A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20,167
- 试验地点
- 315
- 主要终点
- Adverse Events and Serious Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Biological Therapies
Participants will receive biological therapies other than infliximab, ustekinumab, guselkumab, and IL-17 inhibitors as prescribed by a physician for psoriasis. Participants will not receive any intervention as a part of this study.
Ustekinumab
Participants will receive ustekinumab as prescribed by a physician according to standard of care for psoriasis.
Conventional Systemic Agents
Participants will receive conventional systemic agents as prescribed by a physician for psoriasis. Participants will not receive any intervention as a part of this study.
IL-17 Inhibitor
Participants will receive an IL-17 inhibitor as prescribed by a physician according to standard of care for psoriasis.
Guselkumab
Participants will receive guselkumab as prescribed by a physician according to standard of care for psoriasis.
Infliximab
Participants will receive infliximab as prescribed by a physician according to standard of care for psoriasis.
结局指标
主要结局
Adverse Events and Serious Adverse Events
时间窗: 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.
次要结局
- 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)
- EuroQOL quality of life assessment(At baseline and every 6 months through up to 8 years)