Psoriasis Longitudinal Assessment and Registry
- Conditions
- Psoriasis
- Registration Number
- NCT00508547
- Lead Sponsor
- Janssen Scientific Affairs, LLC
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15842
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method EuroQOL quality of life assessment At baseline and every 6 months through up to 8 years 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 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