Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 主要终点
- Abatacept IV effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation
研究概览
简要总结
The purpose of this study is to assess Abatacept Intravenous (IV) effectiveness in patients with inadequate response to one or more conventional Disease Modifying Against Rheumatism (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation
详细描述
Observational Model:
Other: ReACTION is a study using secondary data originally collected in ACTION study. In ACTION, data were collected prospectively from October 2010 up to 2015 at each clinical visit. In France, data collection started in June 2011
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •All patients enrolled in ACTION with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV will be included in ReACTION
- •ACTION inclusion criteria for France were:
- •Male or female subjects of more than 18 years old
- •Patients with a diagnosis of established moderate to severe active RA
- •Patients who at their physician's discretion are treated with Abatacept (initiated or already on treatment within 3 months) according to routine clinical practice
- •Patients for whom baseline characteristics are available
- •Patients consent for usage of their data in ACTION study
- •Patients who were not included in any interventional clinical trial in RA
排除标准
- 未提供
研究组 & 干预措施
RA patients on Abatacept IV
Rheumatoid Arthritis (RA) patients with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV according to routine clinical practice in France
干预措施: Abatacept (Drug)
结局指标
主要结局
Abatacept IV effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation
时间窗: Up to 2 years of followup
次要结局
- Abatacept effectiveness in the treated population(3, 6, and 12 months and every 3 months up to 2 years of followup)
- Impact of patient and disease characteristics on treatment outcomes(Every 3 months up to 2 years of followup)
- Joint population of French patients with inadequate response to one or more conventional DMARDs including Methotrexate treated with Abatacept IV (demographics, medical history, disease characteristics, previous treatments)(Every 3 months up to 2 years of followup)
- Conditions of Abatacept IV utilization in first line of biologic agents (indication, dosage, administration schedule, treatment duration, concomitant treatments)(Every 3 months up to 2 years of followup)
- Therapeutic strategies over time including change in concomitants treatments(Every 3 months up to 2 years of followup)
- The healthcare resource use as assessed by number of visits to any rheumatologists, hospitalizations(Every 3 months up to 2 years of followup)
- Abatacept effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate of the patients treated with Abatacept IV according to Summary Product Characteristics (SmPC)(Every 3 months up to 2 years of followup)