Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 110
- 主要终点
- Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI
研究概览
简要总结
The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care
- •At least one of the following forms of psoriatic arthritis (PsA):
- •Distal interphalangeal (DIP) involvement (inflammatory)
- •Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
- •Arthritis mutilans
- •Asymmetric peripheral arthritis or
- •Spinal involvement
- •Active psoriatic arthritis at the time of the study enrollment
- •Patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints
- •Greater than 18 years of age at the time of consent
- •Able to start etanercept therapy per the approved product monograph
- •Informed consent must be provided before any study specific procedures are performed
排除标准
- •Active infections at time of initiating Enbrel® therapy
- •Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication
- •A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years
- •Known hypersensitivity to etanercept or any of its components
- •Patients receiving, or who have received:
- •Remicade® (infliximab) in the previous 3 months or -- Humira® (adalimumab) in the previous 3 months or
- •Kineret® (anakinra) in the previous 15 days
- •Patients receiving or who have received etanercept
- •Treatment with any investigational therapy in the 30 days prior to enrollment or during the study
- •Active guttate, erythrodermic or pustular psoriasis at the time of screening
- •Presence of any significant and uncontrolled medical condition, which in the Investigator's opinion, precludes the use of etanercept as outlined in the product monograph
- •Sepsis or at risk of septic syndrome
- •Patients not available for follow-up assessment
- •Concerns for subject's compliance with the protocol procedures
研究组 & 干预措施
Etanercept
Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
干预措施: Etanercept (Drug)
结局指标
主要结局
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI
时间窗: Baseline and 24 months
The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
次要结局
- Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module(Baseline and 24 months)
- Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module(Baseline and Month 24)
- Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module(Baseline and month 24)
- Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module(Baseline and month 24)
- Change From Baseline to Month 24 in the Physician Global Assessment(Baseline and month 24)
- Percent Change From Baseline to Month 24 in Physician Global Assessment(Baseline and Month 24)
- Change From Baseline to Month 24 in Patient Global Assessment(Baseline and Month 24)
- Percent Change From Baseline to Month 24 in Patient Global Assessment(Baseline and month 24)
- Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)(Baseline and Month 24)
- Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24(Baseline and Month 24)