A PHASE 1/2A, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND, DOSE-ESCALATION, MULTICENTER STUDY OF THE SAFETY, TOLERABILITY, EFFICACY AND PHARMACOKINETICS, OF A SINGLE INTRAVENOUS DOSE OF PF-04383119 IN JAPANESE PATIENTS WITH MODERATE TO SEVERE PAIN FROM OSTEOARTHRITIS OF THE KNEE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 83
- 试验地点
- 12
- 主要终点
- Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5
研究概览
简要总结
To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee (Part I). To evaluate the preliminary analgesic efficacy of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee in comparison with placebo (Part I and Part II).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese Male or female, Age 35-65 (Part 1), Age 35-75 (Part 2)
- •Diagnosis of osteoarthritis (OA) of the knee based on American College of Rheumatology criteria
- •Knee pain, and radiographic evidence of knee OA (Kellgren-Lawrence x-ray grade ≥2) obtained within 1 year of enrollment
- •At least one of the following: age >50, morning stiffness <30 minutes in duration, crepitus, and OA of the knee must involve the index tibiofemoral joint and must have present for at least 6 months
- •Patients who meet at least one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery
- •Pain levels as required by the protocol at Screening and Baseline
排除标准
- •Diagnosis or history of RA, any inflammatory arthritis, gout, Paget's disease or any other disease that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of OA
- •Patients with regional pain syndromes suggestive of fibromyalgia or regional pain caused by lumbar or cervical compressions with radiculopathy or at risk of developing radiculopathy.
- •Diagnosis or history of fibromyalgia
- •Planned surgical procedure during the duration of the study
研究组 & 干预措施
10 mcg/kg
干预措施: PF-04383119 (tanezumab) (Drug)
100 mcg/kg
干预措施: PF-04383119 (tanezumab) (Drug)
200 mcg/kg
干预措施: PF-04383119 (tanezumab) (Drug)
25 mcg/kg
干预措施: PF-04383119 (tanezumab) (Drug)
50 mcg/kg
干预措施: PF-04383119 (tanezumab) (Drug)
Placebo
干预措施: PF-04383119 (tanezumab) (Drug)
结局指标
主要结局
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5
时间窗: Day 4/5 (Part 1 and 2)
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9
时间窗: Baseline, Week 9 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17
时间窗: Week 17 (Part 1 and Part 2)
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2
时间窗: Baseline, Week 2 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7
时间窗: Baseline, Week 7 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 10 0= extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12
时间窗: Baseline, Week 12 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline
时间窗: Baseline (Part 1 and Part 2)
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1
时间窗: Day 1 (Part 1 and 2)
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1
时间窗: Week 1 (Part 1 and Part 2)
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3
时间窗: Week 3 (Part 1 and 2)
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13
时间窗: Week 13 (Part 1 and Part 2)
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Day 1 up to Day 92 for tanezumab 10, 25, 50 mcg/kg group and matching placebo group (Part 1, 2); Day 1 up to Day 120 for tanezumab 100 mcg/kg group and matching placebo group (Part 1, 2), 200 mcg/kg group and matching placebo group (Part 1)
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent: events between first dose of study drug and up to Day 1 through Day 120 (Part 1 and 2) were absent before treatment or that worsened relative to pretreatment state
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3
时间窗: Baseline, Week 3 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4
时间窗: Baseline, Week 4 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5
时间窗: Baseline, Week 5 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11
时间窗: Baseline, Week 11 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1
时间窗: Baseline, Week 1 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2
时间窗: Week 2 (Part 1 and Part 2)
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4
时间窗: Week 4 (Part 1 and Part 2)
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1
时间窗: Baseline, Week 1 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6
时间窗: Baseline, Week 6 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13
时间窗: Baseline, Week 13 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5
时间窗: Baseline, Week 5 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10
时间窗: Baseline, Week 10 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2
时间窗: Baseline, Week 2 (Part 1 and 2)
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8
时间窗: Baseline, Week 8 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6
时间窗: Baseline, Week 6 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11
时间窗: Baseline, Week 11 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7
时间窗: Baseline, Week 7 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8
时间窗: Baseline, Week 8 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9
时间窗: Baseline, Week 9 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13
时间窗: Baseline, Week 13 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10
时间窗: Baseline, Week 10 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2
时间窗: Baseline, Week 2 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7
时间窗: Baseline, Week 7 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10
时间窗: Baseline, Week 10 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11
时间窗: Baseline, Week 11 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3
时间窗: Baseline, Week 3 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9
时间窗: Baseline, Week 9 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12
时间窗: Baseline, Week 12 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1
时间窗: Baseline, Week 1 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2
时间窗: Baseline, Week 2 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4
时间窗: Baseline, Week 4 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6
时间窗: Baseline, Week 6 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12
时间窗: Baseline, Week 12 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4
时间窗: Baseline, Week 4 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5
时间窗: Baseline, Week 5 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8
时间窗: Baseline, Week 8 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13
时间窗: Baseline, Week 13 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3
时间窗: Baseline, Week 3 (Part 1 and 2)
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4
时间窗: Baseline, Week 4 (Part 1 and 2)
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17
时间窗: Baseline, Week 17 (Part 1 and 2)
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1
时间窗: Baseline, Week 1 (Part 1 and 2)
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8
时间窗: Baseline, Week 8 (Part 1 and 2)
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0=none to 100= extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13
时间窗: Baseline, Week 13 (Part 1 and 2)
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
次要结局
- Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1(Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion)
- Maximum Observed Plasma Concentration (Cmax) - Part 1(Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1(Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion)
- Volume of Distribution At Steady State (Vss) - Part 1(Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion)
- Volume of Distribution (Vz) - Part 1(Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion)
- Percentage of Participants With Positive Anti-tanezumab Antibody Test Results(Baseline up to Day 120)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1(Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion)
- Systemic Clearance (CL) - Part 1(Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion)
- Mean Residence Time (MRT) - Part 1(Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion)
- Plasma Decay Half-Life (t1/2) - Part 1(Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion)