NCT02608112已完成不适用
Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year
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
- 291
- 试验地点
- 70
- 主要终点
- Percentage of Participants Who Were on TCZ SC for a Period of 12 Months
研究概览
简要总结
This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants at least 18 years old
- •Participants with moderate to severe RA not previously treated with TCZ (Intravenous [IV] or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another conventional synthetic disease modifying anti-rheumatic drugs (csDMARD)
排除标准
- •Participants taking part in a clinical trial on RA at the time of inclusion
- •Participants with a contra-indication to TCZ SC therapy
研究组 & 干预措施
Participants with Moderate to Severe RA
Participants with moderate or severe RA, naïve to TCZ treatment (IV or SC), and who have no contra-indication to TCZ SC therapy as per the local label are included.
干预措施: Methotrexate (Drug)
Participants with Moderate to Severe RA
Participants with moderate or severe RA, naïve to TCZ treatment (IV or SC), and who have no contra-indication to TCZ SC therapy as per the local label are included.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Percentage of Participants Who Were on TCZ SC for a Period of 12 Months
时间窗: Up to 12 Months
次要结局
- Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP)(Months 3, 6, 12, and 18)
- Simple Disease Activity Index (SDAI)(Months 3, 6, 12, and 18)
- Clinical Disease Activity Index (CDAI)(Months 3, 6, 12, and 18)
- Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response(Months 3, 6, 12, and 18)
- Percentage of Participants Who Were on TCZ SC for a Period of 6 Months(Up to 6 Months)
- Percentage of Participants Who Were on TCZ SC for a Period of 18 Months(Up to 18 Months)
- Percentage of Participants who were on TCZ SC at 6, 12 and 18 Months Among 2 Subgroups: Participants Administered TCZ SC as Monotherapy and Participants Administered TCZ SC with Methotrexate or csDMARD(Up to 18 Months)
- Dose of Concomitant Steroids After Introduction of TCZ SC(Months 6, 12, and 18)
- Number of Participants with Adherence to TCZ SC Using the Compliance Questionnaire of Rheumatology 5 (CQR5) and Participants Diary Data(Months 6, 12, and 18)
- Percentage of Participants with Definitive Discontinuation of Treatment(Up to 18 Months)
- Swollen Joints Count(Months 3, 6, 12, and 18)
- Disease Activity Score Based of 28 Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR)(Months 3, 6, 12, and 18)
- Percentage of Participants Performing All Visits at Hospital/Office Based Rheumatologist(Up to 18 Months)
- Percentage of Participants Taking Sick Leaves or Getting Hospitalized Due to RA(Up to 18 Months)
- Tender Joints Count(Months 3, 6, 12, and 18)
研究者
研究点 (70)
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