NCT00646386已完成2 期
Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 315
- 主要终点
- ACR20
研究概览
简要总结
Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Moderate to severe PsA
- •Inadequate response to DMARD therapy
- •Corticosteroid stable dose <= 10 mg QD
- •DMARDs must have been taken for 3 months and stable dose for 4 weeks
- •MTX maximum dose = <= 30 mg/week
- •Active chronic plaque PS or documented history of chronic plaque PS
排除标准
- •No other active skin disease
研究组 & 干预措施
A
Active Comparator
干预措施: adalimumab (Drug)
B
Placebo Comparator
干预措施: placebo for adalimumab (Drug)
结局指标
主要结局
ACR20
时间窗: Week 12
Adverse Events
时间窗: Throughout study participation
Sharp Score
时间窗: Week 24
次要结局
- ACR20, 50, 70(Weeks 12, 24)
- Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI(Weeks 12 and 24)
研究者
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