EUCTR2013-001830-16-PL进行中（未招募）1 期
Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Adjunctive Therapy in Subjects with Signs and Symptoms of Osteoarthritis of the Hip or Knee
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •-Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class =2) of the study joint
- •- Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint
- •- Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids) and receiving an opioid at study entry
- •- Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA
- •-During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •The major exclusion criteria are medical history that suggests:
- •1) Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA);
- •2) Unstable or progressive neurologic disorders.
研究者
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