Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Fulranumab as Adjunctive Therapy in Subjects with Signs and Symptoms of Osteoarthritis of the Hip or Knee

Janssen-Cilag International N.V.0 个研究点目标入组 643 人开始时间: 2015年3月11日最近更新: 2016年10月10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
•- Unsatisfactory response (inadequate efficacy or poor tolerability) on standard of care that includes 3 of any of the following classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, or opioid)
•- 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 600
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•-Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
•-Unstable or progressive neurologic disorders

发起方