A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar adalimumab (GP2017) and Humira® in patients with moderate to severe chronic plaque-type psoriasis.
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 448
- 试验地点
- 9
- 主要终点
- The primary outcome measure is the PASI 75 response rate.
研究概览
简要总结
i] Purpose of the Trial - The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.ii] FPFV for India -17th March, 2014.
iii] Target Sample Size for India - 100
iv] Reason for withdrawal: Reason for Withdrawal of Trial: The Sponsor of the study (Sandoz) decided to withdraw the study from India due to administrative reasons.Enrollment did not start in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •>> Men or women at least 18 years of age at time of screening >> Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization >> Moderate to severe psoriasis as defined at baseline by: >> PASI score of 12 or greater >> Investigator´s Global Assessment score of 3 or greater (based on a scale of
- •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.
排除标准
- •Forms of psoriasis other than chronic plaque-type
- •Drug-induced psoriasis
- •Ongoing use of prohibited psoriasis treatments
- •Previous exposure to adalimumab
- •Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept.
结局指标
主要结局
The primary outcome measure is the PASI 75 response rate.
时间窗: The primary outcome measure is the PASI 75 response rate. | [Designated as safety issue: No]
[Designated as safety issue: No]
时间窗: The primary outcome measure is the PASI 75 response rate. | [Designated as safety issue: No]
次要结局
- 2. Change from baseline in IGA([Designated as safety issue: No])
- 3. Patient health related quality of life (HRQoL)([Designated as safety issue: No])
- 1. PASI response rates([Designated as safety issue: No])