NCT00443443已完成不适用
A Long-Term Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,026
- 试验地点
- 165
研究概览
简要总结
This is an observational study designed to follow patients with RA who have had an inadequate response to one or more anti-TNF therapies and who will receive Rituxan. Approximately 1000 patients in the United States with RA who have had an inadequate response to anti-TNF therapies and who will receive Rituxan therapy will be recruited. There is no protocol mandated treatment assignment in this study. Patients will be evaluated and treated according to their physician's standard practice and discretion.
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
- •No prior use of Rituxan (except if received within 8 weeks of screening)
- •Signed Informed Consent Form
- •Age ≥ 18 years
- •Diagnosis of RA
- •Inadequate response to one or more anti-TNF therapies
排除标准
- •Have known hypersensitivity to any component of a humanized or murine monoclonal antibody
研究者
研究点 (165)
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