NCT03491904已完成1 期
A Phase 1, Multicenter, Randomized, Open-Label, Parallel-Group, Multi-Dose Study in Patients With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee or Hip to Assess the Patients' Ability to Self-Administer Fasinumab Using an Auto-Injector and to Characterize the Pharmacokinetics of Fasinumab Using Two Different Presentations
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of device-associated product technical failure (PTF) for the AI based on the total number of fasinumab injections administered by patients/caregivers in an unsupervised setting
研究概览
简要总结
The primary objective is to demonstrate that the auto-injector(AI) is suitable to be used to administer fasinumab at home by patients or their caregivers, as measured by collecting 12 weeks of actual-use data on the technical performance of the device.
The secondary objectives of the study are:
- To evaluate the successful injection of fasinumab by patients or their caregivers using the AI in an unsupervised setting
- To evaluate patient/caregiver satisfaction with the AI for fasinumab injection in an unsupervised setting
- To evaluate exposure in serum for fasinumab administered by patients or their caregivers using an AI in an unsupervised setting, or fasinumab administered by study staff using a PFS that has been used in the phase 3 program
- To characterize the safety, tolerability, and immunogenicity of fasinumab administered by patients or their caregivers using an AI in an unsupervised setting, or fasinumab administered by study staff using a PFS that has been used in the phase 3 program
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
- None
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 Osteoarthritis (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 at least 12 weeks of analgesic use for pain due to OA of the knee or hip
- •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 NSAIDs, selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations thereof
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 of 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
- •Signs or symptoms of carpal tunnel syndrome within 6 months of screening
- •Patient is not a candidate for MRI
- •Note: Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Auto-injector (AI)
Experimental
干预措施: Fasinumab AI (Drug)
Prefilled syringe (PFS)
Experimental
干预措施: Fasinumab PFS (Drug)
结局指标
主要结局
Percentage of device-associated product technical failure (PTF) for the AI based on the total number of fasinumab injections administered by patients/caregivers in an unsupervised setting
时间窗: Baseline to Week 16
次要结局
- Proportion of successful fasinumab injections administered by patients or their caregivers using an AI in an unsupervised setting (per patient report)(Baseline to Week 16)
- Number of AI associated product technical complaint (PTCs)(Baseline to Week 16)
- Number of validated AI associated PTFs(Baseline to Week 16)
- Number of patients with an AI associated PTC(Baseline to Week 16)
- Number of AI use-related errors(Baseline to Week 16)
- Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)(Baseline to Week 16)
- Number of participants who experience Adjudicated arthropathy (AA)(Through week 36)
- Number of participants who experience Destructive arthropathy (DA)(Through week 36)
- Number of participants who experience treatment-emergent adverse events (TEAEs)(Through week 16)
- Number of participants who experience sympathetic nervous system dysfunction(Through week 36)
- Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation(Through week 36)
- Number of participants who experience all-cause Joint replacement (JR)s(Through week 36)
- Number of participants who experienced JR at the telephone survey(52 weeks after last dose of study drug)
- Maximum observed drug concentration (Cmax)(Up to 36 weeks)
- Area under the curve from the time of dosing to the end of dosing interval (AUC)(Up to 36 weeks)
- Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio(Up to 36 weeks)
- Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio(Up to 36 weeks)
- Incidence of anti-drug antibody (ADA)(Up to 36 weeks)
研究者
研究点 (1)
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