NCT01557348已完成不适用
A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,239
- 主要终点
- Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6
研究概览
简要总结
This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 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
- •Adult patients, >/= 18 years of age
- •Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy
- •Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics
排除标准
- •Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment
结局指标
主要结局
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6
时间窗: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6
The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour \[mm/hr\]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.
次要结局
- Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12(Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12)
- Least Squares Mean Change From Baseline in TJC at Months 6 and 12(Baseline, Month 6, and Month 12)
- Least Squares Mean Change From Baseline in SJC at Months 6 and 12(Baseline, Month 6, and Month 12)
- Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12(Baseline, Month 6, and Month 12)
- Least Squares Mean Change From Baseline in ESR at Months 6 and 12(Baseline, Month 6, and Month 12)
- Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12(Baseline, Month 6, and Month 12)
- Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12(Baseline, Month 6, and Month 12)
- Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12(Baseline, Month 6, and Month 12)
- Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12(Baseline, Month 6, and Month 12)
- Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12(Baseline, Month 6, and Month 12)
- Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy(Month 6 and Month 12)
- Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice(Up to 12 months)
- Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death(Up to 12 Months)
- Number of Participants With Reasons for Discontinuation of the First TNFi Therapy(Day 1 (Study entry visit))
- Number of Participants With Previous TNFi Therapy(Day 1 (Study entry visit))
- Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy(Day 1 (Study entry visit))
- Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi(Baseline)
研究者
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