An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria (BEFLEX)
2014年5月28日 更新者：Pfizer
An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria - Beflex Study
With the new reimbursement criteria, we want:
To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year.
To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment
研究概览
详细说明
100 patients will be followed for at least 1 year
研究类型
观察性的
注册 (实际的)
140
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Leuven、比利时、3000
- Herestraat 49
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-
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
取样方法
非概率样本
研究人群
All subjects enrolled should meet the usual prescribing criteria for Enbrel as per local reimbursement criteria and should be entered into the study at the investigator's discretion.
It is requested to include patients in a consecutive manner as much as possible.
描述
Inclusion Criteria:
- Patient restarts or is starting treatment with Enbrel for his/her psoriasis in alignment with reimbursement criteria
- Patients ≥18 year
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
N/A
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Plaque psoriasis patients
Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria
|
Enbrel SC 50mg once weekly or 25mg twice weekly
|
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 |
|---|---|---|
|
Number of Weeks of Etanercept Treatment
大体时间：Baseline up to end of study (90 weeks)
|
Average duration of time in weeks for treatment with etanercept was reported.
|
Baseline up to end of study (90 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Weeks of Off-Treatment
大体时间：Baseline up to end of study (90 weeks)
|
Total duration of time in weeks for which participants discontinued etanercept treatment was reported.
|
Baseline up to end of study (90 weeks)
|
|
Psoriasis Area and Severity Index (PASI) Score
大体时间：Start and end of cycle 1, 2, 3
|
Combined assessment of lesion severity and area affected into single score.
Body was divided into 4 sections: head, arms, trunk, and legs.
For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%.
Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum.
Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
|
Start and end of cycle 1, 2, 3
|
|
Percentage of Body Surface Area (BSA) Affected by Psoriasis
大体时间：Start and end of cycle 1, 2, 3
|
Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA.
Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)].
The total BSA affected was the summation of individual regions affected.
|
Start and end of cycle 1, 2, 3
|
|
Number of Participants With Reasons for Treatmant Discontinuation
大体时间：Baseline up to end of study (90 weeks)
|
Number of participants who discontinued etanercept before completing the study was reported.
|
Baseline up to end of study (90 weeks)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Who Received Continuous Treatment
大体时间：Baseline up to end of study (90 weeks)
|
Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported.
|
Baseline up to end of study (90 weeks)
|
|
Number of Participants Who Received Intermittent Treatment
大体时间：Baseline up to end of study (90 weeks)
|
Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.
|
Baseline up to end of study (90 weeks)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2011年9月1日
初级完成 (实际的)
2013年6月1日
研究完成 (实际的)
2013年6月1日
研究注册日期
首次提交
2011年9月30日
首先提交符合 QC 标准的
2012年3月15日
首次发布 (估计)
2012年3月19日
研究记录更新
最后更新发布 (估计)
2014年6月30日
上次提交的符合 QC 标准的更新
2014年5月28日
最后验证
2014年5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.