Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Participants With Rheumatoid Arthritis (RA) Who Are Treated With Abatacept or Tumor Necrosis Factor Inhibitors in Australia
2022年2月22日 更新者：Bristol-Myers Squibb
Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Patients With Rheumatoid Arthritis Who Are Treated With Abatacept or Tumour Necrosis Factor Inhibitors. An Analysis From the Optimising Patient Outcome in Australian Rheumatology (OPAL) Registry.
An observational study assessing the impact of anti-citrullinated antibody (ACPA) in rheumatoid arthritis (RA) participants who have received abatacept or tumour necrosis factor inhibitors (TNFi) from the Optimising Patient outcome in Australian rheumatoLogy (OPAL) registry
研究概览
研究类型
观察性的
注册 (实际的)
2052
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
-
-
-
Canberra City、澳大利亚
-
-
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 至 95年 (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
Patients with a diagnosis of rheumatoid arthritis (RA) who have received a TNFi or abatacept and registered in the OPAL registry
描述
Inclusion Criteria:
- Diagnosed with rheumatoid arthritis
- Have a baseline ACPA recorded
- Received either abatacept or a TNFi (adalimumab, certolizumab, etanercept or golimumab) during the sample selection window 1 August 2006 to 30 June 2017
Exclusion Criteria:
- Patients who have died
- Patients with concomitant inflammatory diseases (e.g. ankylosing spondylitis, psoriatic arthritis, Crohn's disease, ulcerative colitis)
- Patients who have no visit data recorded (even if medication data is available)
Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|
|
Participants RA who have received a TNFi
|
非介入式
|
|
Participants with RA who have received abatacept
|
非介入式
|
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 |
|---|---|---|
|
ACPA (Anti-cyclic citrullinated peptide) status
大体时间：Pre-Index
|
ACPA-positive greater than or equal to 5 Ru/mL in Australia, greater than or equal to 20 Ru/mL in US
|
Pre-Index
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants with positive ACPA
大体时间：Index
|
ACPA-positive greater than or equal to 5 Ru/mL in Australia, greater than or equal to 20 Ru/mL in US
|
Index
|
|
Number of participants with negative ACPA
大体时间：Index
|
ACPA-negative less than or equal to 5 Ru/mL in Australia, less than or equal to 20 Ru/mL in US
|
Index
|
|
CDAI (clinical disease activity index) score
大体时间：Index plus or minus 1 month
|
Remission CDAI <2.9 Low disease activity CDAI ≥ 2.9 but <10.0 Moderate disease activity CDAI ≥ 10.1 but <22.0 High disease activity CDAI ≥ 22.0
|
Index plus or minus 1 month
|
|
CDAI (clinical disease activity index) score
大体时间：12 months plus or minus 3 months
|
Remission CDAI <2.9 Low disease activity CDAI ≥ 2.9 but <10.0 Moderate disease activity CDAI ≥ 10.1 but <22.0 High disease activity CDAI ≥ 22.0
|
12 months plus or minus 3 months
|
|
DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score
大体时间：Index plus or minus 1 month
|
The DAS-28 CRP-3 is a measure of disease activity in rheumatoid arthritis (RA) that assesses 28 joints in RA commonly affected.
The DAS-28 CRP 3 takes into account tender and swollen joint counts and CRP level (measure of inflammation in the blood).
The DAS-28 CRP 3 measure does not include patient global assessment of health.
|
Index plus or minus 1 month
|
|
DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score
大体时间：12 months plus or minus 3 months
|
The DAS-28 CRP-3 is a measure of disease activity in rheumatoid arthritis (RA) that assesses 28 joints in RA commonly affected.
The DAS-28 CRP 3 takes into account tender and swollen joint counts and CRP level (measure of inflammation in the blood).
The DAS-28 CRP 3 measure does not include patient global assessment of health.
|
12 months plus or minus 3 months
|
|
Number of participants with treatment persistence
大体时间：Approximately 11 years and 5 months
|
Approximately 11 years and 5 months
|
|
|
Number of participants with treatment discontinuation
大体时间：Approximately 11 years and 5 months
|
Approximately 11 years and 5 months
|
|
|
Number of participants identified as taking abatacept
大体时间：Index
|
Index
|
|
|
Number of participants identified as taking TNFi (tumor necrosis factor inhibitor)
大体时间：Index
|
Index
|
|
|
Number of participants that achieved remission
大体时间：12 months plus or minus 3 months
|
Remission CDAI <2.9 Low disease activity CDAI ≥ 2.9 but <10.0 Moderate disease activity CDAI ≥ 10.1 but <22.0 High disease activity CDAI ≥ 22.0
|
12 months plus or minus 3 months
|
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。
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)
2017年10月4日
初级完成 (实际的)
2019年3月5日
研究完成 (实际的)
2019年12月18日
研究注册日期
首次提交
2018年9月6日
首先提交符合 QC 标准的
2018年9月6日
首次发布 (实际的)
2018年9月10日
研究记录更新
最后更新发布 (实际的)
2022年3月9日
上次提交的符合 QC 标准的更新
2022年2月22日
最后验证
2022年2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.
非介入式的临床试验
-
Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation Trust完全的
-
Charite University, Berlin, Germany招聘中