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临床试验/NCT02804204
NCT02804204Unknown不适用

Analysis of Circulant Rheumatoid Factor, Cyclic Citrullinated Anti-peptide Anti-bodies and Albumin as a Potential Predictor in the Response to the Treatment With Anti-TNF in Patients With Rheumatoid Arthritis

Hospital Universitari Vall d'Hebron Research Institute19 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
200
试验地点
19
主要终点
Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.

研究概览

简要总结

Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor, cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24 weeks of treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders
  • Over 18 years old
  • Diagnosis of rheumatoid arthritis according to ACR criteria
  • Patients that initiate treatment with anti-TNF drugs according to clinical practice, both in naïve anti-TNF patients and patients after first anti-TNF failure
  • Patients able to follow the protocol requirements
  • Patients that signed the informed consent

排除标准

  • Patients with known hypersensitivity to investigational products
  • Patients with tuberculosis, or severe infections like sepsis or opportunistic infections
  • Patients with moderate/severe cardiac insufficiency (NHYA classification Class III/IV)
  • Patients that according to the investigator criteria can not participate in the study or complete the study questionnaires
  • Pregnant or fertile woman that does not use a contraception method

研究组 & 干预措施

Anti-TNF

干预措施: Anti-TNF (Drug)

结局指标

主要结局

Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.

时间窗: 24 weeks

Anti-TNF treatment response based on circulant rheumatoid factor

时间窗: 24 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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