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

Janssen-Cilag International NV0 个研究点目标入组 450 人开始时间: 2015年7月23日最近更新: 2017年7月24日

适应症

试验速览

暂无简介。

•-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

•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.

发起方