Psorcast Mobile Study
NCT05621369
Arthralgia, Arthritis
Seattle, Washington, United States
View Trial DetailsNCT Number: NCT00508547
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.
This study is active but is not currently recruiting participants.
18 year–99 year
All sexes
Observational
Buenos Aires, Argentina
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: At baseline and every 6 months through up to 8 years
Time frame: At baseline and every 6 months through up to 8 years
Time frame: At baseline and every 6 months through up to 8 years
Time frame: At baseline and every 6 months through up to 8 years
Time frame: At baseline and every 6 months through up to 8 years
Time frame: At baseline and every 6 months up to Month 18 and then every year up to 8 years
Janssen Scientific Affairs, LLC
Industry
A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
Acronym: PSOLAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05621369
Arthralgia, Arthritis
Seattle, Washington, United States
View Trial DetailsNCT01706692
Arthritis, Arthritis, Psoriatic
Aarau, Switzerland
View Trial DetailsNCT05908240
Arthritis, Arthritis, Psoriatic
Scottsdale, Arizona, United States
View Trial DetailsNCT05866614
Ankylosing Spondylitis, Ankylosis
Toulouse, France
View Trial Details