EUCTR2011-004016-29-DE进行中（未招募）不适用
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging, Multi-Center Study to Evaluate the Efficacy and Safety of Clazakizumab Subcutaneous Injection in Adults with Active Psoriatic ArthritisRevised Protocol 03, incorporating Amendment 05Pharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 13-Sep-2011)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 224
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
- 性别
- All
入选标准
- •Must be on a stable background methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose = 15 mg to a maximum weekly dose of = 25 mg, and be at a stable dose for 4 weeks prior to enrollment. Methotrexate dose = 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed.
- •Inadequate response to NSAID or non-biologic DMARD
- •Minimum of 3 swollen and 3 tender joints
- •Active psoriatic skin lesions over minimum 3% body surface area
- •hsCRP = 0.3 mg/dL
- •Subjects must have diagnosis of active PsA by Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 12 weeks prior to screening
- •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 213
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •Previously received or currently receiving concomitant biologic therapy
研究者
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