Portuguese Observational Re-Treatment Study of MabThera (PORTSMAB) - A Two-centre Observational Study in Sero-positive Rheumatoid Arthritis (RA) Patients Who Are Non-responders or Intolerant to a Single Tumor Necrosis Factor (TNF) Inhibitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24
研究概览
简要总结
This observational study will assess the long-term efficacy and safety of MabThera/Rituxan in routine clinical practice in patients with sero-positive rheumatoid arthritis who are non-responders or intolerant to a single tumour necrosis factor (TNF) inhibitor. Data will be collected from each patient over 2 years.
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
- •Rheumatoid arthritis positive for rheumatoid factor and/or anti-CCP
- •Non-responder or intolerant to single TNF-inhibitor therapy
- •Initiating treatment with MabThera/Rituxan
排除标准
- •Contra-indications to MabThera/Rituxan therapy
结局指标
主要结局
Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24
时间窗: Baseline (Day 0) and Month 24
The disease-activity score 28 (DAS28) score is a measure of validated instrument for the assessment of the overall severity of RA disease activity calculated using the tender joint count (TJC), swollen joint count (SJC), patient's global assessment of disease activity, and erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
次要结局
- Mean Change From Baseline in Patient's Global Assessment of Disease Activity at Month 24(Baseline (Day 0) and Month 24)
- Mean Change From Baseline in SJC at Month 24(Baseline (Day 0) and Month 24)
- Mean Change From Baseline in Physician's Global Assessment of Disease Activity At Month 24(Baseline (Day 0) and Month 24)
- Mean Change Form Baseline in Functional Capacity at Month 24(Baseline (Day 0) and Month 24)
- Number of Participants With Incidence of Infectious Events(At Months 6, 12 and 24)
- Mean Change From Baseline in TJC at Month 24(Baseline (Day 0) and Month 24)
- Mean Change From Baseline in ESR at Month 24(Baseline (Day 0) and Month 24)
- Mean Change From Baseline in C-reactive Protein at Month 24(Baseline (Day 0) and Month 24)
- Mean Change From Baseline in Severity of Pain at Month 24(Baseline (Day 0) and Month 24)
- Number of Participants With Incidence of Infusion Reactions or Injection Site Reactions(At Months 6, 12 and 24)
- Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events(Up to Month 24)
- Reason for Change From First TNF-inhibitor Therapy to Rituximab(At Screening)
- Number of Participants on Each Pattern of Re-treatment(Up to Month 24)