EUCTR2011-002328-42-CZ进行中（未招募）1 期
Protocol I1F-MC-RHBE A Multicenter, Randomized, Double-Blind, Placebo-Controlled 24-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients with Active Psoriatic Arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Presents with established diagnosis of active psoriatic arthritis (PSA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- •Active psoriatic arthritis defined as the presence of at least 3 tender and at least 3 swollen joints
- •Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
- •Men must agree to use a reliable method of birth control or remain abstinent during the study
- •Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- •Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
- •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 342
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Current use of biologic agents for treatment of Ps or PsA
- •Inadequate response to greater than 2 bDMARDs
- •Current use of more than one cDMARD
- •Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
- •Have received treatment with IL-17 or IL12/23 targeted MAb therapy
- •Serious disorder or illness other than psoriatic arthritis
- •Serious infection within the last 3 months
- •Breastfeeding or nursing (lactating) women
研究者
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