NCT02564770已完成不适用
A Retrospective Chart Review of the Use of MabThera (Rituximab) for the Treatment of Rheumatoid Arthritis (RA) in Australian Rheumatology Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 主要终点
- Factors leading to Therapeutic decision to use rituximab
研究概览
简要总结
This is a cross-sectional, observational study examining the factors leading to the therapeutic decision to use MabThera (rituximab) in participants with RA. Routine rheumatology clinical practice data of participants who are being or have been treated with rituximab for RA will be collected and analysed in this chart review.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Greater than or equal to (>=) 18 years of age at the time of data collection
- •RA diagnosed by a rheumatologist
- •Treatment with rituximab for RA
排除标准
- •Participants whose primary diagnosis and indication for rituximab treatment is a condition other than RA
- •Participants who have been treated with an experimental agent for RA which is not currently approved for the treatment of RA in Australia
结局指标
主要结局
Factors leading to Therapeutic decision to use rituximab
时间窗: Up to end of study (approximately 1 month)
次要结局
- Disease activity score (DAS28)(At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month))
- Change in C-reactive protein(Baseline and most recent visits (approximately 1 month))
- Percentage of participants with positive or negative results for rheumatoid factor(Up to end of study (approximately 1 month))
- Change in Erythrocyte sedimentation rate(Baseline and most recent visits (approximately 1 month))
- Change in Immunoglobulin levels(Baseline and most recent visits (approximately 1 month))
- Swollen joint count (SJC)(At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month))
- Duration of treatment with rituximab(From first dose to most recent rituximab infusion (approximately 1 month))
- Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody(Up to end of study (approximately 1 month))
- Percentage of participants with positive or negative results for anti-nuclear antibodies(Up to end of study (approximately 1 month))
- Tender joint count (TJC)(At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month))
研究者
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