Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
研究概览
简要总结
This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 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
- •Moderate to severe active RA (European League Against Rheumatism [EULAR] criteria)
- •Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
- •Initiating treatment with tocilizumab according to SPC
排除标准
- •Rheumatic autoimmune disease other than RA
- •Prior history or current inflammatory joint disease other than RA
- •Previous treatment with any biological drug used in the treatment of RA
- •Previous treatment with tocilizumab
- •Any contraindication to treatment with tocilizumab
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- •Pregnant women or nursing (breastfeeding) mothers
研究组 & 干预措施
Tocilizumab in Moderate to Severe Active RA
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed. The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
时间窗: Baseline up to Week 24
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.
次要结局
- Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria(Baseline, Week 24)
- Number of Participants Who Discontinued Treatment Due to Lack of Efficacy(Baseline up to Week 24)
- Time to Discontinuation Due to Lack of Efficacy(Baseline up to Week 24)