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Active (not recruiting) NCT00508547

Psoriasis Longitudinal Assessment and Registry

Conditions: Psoriasis

Sponsor: Janssen Scientific Affairs, LLC

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Locations 20
Argentina (1)
Buenos Aires
Australia (1)
Fremantle
Belgium (1)
Bruges
Canada (1)
Calgary , Alberta
Chile (1)
Santiago
Colombia (1)
Bogotá
Czech Republic (1)
Brno
Greece (1)
Athens
Israel (1)
Afula
Japan (1)
Hirakata
Mexico (1)
Estado de México
Netherlands (1)
Alkmaar
Portugal (1)
Braga
Slovakia (1)
Banská Bystrica
South Korea (1)
Busan
Spain (1)
Alcalá de Henares
Sweden (1)
Eskilstuna
Taiwan (1)
Kaohsiung City
Ukraine (1)
Dnipro
United States (1)
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
21.06.2007
Completion date
31.12.2030
Registry ID
NCT00508547
Source
anzctr
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