Study of Arthritis and Related Conditions
Studies of the Pathogenesis and Natural History of Arthritis and Related Conditions
This research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions.
Patients will be evaluated clinically, radiographically and serologically, and standardized data will be uniformly collected on all patients.
Additional imaging using sensitive MRI methods will be obtained in some patients.
The collected blood and tissue will be utilized for laboratory studies to continue research on the pathogenic mechanisms of rheumatoid arthritis and related autoimmune joint diseases.
Data from the history and physical examination as well as several disability questionnaires in the adult and pediatric population will be used to phenotypically characterize these patients and assess outcome and functional status.
Any medical care recommended or provided to the patients will be consistent with routine standards of practice and provided in consultation with the patient's referring physician.
研究概览
地位
完全的
条件
详细说明
This research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions.
Patients will be evaluated clinically, radiographically and serologically, and standardized data will be uniformly collected on all patients.
Additional imaging using sensitive MRI methods will be obtained in some patients.
The collected blood and tissue will be utilized for laboratory studies to continue research on the pathogenic mechanisms of rheumatoid arthritis and related autoimmune joint diseases.
Data from the history and physical examination as well as several disability questionnaires in the adult and pediatric population will be used to phenotypically characterize these patients and assess outcome and functional status.
Any medical care recommended or provided to the patients will be consistent with routine standards of practice and provided in consultation with the patient's referring physician.
研究类型
观察性的
注册 (实际的)
697
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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Maryland
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Bethesda、Maryland、美国、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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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
- 孩子
- 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 with known or suspected arthritis
描述
- INCLUSION CRITERIA:
No age limits.
History of inflammatory synovitis of at least one or more swollen joints.
Patient's ability and willingness to give informed consent or in the pediatric patients, the parent's willingness to give informed consent and the patient's willingness to assent to the protocol whenever possible.
EXCLUSION CRITERIA:
None if patients fulfill inclusion criteria.
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 |
|---|
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Subjects with known or suspected arthritis
Subjects with known or suspected arthritis will be evaluated longitudinally
|
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 |
|---|---|---|
|
Determine patterns of arthritis
大体时间：End of the study
|
Evaluate natural history and disease trajectories in rheumatoid arthritis
|
End of the study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Confirmatory Studies In RA and related diseases
大体时间：End of the study
|
We would like to continue confirmatory studies and test whether serologic disease markers identified early in the course of the disease are indeed markers of disease severity in patients with more established forms of the disease.
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End of the study
|
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Co-culture experiments using synovial tissue and surgical cartilage specimens
大体时间：End of the study
|
The erosive potential of some but not all forms of arthritis is still poorly understood.
We propose to resume co-culture experiments using synovial tissue and surgical cartilage specimens to develop a tissue model of bone erosions using the bioreactor
|
End of the study
|
|
MRI Imaging in RA and related diseases
大体时间：End of the study
|
We would like to use patients from this cohort to develop the analysis of MRI images, including three dimensionally reconstructed images, and test their use in the evaluation of joint damage and impact on early diagnosis and therapeutic decisions.
|
End of the study
|
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Collection of DNA in RA and related diseases
大体时间：End of the study
|
Genetic associations need to be tested in large populations of patients with heterogenous diseases.
We would like to continue the collection of DNA in a cohort of clinically well-characterized patients to allow for genetic analysis once a critical body of patients has been collected.
|
End of the study
|
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Evaluation of early disability in RA and related diseases
大体时间：End of the study
|
Analysis of the degree of early disability resulting from inflammatory arthritis in the early synovitis cohort patients is currently ongoing.
We intend to continue work with the rehabilitation department on the analysis of the extent of disability related to the inflammatory conditions and associated factors in the adult and pediatric population.
|
End of the study
|
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Assess cytokine profiles
大体时间：End of the study
|
We would like to comprehensively assess cytokine profiles in the serum of patients with pauciarticular, poly-articular and systemic onset JRA and the influence of response to treatment on cytokine changes.
|
End of the study
|
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Correlate the cartilage and bone markers of tissue destruction and repair with MRI images
大体时间：End of the study
|
We would further like to correlate the cartilage and bone markers of tissue destruction and repair with the amount of damage seen on MRI in the different patient disease subsets.
|
End of the study
|
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Determine the degree of early disability
大体时间：End of the study
|
Very subtle degrees of early disability have been seen in patients with relatively short disease duration.
We would like to determine the degree of early disability in JRA patients and correlate measures of disability with the number, joint location and degree of joint damage on MRI.
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End of the study
|
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。
调查人员
- 首席研究员：James D Katz, M.D.、National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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 (实际的)
2000年10月3日
初级完成 (实际的)
2021年3月10日
研究完成 (实际的)
2021年3月10日
研究注册日期
首次提交
2000年10月4日
首先提交符合 QC 标准的
2000年10月4日
首次发布 (估计)
2000年10月5日
研究记录更新
最后更新发布 (实际的)
2021年3月12日
上次提交的符合 QC 标准的更新
2021年3月11日
最后验证
2021年3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.