Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee

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追踪信息

首次提交日期 ^ICMJE

September 12, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

October 8, 2018

预计主要完成日期

September 27, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Change in peroneal motor nerve conduction velocity[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in peroneal motor nerve action potential amplitude[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in sural sensory nerve conduction velocity[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in sural sensory nerve action potential amplitude[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in ulnar sensory nerve conduction velocity[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in ulnar sensory nerve action potential amplitude[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score[ Time Frame: Baseline to week 16 ]
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
Change in WOMAC physical function subscale score[ Time Frame: Baseline to week 16 ]
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
Incidence of Adjudicated arthropathy (AA)[ Time Frame: Week 16 ]
As confirmed by an independent adjudication committee
Incidence of Adjudicated arthropathy (AA)[ Time Frame: Week 36 ]
As confirmed by an independent adjudication committee
Incidence of Destructive arthropathy (DA)[ Time Frame: Week 16 ]
As confirmed by an independent adjudication committee
Incidence of Destructive arthropathy (DA)[ Time Frame: Week 36 ]
As confirmed by an independent adjudication committee
Incidence of treatment-emergent adverse event (TEAEs)[ Time Frame: Up to 64 weeks ]
Incidence of Sympathetic Nervous System (SNS) dysfunction[ Time Frame: Up to 36 weeks ]
As diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist
Incidence of peripheral sensory Adverse Events (AEs) that require a neurology consultation[ Time Frame: Up to 64 weeks ]
Incidence of all-cause joint replacement (JR) surgeries[ Time Frame: Week 16 ]
Incidence of all-cause JR surgeries[ Time Frame: Week 36 ]
Incidence of JRs at telephone survey[ Time Frame: 52 weeks after last dose of study drug ]

描述性信息

简略标题 ^ICMJE

Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee

正式标题 ^ICMJE

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

简要概况

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.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Fasinumab
Subcutaneous (SC) every four weeks (Q4W)
Other: Placebo
Subcutaneous (SC) every four weeks (Q4W)

研究工具

Experimental: Fasinumab
Placebo Comparator: Placebo

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

180

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

August 28, 2020

预计主要完成日期

September 27, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Key Inclusion Criteria: 1. 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 2. 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 3. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments 4. 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 5. 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 Key Exclusion Criteria: 1. 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 2. 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 3. Trauma to the index joint within 3 months prior to the screening visit 4. History or presence of signs or symptoms of compression neuropathy, including carpal tunnel syndrome or sciatica 5. Participant is not a candidate for Magnetic Resonance Imaging (MRI) 6. Poorly controlled diabetes 7. Known history of human immunodeficiency virus (HIV) infection 8. Known history of ocular herpes simplex virus, herpes simplex virus pneumonia, or herpes simplex virus encephalitis 9. History of poorly controlled hypertension 10. Known history of infection with hepatitis B or C virus Note: Other protocol defined Inclusion/Exclusion apply

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Regeneron Pharmaceuticals

合作者 ^ICMJE

研究员 ^ICMJE

Study Director: Clinical Trial Management Regeneron Pharmaceuticals

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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