Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,314
- 试验地点
- 282
- 主要终点
- The Start and Stop Date of Guselkumab, as Applicable, For Each Participant
研究概览
简要总结
The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).
详细描述
Psoriatic arthritis (PsA) is a seronegative inflammatory spondylarthritis associated with psoriasis (PsO), which can cause pain and swelling in the joints, sausage-shaped swelling of the fingers and toes (dactylitis), inflammation of the muscle- or tendon insertions at adjacent bone (enthesitis), as well as raised red patches or various other expressions of psoriasis on the skin. Guselkumab (TREMFYA) is a fully human immunoglobulin G1 lambda (IgG1) monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL) 23 with high specificity and affinity, blocking IL-23 binding. Binding of guselkumab to the IL-23p19 subunit blocks the subsequent binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling and subsequent activation and cytokine production. Participants with confirmed diagnosis of PsA who are starting guselkumab or any marketed interleukin-17 inhibitor (IL-17i) as a first, second, third, or fourth line of PsA biologic therapy per standard clinical practice will be enrolled in the main study. The aim of main study is to document the use of guselkumab and approved IL-17i therapies in routine clinical practice in patients with PsA who are starting guselkumab or an IL-17i as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy. The overall duration of the main study, including recruitment and follow-up, is expected to be about 6 years. Participants who are starting guselkumab or an IL-17i treatment per routine clinical practice in the main study, and who meet the selection criteria for both the main study and substudy, will be consecutively offered entry into the substudy (a select number) at the time of enrollment into the main study. The substudy aims to collect additional data, continuously or with increased frequency, on the impact of guselkumab or IL-17i on patient mood, physical activity, sleep disturbance, disease symptoms, and health-related quality-of-life (HRQoL). Total duration of the substudy will be approximately 26-30 weeks consisting of a pre-treatment period of up to 14 days before the first dose of guselkumab or IL-17i in the main study and a 24-week (plus [+] up to 4 weeks follow-up) observation period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main study:
- •Have a confirmed diagnosis of PsA as determined by a rheumatologist with reference to Classification criteria for Psoriatic Arthritis (CASPAR)
- •Start guselkumab or any approved interleukin-17 inhibitor (IL-17i) as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy for the indication of PsA as part of standard clinical practice (according to local label, local regulations, and/or reimbursement requirements) at the time of enrollment into the observational study or within a maximum of 2 months after the initial baseline visit or after repeated baseline data collection
- •Sign a participation agreement/Informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
- •Able to read, understand, and intend to comply with completion of all Electronic patient-reported outcome (ePRO) instruments
- •The treatment decision must be taken by the participating rheumatologist prior to, and independently of the participant's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations
- •Must sign the substudy ICF allowing data collection in accordance with local requirements
- •Is scheduled to receive guselkumab or IL-17i, per routine clinical practice, in the main study
- •Currently using or is willing to use wearables and/or commercial applications to track their disease within the course of their normal daily activities
排除标准
- •Main study:
- •Start guselkumab or an IL-17i therapy as fifth or further line of biologic treatment
- •Have already taken a specific IL-17i or IL-23i treatment and are planning on re-taking that specific treatment again
- •Unwilling or unable to participate in long-term data collection
- •Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study (that is, signing of informed consent)
- •Currently enrolled in any interventional study or any Janssen-sponsored observational clinical study (contemporary participation into observational studies or registries not sponsored by Janssen is acceptable)
- •Have an insufficient command of language to interact effectively with the smartphone application, in the opinion of the investigator at each site
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (example, compromise the well-being) or that could prevent, limit, or confound assessment
- •Unwilling or unable to comply with substudy assessments
研究组 & 干预措施
Cohort 1: Guselkumab
Data as available from participant's source medical records will be collected for adult participants with a confirmed diagnosis of Psoriatic Arthritis (PsA) who are starting guselkumab as a first, second, third, or fourth line of PsA biologic therapy either as monotherapy or with other medications per routine clinical practice in main study. Participants who meet the selection criteria for both the main study and substudy, will be consecutively offered to be enrolled into the substudy at the time of enrollment into the main study.
干预措施: Guselkumab (Drug)
Cohort 2: Interleukin-17 inhibitor (IL-17i)
Data as available from participant's source medical records will be collected for adult participants with a confirmed diagnosis of PsA who are starting IL-17i as a first, second, third, or fourth line of PsA biologic therapy either as monotherapy or with other medications per routine clinical practice in main study. Participants who meet the selection criteria for both the main study and substudy, will be consecutively offered to be enrolled into the substudy at the time of enrollment into the main study.
干预措施: IL-17i (Drug)
结局指标
主要结局
The Start and Stop Date of Guselkumab, as Applicable, For Each Participant
时间窗: Up to 39 months
The start and stop date, (first and last administration date, respectively) of guselkumab, as applicable, for each participant will be collected to document treatment persistence.
The Start and Stop Date of Interleukin-17 Inhibitor (IL-17i), as Applicable, For Each Participant
时间窗: Up to 39 months
The start and stop date (first and last administration date respectively) of IL-17i, as applicable, for each participant will be collected to document treatment persistence.
次要结局
- Change from Baseline in 66 and 68 Joint Counts for Swelling and Tenderness, Respectively(Baseline up to 39 months)
- Change from Baseline in Assessment of Dactylitis(Baseline up to 39 months)
- Change from Baseline in Rheumatologist's Global Assessment of Disease Activity-Psoriatic Arthritis (PGA-PsA)(Baseline up to 39 months)
- Change from Baseline in Assessment of Enthesitis using Leeds Enthesitis Index (LEI)(Baseline up to 39 months)
- Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12)(Baseline up to 39 months)
- Change from Baseline in Patient Global Disease Activity Visual Analog Scale (VAS) Scores(Baseline up to 39 months)
- Change from Baseline in Pain VAS Score(Baseline up to 39 months)
- Change from Baseline in Dermatology Life Quality Index (DLQI)(Baseline up to 39 months)
- Change from Baseline in Patient Acceptable Symptom State (PASS)(Baseline up to 39 months)
- Change from Baseline in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA/DAPSA)(Baseline up to 39 months)
- Response as a Measure of Clinical Improvement in cDAPSA/DAPSA(Up to 39 months)
- Start and Stop Dates of All Treatments and the Sequence of Treatment Lines(Up to 39 months)
- Rheumatic Disease Comorbidity Index(Up to 39 months)
- Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriatic Arthritis (WPAI: PsA)(Baseline up to 39 months)
- Number of Participants Switching or Stopping Treatment(Up to 39 months)
- Change from Baseline in Nail Involvement(Baseline up to 39 months)
- Change from Baseline in Body Surface Area (BSA) Psoriasis (PSO) Skin Involvement(Baseline up to 39 months)
- Change from Baseline in Minimal Disease Activity (MDA)/ Very Low Disease Activity (VLDA)(Baseline up to 39 months)
- Percentage of Participants with Adverse Events (AEs)(Up to 39 months)
- BSA PSO Skin Involvement(Up to 39 months)
- Change from Baseline in Fibromyalgia Rapid Screening Tool (FiRST)(Baseline up to 6 months)
- Change from Baseline in C-reactive Protein (CRP)(Baseline up to 39 months)
- Change from Baseline in European Quality of Life (EuroQoL) 5-Dimensions 5-Levels Questionnaire (EQ-5D-5L)(Baseline up to 39 months)
- Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline up to 39 months)
- Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline up to 39 months)
- Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP)(Baseline up to 39 months)
- Change from Baseline in Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)(Baseline up to 39 months)