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Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

2011年9月8日 更新者:Pfizer

Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis

This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.

研究概览

地位

完全的

干预/治疗

详细说明

The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .

研究类型

观察性的

注册 (实际的)

89

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

The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.

描述

Inclusion Criteria:

  • Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
  • Patients treated as an outpatient

Exclusion Criteria:

  • Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
  • Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
  • Patients with sepsis or risk of sepsis should not be treated.

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
Treatment Group Enbrel

The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits.

其他名称:
  • 依那西普

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 Achieving BASDAI 40 Response at Week 24
大体时间:Week 24
BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.
Week 24

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in BASDAI at Week 12 and 24
大体时间:Baseline, Week 12 and Week 24
BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.
Baseline, Week 12 and Week 24
Change From Baseline in the BASFI at Weeks 12 and 24
大体时间:Baseline, Week 12 and Week 24
BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
Baseline, Week 12 and Week 24
Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24
大体时间:Week 12 and Week 24
Measured using a 100mm VAS ranging from 0=very good to 100=very bad.
Week 12 and Week 24
Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24
大体时间:Week 12 and Week 24
Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.
Week 12 and Week 24
Mean Duration of Morning Stiffness
大体时间:Week 12 and Week 24
Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).
Week 12 and Week 24
Change From Baseline in ASQoL at Week 12 and Week 24
大体时间:Baseline, Week 12 and Week 24
ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).
Baseline, Week 12 and Week 24
Percentage of Participants Without Enthesitis
大体时间:Week 12 and Week 24
Week 12 and Week 24
Percentage of Participants Without Peripheral Arthritis
大体时间:Week 12 and Week 24
Week 12 and Week 24
Mean Occiput-to-wall Distance at Week 12 and Week 24
大体时间:Week 12 and Week 24
Week 12 and Week 24
Spine Agility Function by Schober Test
大体时间:Week 12 and Week 24
Schober test determines agility of lumbar spine. It measures participant's ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers.
Week 12 and Week 24
Spine Agility Function by Ott Test
大体时间:Week 12 and Week 24
The Ott index determines the agility of the thoracic spine.
Week 12 and Week 24

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

2008年5月1日

初级完成 (实际的)

2010年3月1日

研究完成 (实际的)

2010年3月1日

研究注册日期

首次提交

2010年8月24日

首先提交符合 QC 标准的

2010年8月24日

首次发布 (估计)

2010年8月25日

研究记录更新

最后更新发布 (估计)

2011年9月12日

上次提交的符合 QC 标准的更新

2011年9月8日

最后验证

2011年9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.

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