Long-term Experience With Abatacept SC in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,954
- 试验地点
- 1
- 主要终点
- Key Primary: Median time and estimation of treatment retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept subcutaneous (SC) over 24 months in routine clinical practices
研究概览
简要总结
The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patients ≥18 years old at treatment initiation
- •Patients diagnosed with established moderate to severe active RA as per the 1987 ACR criteria/2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Rheumatoid Arthritis Classification Criteria
- •Patients naïve of Abatacept IV and who at their physician's discretion are initiated with Abatacept SC. In countries where required (e.g. Germany and Spain), patients naïve of Abatacept IV and who at their physician's discretion have been initiated with Abatacept SC at least 1 month prior to enrollment visit up to 6 months if baseline and disease characteristics data are available
- •For Spanish pharmacogenomic sub-study:
- •Caucasian patient and from European ancestry
- •Patient for whom a collection of blood sample before the initiation of abatacept is possible or available (blood sample was taken in routine practice before the study enrolment)
- •Patient who agreed to participate in this substudy and provide a specific signed Pharmacogenomic Blood RNA informed consent
- •In the UK, the ART substudy will be proposed to all patients enrolled in ASCORE from amendment approval and application date
排除标准
- •Patients who are currently included in any interventional clinical trial in RA
结局指标
主要结局
Key Primary: Median time and estimation of treatment retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept subcutaneous (SC) over 24 months in routine clinical practices
时间窗: Up to 24 Months
Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort
时间窗: Up to 24 Months
Description include concomitant treatments, dosage and adherence to treatment
Co-Primary: Description of the major characteristics of Abatacept SC treated patients (joint population) at treatment initiation
时间窗: Up to 24 Months
Major characteristics of population of patients (joint population depending on previous prescriptions) include socio-demographic data, medical history, disease history, co-morbidities and clinical measures
Co-Primary: Impact of the Abatacept SC treatment on health status of each population of patients over time as assessed by morbi-mortality criteria and safety
时间窗: Up to 24 Months
Morbi-mortality criteria include clinical measures, Patient Reported Outcomes (PRO) including self-completion quality of life (QoL) questionnaires and healthcare resource use, incidence of local site injection reaction, incidence of long-term adverse events (AE), withdrawal from study due to AE and Serious Adverse Events (SAE)
Co-Primary: Acceptability of the pre-filled pen device based on questionnaires
时间窗: Up to 24 Months
Patients using the pre-filled pen will complete questionnaires on overall acceptability of the pre-filled pen device, injection site pain assessment and experience with previous injections
次要结局
- Major determinants of Abatacept SC retention rate(Up to 24 months)
- Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified(Up to 24 months)
- Time to discontinuation of Abatacept (whatever the formulation, SC or IV)(Up to 24 months)