NCT02094326已完成不适用
A Retrospective, Multicentre Observational Study to Assess the Management of Synthetic Disease-modifying Antirheumatic Drug (DMARD) at the Onset of Adverse Events, Intolerance or Lack of Efficacy in Real Life in Patients With Rheumatoid Arthritis
Fundación Andaluza de Reumatología11 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2014年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 试验地点
- 11
- 主要终点
- Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice
研究概览
简要总结
The purpose of this study is to find patterns in the use of non-biological DMARDs as the initial treatment of RA and how adverse events (AEs), intolerance or lack of efficacy may impact therapeutic decisions in real life in the Spanish Andalusian region.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes ≥ 18 years.
- •Patients diagnosed with RA (according to the American College of Rheumatology (ACR) 2010 criteria) between January 2008 and December 2012 and who have initiated treatment with at least one synthetic DMARD during that period.
- •Patients who have given written informed consent for their data to be collected and reviewed.
排除标准
- •Patients who are already participating in a clinical trial/s at the moment of participation in this study.
- •Patients with whom it is suspected there will be insufficient information to complete the study objectives.
结局指标
主要结局
Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice
时间窗: 6 years
次要结局
- Percentage of Patients Who Receive Subcutaneous Methotrexate(6 years)
- Exposure Time of Methotrexate(6 years)
- Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question(6 years)
- Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal(6 years)
- Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment(6 years)
研究者
研究点 (11)
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