Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Monotherapy in Subjects With Signs and Symptoms of Osteoarthritis of the Hip or Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.
详细描述
This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance is given to one group of participants while active drug is given to another group of participants to see if there is a difference in response), parallel-group (study drugs given to participants in all treatment groups during the same time period) to evaluate the efficacy (capacity of the investigational drug to produce an effect), safety, and tolerability of fulranumab administered as monotherapy (alone; not in combination with other drug therapy) to participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain therapy. The duration of participation in the study for an individual participant will be up to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16 weeks, and a post-treatment follow-up period of up to 48 weeks).). All participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab 3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up to 16 weeks. Blood samples will be collected from each participant at time points during the study. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests and vital signs which will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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, NSAID, and an opioid); For participants in the USA and Canada: Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids other than codeine or codeine combination products)
- •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
排除标准
- •Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
- •Unstable or progressive neurologic disorders
研究组 & 干预措施
Placebo
Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of placebo during the double-blind treatment phase.
干预措施: Placebo (Drug)
Fulranumab 1 mg
Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 1 mg during the double-blind treatment phase.
干预措施: Fulranumab 1 mg (Drug)
Fulranumab 3 mg
Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 3 mg during the double-blind treatment phase.
干预措施: Fulranumab 3 mg (Drug)
结局指标
主要结局
Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score
时间窗: Baseline, Week 16
The WOMAC 3.1 is a multi-dimensional, osteoarthritis (OA) specific self-administered questionnaire using 24 questions with a 48-hour recall that are grouped into 3 subscales (pain, stiffness, and physical function) associated with hip or knee OA. Pain, stiffness, and physical function is rated on a scale of 0-10 (0 = less severe up to 10 = more severe).
Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score
时间窗: Baseline, Week 16
See WOMAC 3.1 described above.
Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score
时间窗: Baseline, Week 16
The PGA is part of a comprehensive assessment of the impact of treatment for osteoarthritis that also includes pain and physical function. The PGA included in the present study indicates the perception of osteoarthritis in the study joint at the current time. Ratings are provided on an 11-point numerical rating scale from 0 ("Very Good") to 10 ("Very Bad").
次要结局
- Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score(Baseline, Week 16)
- Change from baseline to the end of Week 16 in WOMAC Stiffness subscale score(Baseline, Week 16)
- Change from baseline to the end of Week 16 in daily numerical rating scale (NRS) score(Baseline, Week 16)
- Change from baseline to the end of Week 16 in Medical Outcomes Study (MOS) Sleep subscale scores(Baseline, Week 16)
- Change from baseline to the end of Week 16 in Short-Form--36 (SF-36) subscale scores(Baseline, Week 16)
- Change from baseline to the end of Week 16 in EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) scale score(Baseline, Week 16)
- Change from baseline to the end of Week 16 in the percentage of participants who are responders based on WOMAC pain and physical function subscale scores and PGA scale scores(Baseline, Week 16)
- Change from baseline to the end of Week 16 in the percentage of participants who are responders based on OMERACT-OARSI, MCII, and PASS scale scores(Baseline, Week 16)
- Change from baseline to the end of Week 16 in the percentage of participants who use rescue medication and other osteoarthritis (OA) analgesia(Baseline, Week 16)