DRKS00005365已完成3 期
A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar etanercept (GP2015) and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis - EGALITY
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Hexal AG
- 入组人数
- 531
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Chronic plaque-type psoriasis diagnosed for at least 6 months before baseline
- •Moderate to severe psoriasis as defined at baseline by:
- •?PASI score of 10 or greater and,
- •?Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,
- •?Body Surface Area affected by plaque-type psoriasis of 10% or greater
- •Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.
- •Other Inclusion criteria may apply
排除标准
- •Forms of psoriasis other than chronic plaque-type
- •Drug-induced psoriasis
- •Ongoing use of prohibited treatments
- •Previous exposure to etanercept
- •Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept
- •Other exclusion criteria may apply
研究者
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