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

Hexal AG0 个研究点目标入组 546 人开始时间: 2013年4月15日最近更新: 2015年7月10日

适应症

试验速览

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•Patients must be able to understand and communicate with the investigator and comply with the requirements of the study [including administration of subcutaneous (s.c.) injections at home] and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations
•Men or women at least 18 years of age at time of screening
•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,
•IGA score of 3 or greater (based on a scale of 0 - 4) and,
•BSA 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 440
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 106

•Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis)
•Drug-induced psoriasis (i.e., new onset or current exacerbation from e.g. beta-blockers, or lithium)
•Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV-therapy). Washout periods detailed in the protocol have to be adhered to
•Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least four weeks before baseline
•Previous exposure to etanercept

发起方