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临床试验/NCT00443443
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)

Genentech, Inc.165 个研究点 分布在 1 个国家目标入组 1,026 人开始时间: 2007年1月最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (165)

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