NCT02600468已完成不适用
Outline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg
Bristol-Myers Squibb0 个研究点目标入组 671 人开始时间: 2013年9月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 671
- 主要终点
- Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events
研究概览
简要总结
The purpose of this study to collect information on the safety, especially serious infections and malignancies, and efficacy of the long-term use of ORENCIA Intravenous Infusion 250mg in patients with rheumatoid arthritis.
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
- •Patients who are beginning to receive the treatment with ORENCIA Intravenous Infusion 250mg under the approved indications, dosage, and administration
- •Have available HAQ data
- •Have available DAS28-ESR or DAS28- CRP data
- •Have no past or present history of malignancies
- •Are expected to be followed up for 3 years
排除标准
- 未提供
研究组 & 干预措施
Patients who use ORENCIA
Patients who use ORENCIA for the approved indications and who at the start of treatment
干预措施: Orencia (Drug)
结局指标
主要结局
Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events
时间窗: 3 years
次要结局
- Efficacy measured by Patient's survival(3 years)
- Efficacy measured by development of malignancies after treatment discontinuation(3 years)
研究者
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