NCT02402686已完成不适用
Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 18
- 主要终点
- Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study
研究概览
简要总结
The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.
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 RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria
- •Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label
- •Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate
排除标准
- •Treatment with tocilizumab more than 8 weeks prior to enrollment
- •Failure to meet local tocilizumab label indication criteria
- •Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy
- •Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy
- •History of any other autoimmune or joint inflammatory disease
研究组 & 干预措施
Tocilizumab for RA in Routine Clinical Practice
Participants from routine clinical practice in Hungary who are receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to tocilizumab therapy as per the local label are eligible for observation.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study
时间窗: Baseline, end of study (up to 24 weeks)
次要结局
- Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6(Up to 24 weeks)
- Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8(Up to 24 weeks)
- Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6(Up to 24 weeks)
- Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period(Week 24)
- Percentage of Participants Treated Previously with a Tumor Necrosis Factor (TNF) Inhibitor/Other Biologic and Low Dose Methotrexate (Less Than 10 Milligrams/Week)(Up to 24 weeks)
- Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study(Baseline, end of study (up to 24 weeks))
- Percentage of Participants with Reasons for SC Tocilizumab Monotherapy(Up to 24 weeks)
- Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study(Baseline, Week 24)
- Percentage of Participants with Adverse Events(Up to 24 weeks)
- Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups(Baseline, end of study (up to 24 weeks))
- Number of Tocilizumab SC Injections per Participant During Observational Treatment Period(Up to 24 weeks)
- Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period(Baseline, Week 24)
- Percentage of Participants with Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission(Up to 24 weeks)
- Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations(Up to 24 weeks)
- Percentage of Participants on SC Tocilizumab First Line Monotherapy(Up to 24 weeks)
研究者
研究点 (18)
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