Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate<br>the Efficacy, Safety, and Tolerability of Fulranumab as Monotherapy in Subjects with<br>Signs and Symptoms of Osteoarthritis of the Hip or Knee - 42160443PAI3003: Fulranumab study in osteoarthritis patients

Janssen-Cilag0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•The major inclusion criteria are:
•1) Man or woman at least 18 years of age;
•2) Clinical diagnosis of 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;
•3) Scheduled joint replacement surgery for the study joint *20 weeks after randomization or planning to undergo a joint replacement surgery for the study joint;
•4) Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes at least one from each of the following 3 classes of oral analgesic medications (acetaminophen/paracetamol, NSAID, and opioid;
•5) Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA with specific criteria applied to each scale and subscale. Eligibility criteria will be blinded to subjects, investigators, and site staff to reduce error variance, to improve accuracy of treatment estimates, and to avoid inclusion of subjects who cannot provide interpretable data.
•6) 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;
•Please refer to the protocol section 4.1 ( page 42-44) for a complete list of inclusion criteria)

•The major exclusion criteria are medical history that suggests:
•1) Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA);
•2) Sympathetic dysfunction as defined in the protocol
•3)Central nervous system abnormalities as defined in the protocol
•4) Peripheral neurological deficits as defined in the protocol
•5)Viral infections as defined in the protocol
•6)Cardiovascular related conditions as defined in the protocol
•7) History of inherited disorders associated with or causing hypercoagulopathy
•8) History of malignanies within the past 2 years
•9)Uncontrolled diabetes
•10) any other chronic pain condition that would interfere with the subject's ability to assess their OA pain ( e.g fibromyalgia)
•11) Creatinine clearance < 30 mL per minute
•12) ALT or AST>- 2.5 times ULN
•13) BMI > 39 kg/m2
•14) Other as described in the protocol;Please see a complete list of all exclusion criteria in the protocol section 4.2 (page 44-47)

发起方