jRCT2080220736未知3 期
Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 主要终点
- ACR criteria
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open-labelled, multicenter study
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subjects who have completed the week 24 visit in the previous study
- •Treatment with methotrexate (MTX) 6-8mg/week (administered orally) has continued from the previous study.
排除标准
- •Functional Class 4 as defined by the ACR Classification of Functional Status in rheumatoid arthritis.
- •Cardiac or pulmonary function worsens markedly from the week 24 visit in the previous study to enrolment in this study.
- •Primary or secondary immunodeficiency, including HIV infection occurs from the week 24 visit in the previous study to enrolment in this study.
- •Hepatitis B, hepatitis C or tuberculosis infection occurs from the week 24 visit in the previous study to enrolment in this study.
- •Malignancy occurs from the week 24 visit in the previous study to enrolment in this study.
结局指标
主要结局
ACR criteria
the frequency of achievement of 20%, 50% and 70% in terms of the ACR criteria
DAS28
the frequency of achievement of 20%, 50% and 70% in terms of the DAS28
EULAR response rate
the frequency of achievement of 20%, 50% and 70% in terms of the EULAR response rate
HAQ-DI score
the frequency of achievement of 20%, 50% and 70% in terms of the HAQ-DI score
FACIT-Fatigue scale
the frequency of achievement of 20%, 50% and 70% in terms of the FACIT-Fatigue scale
persistence rate
the frequency of achievement of 20%, 50% and 70% in terms of the persistence rate
incidence of adverse events
Safety (incidence of adverse events)
Changes of endpoints
Changes of endpoints from the beginning of the treatment in the previous study
次要结局
未报告次要终点
研究者
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