A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change From Baseline in Peroneal Motor Nerve Action Potential Amplitude at Week 16
研究概览
简要总结
The primary objective of the study is to evaluate the effect of fasinumab compared to placebo on peripheral nerves in participants with pain due to Osteoarthritis (OA) of the hip or knee.
The secondary objectives of the study are to:
- Evaluate the efficacy of fasinumab compared to placebo in participants with pain due to OA of the hip or knee
- Evaluate the safety and tolerability of fasinumab compared to placebo in participants with pain due to OA of the hip or knee
- Characterize the concentrations of fasinumab in serum in participants with pain due to OA of the hip or knee
- Evaluate the immunogenicity of fasinumab in participants with pain due to OA of the hip or knee.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit
- •Moderate-to-severe pain in the index joint defined as a WOMAC average pain subscale score of ≥4 at both the screening and randomization visits
- •Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments
- •A history of regular use of analgesic medications for OA pain (defined as an average of 4 days per week over the 4 weeks prior to the screening visit), including oral nonsteroidal anti-inflammatory drugs (NSAIDs), selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations thereof
- •Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere prior to and during the study period to be shared with the investigator
排除标准
- •History or presence at the screening visit of non-OA inflammatory joint disease (eg, rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout, spondyloarthropathy, polymyalgia rheumatica, joint infections within the past 5 years), Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
- •History or presence on imaging of arthropathy (osteonecrosis, subchondral insufficiency fracture, rapidly progressive OA type 1 or type 2), stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation (prosthetic hip dislocation is eligible), knee dislocation (patella dislocation is eligible), congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures during the screening period
- •Trauma to the index joint within 3 months prior to the screening visit
- •History or presence of signs or symptoms of compression neuropathy, including carpal tunnel syndrome or sciatica
- •Participant is not a candidate for Magnetic Resonance Imaging (MRI)
- •Poorly controlled diabetes
- •Known history of human immunodeficiency virus (HIV) infection
- •Known history of ocular herpes simplex virus, herpes simplex virus pneumonia, or herpes simplex virus encephalitis
- •History of poorly controlled hypertension
- •Known history of infection with hepatitis B or C virus
- •Note: Other protocol defined Inclusion/Exclusion apply
研究组 & 干预措施
Fasinumab
干预措施: Fasinumab (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Peroneal Motor Nerve Action Potential Amplitude at Week 16
时间窗: Baseline, Week 16
Peroneal motor nerve action potential amplitude was evaluated at ankle by electrical stimulation of the nerve and recorded the compound muscle action potential from surface electrodes overlying a muscle supplied by the nerve. Change from baseline in peroneal motor nerve action potential amplitude at Week 16 was reported.
Change From Baseline in Sural Sensory Nerve Action Potential Amplitude at Week 16
时间窗: Baseline, Week 16
Sural sensory nerve action potential amplitude was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline in sural sensory nerve action potential amplitude at Week 16 was reported.
Change From Baseline in Ulnar Sensory Nerve Conduction Velocity at Week 16
时间窗: Baseline, Week 16
Ulnar sensory nerve conduction velocity was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline in ulnar sensory nerve conduction velocity at Week 16 was reported.
Change From Baseline in Ulnar Sensory Nerve Action Potential Amplitude at Week 16
时间窗: Baseline, Week 16
Ulnar sensory nerve action potential amplitude was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline ulnar sensory nerve action potential amplitude at Week 16 was reported.
Change From Baseline in Peroneal Motor Nerve Conduction Velocity at Week 16
时间窗: Baseline, Week 16
Peroneal motor nerve conduction velocity was evaluated by electrical stimulation of the nerve and recorded the compound muscle action potential from surface electrodes overlying a muscle supplied by the nerve. Change from baseline in peroneal motor nerve conduction velocity at Week 16 was reported.
Change From Baseline in Sural Sensory Nerve Conduction Velocity at Week 16
时间窗: Baseline, Week 16
Sural sensory nerve conduction velocity was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline in sural sensory nerve conduction velocity at Week 16 was reported.
次要结局
- Number of Sympathetic Nervous System (SNS) Dysfunction Events(Baseline up to follow-up (Week 36))
- Serum Concentration of Functional Fasinumab(Baseline, Week 1, 2, 4, 8, 12, 16 and 36)
- Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug(Baseline up to EOS (Week 64))
- Number of Participants With At-least One Positive Anti-Drug Antibody (ADA)(Baseline up to follow-up period (Week 36))
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16(Baseline, Week 16)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Baseline up to Week 16)
- Number of Adjudicated Arthropathy (AA) Events(Baseline up to follow-up (Week 36))
- Number of AA Events Meeting Destructive Arthropathy (DA) Criteria(Baseline up to follow-up (Week 36))
- Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation(Baseline up to follow-up (Week 36))
- Change From Baseline in WOMAC Physical Function Subscale Score at Week 16(Baseline, Week 16)
- Number of All-Cause Joint Replacement (JR) Surgery Events(Baseline up to follow-up (Week 36))