Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Number of patients with modification of Orencia administration condition
研究概览
简要总结
Database analysis:
- To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)
- To describe joint population of Orencia
- To assess the impact of the treatment on health status of the treated population as assessed by morbid-mortality criteria
- To describe therapeutic strategies and use of health services
详细描述
- Observational Model: Historic cohort generated from Société Française de Rhumatologie's (SFR) Orencia and Rheumatoid Arthritis (ORA) registry
- Sampling Method: all physicians and sites taking in charge RA patients received an invitation mailing to participate to ORA
- Minimum Age: 18 years old at Orencia initiation
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
- •Adult outpatients, male or female aged ≥ 18 years old
- •Diagnosed with a rheumatoid arthritis according to ACR criteria
- •Treated with Orencia according to usual practice conditions from June 1st 2007
- •Agreeing to participate
排除标准
- •Patients treated by Orencia in the context of clinical trials
研究组 & 干预措施
RA patients treated by Orencia
RA patients treated by Orencia according to usual practice from June 1st 2007
干预措施: Orencia (Drug)
结局指标
主要结局
Number of patients with modification of Orencia administration condition
时间窗: Up to 5 Years
Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria]
时间窗: Up to 5 Years
EULAR response will be measured every 6 months during 5 years
Response over the time will be assessed over 5 years on EULAR response, LDAS
时间窗: Up to 5 years
Number of patients disease progression with no prior improvement
时间窗: Up to 5 Years
Number of patients discontinued and switched from Orencia
时间窗: Up to 5 Years
Number of patients with first Remission state
时间窗: Up to 5 Years
Change from DAS28 \[C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)\] measured at treatment initiation \<2.6 DAS28 will be measured every 6 months during 5 years
Number of patients with first clinically significant Disease Activity Score (DAS) change
时间窗: Up to 5 Years
Change from DAS28 \[C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)\] measured at treatment initiation ≥ 1.2 DAS28 will be measured every 6 months during 5 years
Incidence rate of any type of Adverse events related to Orencia
时间窗: Up to 5 Years
Number of patients with first Low Disease Activity State (LDAS)
时间窗: Up to 5 Years
Change from DAS28 \[C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)\] measured at treatment initiation ≤ 3.2 DAS28 will be measured every 6 months during 5 years
Number of patients with specific predefined events
时间窗: Up to 5 Years
Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death
Number of patients disease progression with prior improvement
时间窗: Up to 5 Years
次要结局
未报告次要终点