NCT00195689已完成3 期
A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis
Abbott1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2003年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- HAQ
研究概览
简要总结
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject completed study M02-518 or M02-570
排除标准
- •Subject prematurely discontinued study M02-518 or M02-570
- •Female subject who is pregnant or breast-feeding or considering becoming pregnant
- •Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
研究组 & 干预措施
未命名试验
干预措施: Human anti-TNF monoclonal antibody/adalimumab (Biological)
结局指标
主要结局
HAQ
Safety parameters
ACR 20/50/70
PsARC
SF-36
Disease progression measurements
FACTIT Fatigue Scale
次要结局
- Clinical response indicators
- Patient reported outcomes
研究者
研究点 (1)
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