REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)
2014年3月24日 更新者：Amgen
Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®
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.
研究概览
研究类型
介入性
注册 (实际的)
110
阶段
- 第四阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Etanercept
Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
|
Administered according to the product monograph by subcutaneous (SC) injection
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI
大体时间：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.
|
Baseline and 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module
大体时间：Baseline and 24 months
|
The HLQ collects quantitative data on the relation between illness and treatment and work performance.
The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor.
The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems.
Change from Baseline was calculated as the Baseline value - Month 24 value.
A positive change from Baseline value indicates improvement.
|
Baseline and 24 months
|
|
Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module
大体时间：Baseline and Month 24
|
The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. |
Baseline and Month 24
|
|
Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module
大体时间：Baseline and month 24
|
The HLQ collects quantitative data on the relation between illness and treatment and work performance.
The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor.
The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant.
Change from Baseline was calculated as the Baseline value - Month 24 value.
A positive change from Baseline value indicates improvement.
|
Baseline and month 24
|
|
Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module
大体时间：Baseline and month 24
|
In the HLQ impediments to paid and unpaid labor module participants were asked "Were you hindered by health problems at your paid work over the past two weeks?" and answered according to the following: 'no not at all = 0', 'yes, a little = 1', 'yes, very = 2'.
Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0.
The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities).
Change from Baseline was calculated as the Baseline value - Month 24 value.
A positive change from Baseline value indicates improvement.
|
Baseline and month 24
|
|
Change From Baseline to Month 24 in the Physician Global Assessment
大体时间：Baseline and month 24
|
The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites).
Change from Baseline was calculated as Baseline value - Month 24 value.
A positive change from Baseline indicates improvement.
|
Baseline and month 24
|
|
Percent Change From Baseline to Month 24 in Physician Global Assessment
大体时间：Baseline and Month 24
|
The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement. |
Baseline and Month 24
|
|
Change From Baseline to Month 24 in Patient Global Assessment
大体时间：Baseline and Month 24
|
The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis.
Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites).
Change from Baseline was calculated as Baseline value - Month 24 value.
A positive change from Baseline indicates improvement.
|
Baseline and Month 24
|
|
Percent Change From Baseline to Month 24 in Patient Global Assessment
大体时间：Baseline and month 24
|
The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis.
Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites).
Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100.
A positive change from Baseline indicates improvement.
|
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)
大体时间：Baseline and Month 24
|
The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment.
This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement.
The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis.
|
Baseline and Month 24
|
|
Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24
大体时间：Baseline and Month 24
|
Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor).
|
Baseline and Month 24
|
合作者和调查者
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出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年8月1日
初级完成 (实际的)
2005年8月1日
研究完成 (实际的)
2009年9月1日
研究注册日期
首次提交
2005年8月5日
首先提交符合 QC 标准的
2005年8月5日
首次发布 (估计)
2005年8月9日
研究记录更新
最后更新发布 (估计)
2014年4月24日
上次提交的符合 QC 标准的更新
2014年3月24日
最后验证
2014年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.