NCT03663829已完成不适用
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.
Bristol-Myers Squibb0 个研究点目标入组 2,052 人开始时间: 2017年10月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,052
- 主要终点
- ACPA (Anti-cyclic citrullinated peptide) status
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
ACPA (Anti-cyclic citrullinated peptide) status
时间窗: Pre-Index
ACPA-positive greater than or equal to 5 Ru/mL in Australia, greater than or equal to 20 Ru/mL in US
次要结局
- Number of participants with positive ACPA(Index)
- DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score(12 months plus or minus 3 months)
- Number of participants with negative ACPA(Index)
- Number of participants with treatment discontinuation(Approximately 11 years and 5 months)
- Number of participants identified as taking abatacept(Index)
- Number of participants identified as taking TNFi (tumor necrosis factor inhibitor)(Index)
- CDAI (clinical disease activity index) score(12 months plus or minus 3 months)
- Number of participants with treatment persistence(Approximately 11 years and 5 months)
- Number of participants that achieved remission(12 months plus or minus 3 months)
研究者
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