A Phase 3, Multicenter Study with a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period from Week 36 to Week 104 to Evaluate the Long Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug–Naive Patients with Active Psoriatic Arthritis

Eli Lilly and Company0 个研究点目标入组 400 人开始时间: 2015年10月1日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•Patients are eligible to be included in the study only if they meet all of the following criteria:
•[1] are male or female patients 18 years or older who agree to use reliable method of birth control or remain abstinent during the study
•[2] have had diagnosis of active PsA for at least 6 months and meet Classification for Psoriatic Arthritis (CASPAR) criteria
•[3] active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
•[4] have been treated with 1 or more conventional disease-modifying antirheumatic drugs (DMARDs)
•[5] have active psoriatic skin lesions (plaque) or a documented history of plaque psoriasis
•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 380
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Patients will be excluded from study enrollment if they meet any of the following criteria:
•[7] have received any previous treatment or are currently receiving treatment with any biologic or small-molecule therapy for PsA or psoriasis
•[10] have had, in the opinion of the investigator, inadequate response to treatment with =4 cDMARDs or immune modifiers
•[12] are receiving treatment with more than 1 cDMARD
•[20] have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study
•[24] have a diagnosis of other inflammatory arthritic syndromes such as RA, ankylosing spondylitis, reactive arthritis, or enteropathic arthritis
•[33] have serious disorder other than psoriatic arthritis
•[36] had a serious infection within 12 weeks
•[43] are positive for human immunodeficiency virus serology
•[44] have evidence of or test positive for hepatitis B or hepatitis C virus
•[50] are women who are lactating or breastfeeding

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