Psoriasis Longitudinal Assessment and Registry

Psoriasis Clinical Trial

— PSOLAR  

Official title:

A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00508547
• Other study ID #: CR013225
• Secondary ID: PSOLAR
• Status: Active, not recruiting
• Start date: June 21, 2007
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2024
• Source: Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 15842
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Chile,  Colombia,  Czechia,  Greece,  Israel,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Portugal,  Slovakia,  Slovenia,  Spain,  Sweden,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events and Serious Adverse Events	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.	Up to 8 years of follow up for each patient
Secondary	Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score		At baseline and every 6 months through up to 8 years
Secondary	Evaluation of Disease Features: Body surface area		At baseline and every 6 months through up to 8 years
Secondary	Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score		At baseline and every 6 months through up to 8 years
Secondary	Dermatology Life Quality Index (DLQI) Score		At baseline and every 6 months through up to 8 years
Secondary	EuroQOL quality of life assessment		At baseline and every 6 months through up to 8 years
Secondary	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