TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment
研究概览
简要总结
The aim of this non-interventional, prospective, observational study is to assess the effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic treatment in participants with moderate to severe active RA who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland. The length of the entire study will be 24 months.
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
- •participants at least 18 years of age
- •a diagnosis of moderate to severe RA
- •treating physician has made the decision to commence tocilizumab in first line biologic treatment (population of DMARDs inadequate responders or participants who are intolerant to DMARDs) in a routine clinical practice in Poland
- •informed consent
排除标准
- 未提供
研究组 & 干预措施
Cohort of RA Participants
Participants with RA treated with tocilizumab at a dose and duration at the discretion of physician in accordance with the summary of product characteristics as per routine clinical practice were observed for a period of 6 months with the length of entire study for 24 months.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment
时间窗: Month 6
Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment
时间窗: Month 6
次要结局
- Change From Baseline in DAS28 Over Time(Baseline up to Month 6)
- Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)(Baseline up to Month 6)
- Time to Discontinuation(Baseline up to Month 6)
- Change From Baseline in C-Reactive Protein (CRP) Over Time(Baseline up to Month 6)
- Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline(Baseline)
- Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time(Baseline up to Month 6)
- Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate(Baseline up to Month 6)
- Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment(Month 3)
- Percentage of Participants With Discontinuations Due to Lack of Efficacy(Baseline up to Month 6)