Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy (ASSIAL)
2017年1月19日 更新者：Pfizer
Assial - Anti Tnf Treatment In Ankylosing Spondylitis: An Observational Cohort Study In Italy
Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.
研究概览
详细说明
retrospective and prospective 150
研究类型
观察性的
注册 (实际的)
152
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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Bologna、意大利、40138
- U.O.S. Reumatologia - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola-Malpighi
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Brescia、意大利、125128
- Piazzale Spedali Civili
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Cagliari、意大利、09100
- Policlinico Di Cagliari, Dipartimento Di Scienze Mediche
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Ferrara、意大利、44100
- Arcispedale Sant'Anna
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Firenze、意大利、50143
- Via Torregalli, 3
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Milano、意大利、20132
- Fondazione San Raffaele del Monte Tabor
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Milano、意大利、20122
- Ospedale Ortopedico G. Pini
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Napoli、意大利、80131
- Policlinico Universitario, II Universita
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Padova、意大利、35128
- Policlinico Universitario
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Palermo、意大利、90134
- Divisione di Reumatologia
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Palermo、意大利、90146
- Policlinico Universitario P. Giaconne
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Prato、意大利
- Azienda USL 4 di Prato
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Roma、意大利
- Policlinico Umberto I
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Roma、意大利、00128
- Università Campus Bio-Medico di Roma- Policlinico Universitario Campus Bio-medico di Roma
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Torino、意大利、10128
- Ospedale Mauriziano Umberto I
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Udine、意大利、33100
- Policlinico Universitario
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Verona、意大利、37126
- Ospedale Borgo Trento - Clinica Reumatologica
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CT
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Catania、CT、意大利、95100
- Unita Operativa Semplice di Reumatologia
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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
概率样本
研究人群
ankylosing spondylitis
描述
Inclusion Criteria:
retrospective:12 months at least first anti-TNF therapy prospective: at maximum 6 months observation AS patients with axial involvement
Exclusion Criteria:
patients in other AS studies involved
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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观察性的
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in real life of drug,dosage,frequency and duration
其他名称：
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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 Unchanged First Line Anti-TNF Treatment Up to Month 18
大体时间：Baseline up to Month 18
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First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab.
In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.
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Baseline up to Month 18
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Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18
大体时间：Baseline, Month 18
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BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS.
Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity).
The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4.
This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5.
The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.
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Baseline, Month 18
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Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity
大体时间：Month 12, 18
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Low disease activity was defined as a BASDAI score of less than or equal to (<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS.
The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.
In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.
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Month 12, 18
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18
大体时间：Month 18
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ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant's quality of life (QoL).
It consisted of 18 questions to be completed by the participant.
Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0).
Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life.
Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period).
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Month 18
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C Reactive Protein Level at Baseline
大体时间：Baseline
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C reactive protein was measured from blood samples as a marker for inflammation.
Higher levels were indicative of more inflammation.
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Baseline
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Erythrocyte Sedimentation Rate at Baseline
大体时间：Baseline
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Erythrocyte sedimentation rate was a laboratory test that provided a non-specific measure of inflammation.
The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).
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Baseline
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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
2013年7月1日
初级完成 (实际的)
2015年10月1日
研究完成 (实际的)
2015年11月1日
研究注册日期
首次提交
2013年5月14日
首先提交符合 QC 标准的
2013年5月14日
首次发布 (估计)
2013年5月17日
研究记录更新
最后更新发布 (实际的)
2017年3月9日
上次提交的符合 QC 标准的更新
2017年1月19日
最后验证
2017年1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.