Psoriasis
Conditions
Keywords
psoriasis, psoriatic arthritis, skin disease, infliximab, ustekinumab, guselkumab, etanercept, adalimumab, secukinumab, ixekizumab, brodalumab, systemic therapy, observational, registry
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.
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.
Interventions
None listed
Sponsors
Janssen Scientific Affairs, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events and Serious Adverse Events | Up to 8 years of follow up for each patient | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score | At baseline and every 6 months through up to 8 years |
| Evaluation of Disease Features: Body surface area | At baseline and every 6 months through up to 8 years |
| Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score | At baseline and every 6 months through up to 8 years |
| Dermatology Life Quality Index (DLQI) Score | At baseline and every 6 months through up to 8 years |
| EuroQOL quality of life assessment | At baseline and every 6 months through up to 8 years |
| Hospital Anxiety and Depression Scale (HADS) Score | At baseline and every 6 months up to Month 18 and then every year up to 8 years |
Countries
Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czechia, Greece, Israel, Japan, Mexico, Netherlands, Portugal, Slovakia, Slovenia, South Korea, Spain, Sweden, Taiwan, Ukraine, United States
Contacts
STUDY_DIRECTORJanssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Outcome results
None listed