Clinical Outcomes,Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab. A Multicenter Post-Marketing Observational Study in Routine Clinical Use
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 82
- 试验地点
- 12
- 主要终点
- DAS28 (Disease Activity Score in 28 Joints)
研究概览
简要总结
This is a prospective, single-arm, post marketing observational study in adult patients with active rheumatoid arthritis (RA) who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept.
The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.
详细描述
This is a prospective, single-arm, post marketing observational study in adult patients with active RA who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept.
The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to Adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.
Study Objectives:
Primary objective:
To assess the effectiveness of the treatment with adalimumab in patients with rheumatoid arthritis (RA) that have failed or presented an incomplete response to current treatment with either infliximab or etanercept.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 and <75 years of age that meet the American College of Rheumatology (ACR) criteria for RA.
- •Patients with active RA defined as:
- •≥3 tender joints and ≥3 swollen joints, or
- •DAS 28 score >3.1
- •Patients who are discontinuing treatment with either infliximab or etanercept due to:
- •Lack of efficacy, or
- •Incomplete response.
- •Patients that, in the opinion of the physician could result beneficiated with the locally approved treatment scheme of adalimumab
- •Those patients who switch from infliximab or etanercept to adalimumab has been done in the last 60 days could be included in the study.
排除标准
- •The following patients will not be included in the study:
- •Patients who have active infections.
- •Patients with latent TB. For this protocol, evidence of latent TB infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. Any suggested data on the clinical history or chest x-ray.
- •Patients participating into another study or clinical trial
- •Any condition that according to the criteria of the participating physician represents an obstacle for study conduct and/or represents a potential unacceptable risk for patients.
结局指标
主要结局
DAS28 (Disease Activity Score in 28 Joints)
时间窗: Baseline and Weeks 8,16 and 24
The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (\<= 2.6), Low Disease Activity (\>2.6 to \<=3.2), Moderate Disease Activity (\>3.2 to \<= 5.1) and High Disease Activity (\>5.1). The mean change in DAS 28 score from baseline to each visit is presented.
Tender Joint Count and Swollen Joint Count
时间窗: Baseline and Weeks 8,16 and 24
The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented.
Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)
时间窗: Baseline and Weeks 8,16 and 24
Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit.
次要结局
- Evaluate the Compliance and Clinical Tolerability With Adalimumab(Baseline to Week 24)