Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis (PRETEA)
2012年5月7日 更新者:Pfizer
Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis
The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these findings in patients who switch from one to another anti-TNF due to inefficacy under usual clinical practice conditions in Spain.
研究概览
详细说明
A sample size of 240 patients, 120 of them exposed and 120 not exposed to factors of response.
Sample will be obtain from all the consecutive patients attending the rheumatology settings included in the study who fulfill the inclusion criteria
研究类型
观察性的
注册 (实际的)
132
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
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Madrid、西班牙、28006
- Pfizer Investigational Site
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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
Patients with active ankylosing spondylitis treated in rheumatology units
描述
Inclusion Criteria:
- Patients diagnosed of active AS who will start anti-TNF therapy following standard clinical practice as per summary of product characteristics doses.
- >18 years, both genders, any disease duration
- Signature of informed consent
Exclusion Criteria:
- Previous treatment with biological therapies
- Active tuberculosis infection (local guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy must be followed)
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 |
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1
Patients diagnosed with active AS who start anti-TNF therapy according to standard clinical practice.
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If the patients do not response to first AntiTNF treatment, Investigator can switch to another anti TNF.Spanish Guidelines will be provided to the investigators, which recommend stopping biologics if there is an inadequate response after 16w of therapy and switch to another biologic.
Responsive patients to the first anti-TNF who continue with this first anti-TNF adjusting dose treatment according to the Spanish guidelines or investigator criteria.
The doses for each Anti TNF will be done following specific SmPc and under Investiagtor criteria
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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 |
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Percentage of Participants With a Clinical Response
大体时间:Week 16
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Assessment of clinical response was as per investigator's discretion.
Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.
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Week 16
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment
大体时间:Week 32
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High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) >15 mg/Liter (mg/L);time from onset of disease <10 years;total spinal pain >30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) <4.5 cm, mean score on 10 cm VNS evaluating functional capacity.
Assessment of response was per investigator.
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Week 32
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Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment
大体时间:Week 32
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Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity.
Assessment of response was as per investigator's criteria.
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Week 32
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Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16
大体时间:Week 16
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Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity.
Assessment of response was as per investigator's criteria.
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Week 16
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Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
大体时间:Week 16
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ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation.
ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.
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Week 16
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Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy
大体时间:Week 16
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Week 16
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Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks
大体时间:Week 32
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ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation.
ASAS 40 = 40% improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.
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Week 32
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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
2009年3月1日
初级完成 (实际的)
2011年5月1日
研究完成 (实际的)
2011年5月1日
研究注册日期
首次提交
2009年5月11日
首先提交符合 QC 标准的
2009年5月12日
首次发布 (估计)
2009年5月13日
研究记录更新
最后更新发布 (估计)
2012年6月19日
上次提交的符合 QC 标准的更新
2012年5月7日
最后验证
2012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.
Treatment switching的临床试验
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中
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Universitaire Ziekenhuizen KU LeuvenLaboratoires Thea招聘中