NCT01583244已完成不适用
Korean Post-marketing Surveillance for Orencia®
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 701 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 701
- 试验地点
- 1
- 主要终点
- Adverse events occurrence
研究概览
简要总结
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly.
详细描述
Time Perspective: Prospective / Retrospective(On-treatment)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be diagnosed with: Adult Rheumatoid arthritis (RA): adult patients with moderate-to-severe active RA
- •Juvenile idiopathic RA: juvenile patients aged 6 years and older with moderate-to-severe active RA
排除标准
- •Children aged <6 years
- •Pregnant or lactating women
- •Patients who are participating in another study
- •Patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug
- •Patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study
- •Patients who have a positive hepatitis virus test
- •Patients who were given a live vaccine concurrently with the surveillance drug or are expected to be given a live vaccine again within 3 months after discontinuation of the surveillance drug
研究组 & 干预措施
Patients with active rheumatoid arthritis
Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis
干预措施: No Intervention (subjects were previously treated with Orencia®) (Drug)
结局指标
主要结局
Adverse events occurrence
时间窗: 30 days after last dose of study drug
次要结局
- Number of Adverse Events and Serious Adverse Events(30 days after last dose of study drug)
- Efficacy of Orencia® measured by swollen joint counts and tender joint counts in the subject treated with the surveillance drug, patient-assessed pain, APR, patient-assessed global health, physician-assessed global disease activity(24 weeks of registration)
研究者
研究点 (1)
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