A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 主要终点
- Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12
研究概览
简要总结
This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.
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
- •Age >18 years with rheumatoid arthritis (RA)
- •Seropositive participants with RA (positive for rheumatoid factor (RF) and/or anti-Citrullinated Cyclic Peptide [CCP])
- •Active disease despite receiving one or more TNF inhibitors
- •Absence of serious or active infection
排除标准
- •Participants with serious history of heart failure (class New York Heart Association [NYHA] IV) or severe uncontrolled heart disease
- •Participants pregnant or lactating
- •Prior treatment with Mabthera®
- •Participants receiving any other investigational product in the context of other clinical study
- •Participants with known hypersensitivity to rituximab or to any of the excipients
结局指标
主要结局
Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12
时间窗: Baseline, Month 6, Month 12
DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity (100-millimeter \[mm\] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.
次要结局
- Percentage of Serious ADRs(Up to 12 months)
- Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Percentage of Serious AEs(Up to 12 months)
- Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12(Up to 12 months)
- Reasons for Discontinuation of Treatment by Month 6(Baseline to Month 6)
- Reasons for Discontinuation of Treatment by Month 12(Baseline to Month 12)
- Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ)(Up to 12 months)
- Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs)(Up to 12 months)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity(Up to 12 months)
- Percentage of Non-Serious AEs(Up to 12 months)
- Percentage of Non-Serious ADRs(Up to 12 months)