalent users are defined as those who are on treatment greater than 30 days prior to the enrollment visit
* Ability to understand and sign an informed consent form
* Are willing to participate in regular follow-up visits
Gender
All
Gender Based
false
Keywords
psoriasis
psoriatic arthritis
skin disease
infliximab
ustekinumab
guselkumab
etanercept
adalimumab
secukinumab
ixekizumab
brodalumab
systemic therapy
observational
registry
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT00508547
Org Class
Industry
Org Full Name
Janssen Scientific Affairs, LLC
Org Study Id
CR013225
Overall Status
Active, not recruiting
Official Title
A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
Primary Outcomes
Outcome Description
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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; suspected transmission of any infectious agent via medicinal product; any important medical events. All adverse events, including those of special interest, such as malignancies;TB;opportunistic infections;depression;hypersensitivity reactions; autoimmune disease; neurologic or demyelinating events; congestive heart failure; gastrointestinal events; demyelinating disease, hepatotoxicity; hematologic events; unexpected reaction to a vaccine;cerebrovascular accident; transient ischemic attack; confirmed myocardial infarction; acquired immunodeficiency syndrome will be documented.
Outcome Measure
Adverse Events and Serious Adverse Events
Outcome Time Frame
Up to 8 years of follow up for each patient
Secondary Ids
Secondary Id
C0168Z03
Secondary Outcomes
Outcome Time Frame
At baseline and every 6 months through up to 8 years
Outcome Measure
Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score
Outcome Time Frame
At baseline and every 6 months through up to 8 years
Outcome Measure
Evaluation of Disease Features: Body surface area
Outcome Time Frame
At baseline and every 6 months through up to 8 years
Outcome Measure
Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score
Outcome Time Frame
At baseline and every 6 months through up to 8 years
Outcome Measure
Dermatology Life Quality Index (DLQI) Score
Outcome Time Frame
At baseline and every 6 months through up to 8 years
Outcome Measure
EuroQOL quality of life assessment
Outcome Time Frame
At baseline and every 6 months up to Month 18 and then every year up to 8 years
Outcome Measure
Hospital Anxiety and Depression Scale (HADS) Score
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Any patient with psoriasis who meets the inclusion criteria will be eligible to participate in this registry.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Steven Cohen
Investigator Email
srcohen@montefiore.org
Investigator Phone
917-817-9696