A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)
2015年5月29日 更新者：Merck Sharp & Dohme LLC
Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.
This 14-week study will observe the gene expression of certain immune cells in patients with rheumatoid arthritis who receive etanercept, infliximab, and adalimumab.
Patients at the National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to receive an anti-TNF agent will be asked to participate in this study.
Patients will receive their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples collected during the study and analyzed by the laboratory.
Patient's response to their treatment will also be studied based on x-rays and other examinations.
研究概览
详细说明
Only patients who - regardless of this study - are scheduled and permitted to receive anti-TNF-alpha treatment because of their RA will be asked to participate.
No patient will be recruited only for the sake of the study.
The prescribing physicians will not be influenced by the study as to what form of anti-TNF-alpha therapy they should select.
研究类型
观察性的
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
Subjects will be recruited from a single center at the National Institute of Rheumatology and Physiotherapy, Budapest, the largest center for biological therapy in Hungary.
Subjects will be patients who are scheduled and permitted to receive anti-TNF-alpha treatment due to their rheumatoid arthritis.
描述
Inclusion Criteria:
- Must have active RA (DAS28 >5.1)
- Must have x-ray evidence of an erosive disease,
- Must be eligible for but have never received any anti-TNF treatment,
- Must fulfill the 1987 criteria of the American College of Rheumatology classification criteria for a diagnosis of RA, for at least 3 months,
- Must have failed standard therapy (methotrexate or leflunomide).
Exclusion Criteria:
- Must not be a women who is pregnant or breastfeeding,
- Must not have a history of any malignancy,
- Must not have an active infection,
- Must not be prone to infection,
- Must not have tuberculosis, hepatitis B, hepatitis C, or HIV,
- Must not have septic arthritis of a native prosthetic joint within the last 12 months,
- Must not have NYHA grade 3 or 4 heart failure,
- Must not have a history of demyelinating disease or systemic lupus erythematosis.
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 |
|---|---|
|
ETA
RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly
|
etanercept 50 mg subcutaneously once weekly
其他名称：
|
|
IFX
RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6
|
infliximab 3 mg/kg IV at Weeks 0, 2, and 6
其他名称：
|
|
ADA
RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly
|
adalimumab 40 mg subcutaneously biweekly
其他名称：
|
|
non-diseased controls
Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Gene expression (under- or overexpression) in the peripheral blood mononuclear cells
大体时间：Weeks 0, 4, and 14.
|
Weeks 0, 4, and 14.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Disease Activity measured by DAS28
大体时间：Weeks 0 and 14
|
Weeks 0 and 14
|
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。
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9月1日
初级完成 (预期的)
2009年7月1日
研究完成 (预期的)
2009年7月1日
研究注册日期
首次提交
2008年7月25日
首先提交符合 QC 标准的
2008年7月28日
首次发布 (估计)
2008年7月29日
研究记录更新
最后更新发布 (估计)
2015年6月1日
上次提交的符合 QC 标准的更新
2015年5月29日
最后验证
2015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.