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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Safety parameters
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
结局指标
主要结局
Safety parameters
ACR 20/50/70
PsARC
HAQ
SF-36
Disease progression measurements
FACTIT Fatigue Scale
次要结局
- Clinical response indicators
- Patient reported outcomes
研究者
研究点 (2)
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