A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 156
- 主要终点
- Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression
研究概览
简要总结
This study involves review and analysis of disease activity in patients with rheumatoid arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and feet taken as part of routine treatment monitoring within a time interval of 12 to 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Secure diagnosis of rheumatoid arthritis
- •Older than 18 years
- •Two consecutive plain radiographs of the hands and feet with a time interval of 12 to 36 months are available. The radiographs are recorded 2003 or later and are in accordance with a defined X-ray protocol.
排除标准
- •Patients who receive Anakinra, Rituximab or Abatacept
研究组 & 干预措施
1
DMARDs
干预措施: DMARDs or Biologics (Drug)
2
Biologics
干预措施: DMARDs or Biologics (Drug)
结局指标
主要结局
Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression
时间窗: Baseline (Day 0) up to 48 months
Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, \<20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = \>80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 \[months\])\*12 months.
次要结局
- Number of Participants Without Radiographic Progression(Baseline (Day 0) up to 48 months)
- Number of Participants Without Erosions(Baseline (Day 0) up to 48 months)
- Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)(Baseline (Day 0) up to 48 months)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Baseline (Day 0) up to 48 months)
- Change From Baseline in C-reactive Protein (CRP)(Baseline (Day 0) up to 48 months)
- Number of Participants With Change From Baseline in Rheumatoid Factor (RF)(Baseline (Day 0) up to 48 months)
- Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)(Baseline (Day 0) up to 48 months)