NCT00645892已完成2 期
Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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
- 32
- 主要终点
- Psoriasis Area and Severity Index
研究概览
简要总结
Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
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
- •Subject participated and relapsed in prior PS study
排除标准
- •Subject has other active skin diseases
- •Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
- •Poorly controlled medical conditions
- •History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
- •History of cancer or lymphoproliferative disease
- •History of active TB or listeriosis, or persistent chronic or active infections
- •Known to have immune deficiency or is immunocompromised
- •Clinically significant abnormal laboratory test results
- •Erythrodermic psoriasis or generalized pustular psoriasis
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
Psoriasis Area and Severity Index
时间窗: Week 12
Adverse Events
时间窗: Throughout Study Participation
次要结局
- Psoriasis Area and Severity Index(Week 12, Week 24)
- Physician's Global Assessment(Week 12, Week 24)
研究者
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