Osteoarthritis, Knee
Conditions
Keywords
monoclonal antibody
Brief summary
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).
Interventions
DRUGPF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | 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 Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9 | 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 10 | 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 Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11 | 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 During Walking in the Past 24 Hours at Week 12 | 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 During Walking in the Past 24 Hours at Week 13 | 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 Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | 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 2 | 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 WOMAC 3.1 Subscales Scores at Week 4 | 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 8 | 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 | 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. |
| Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 |
| Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline | 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 | 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 | 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 2 | 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 3 | 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 4 | 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. |
| Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13 | 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. |
| Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17 | 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 1 | 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 2 | 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 3 | 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 | 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 | 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 6 | 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 7 | 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 8 | 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 Current Index Knee Pain at Week 9 | 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. |
| Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10 | 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 Current Index Knee Pain at Week 11 | 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 in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12 | 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. |
| Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13 | 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 Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | 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. |
| Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2 | 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 3 | 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 4 | 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 | 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 6 | 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 7 | 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 8 | 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 9 | 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 10 | 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 in the Past 24 Hours at Week 11 | 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 in the Past 24 Hours at Week 12 | 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 in the Past 24 Hours at Week 13 | 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 1 | 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 | 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 3 | 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 Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4 | 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 5 | 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 6 | 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 7 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | AUC (0-infinity) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity). |
| 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 | AUClast is defined as the area under the plasma concentration time-curve from zero to the last measured concentration. |
| 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 | Vz is defined as the the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. |
| 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 | Vss is defined as the the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. It is the apparent volume of distribution at steady-state. |
| 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 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| 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 | MRT was calculated as area under the moment curve/area under the concentration effect curve. |
| 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 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Percentage of Participants With Positive Anti-tanezumab Antibody Test Results | Baseline up to Day 120 | Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). |
| 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 | — |
Countries
Japan
Participant flow
Pre-assignment details
A total of 83 participants were enrolled in this study, out of which 42 were enrolled in Part 1 and remaining 41 in Part 2.
Participants by arm
| Arm | Count |
|---|---|
| Tanezumab 10 mcg/kg Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | 15 |
| Tanezumab 25 mcg/kg Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | 15 |
| Tanezumab 50 mcg/kg Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | 15 |
| Tanezumab 100 mcg/kg Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | 16 |
| Tanezumab 200 mcg/kg Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1. | 6 |
| Placebo Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2. | 16 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Tanezumab 10 mcg/kg | Tanezumab 25 mcg/kg | Tanezumab 50 mcg/kg | Tanezumab 100 mcg/kg | Tanezumab 200 mcg/kg | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 36-45 Years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized 46-55 Years | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 1 Participants | 4 Participants | 19 Participants |
| Age, Customized 56-65 Years | 12 Participants | 11 Participants | 10 Participants | 9 Participants | 5 Participants | 11 Participants | 58 Participants |
| Age, Customized 66-75 Years | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 11 Participants | 12 Participants | 5 Participants | 11 Participants | 57 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 4 Participants | 4 Participants | 1 Participants | 5 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 15 | 4 / 15 | 9 / 15 | 8 / 16 | 6 / 6 | 13 / 16 |
| serious Total, serious adverse events | 1 / 15 | 1 / 15 | 0 / 15 | 0 / 16 | 0 / 6 | 0 / 16 |
Outcome results
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1
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.
Time frame: Baseline, Week 1 (Part 1 and 2)
Population: Full Analysis Set (FAS) included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Baseline | 66.5 units on a scale | Standard Deviation 22.61 |
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Change at Week 1 | -13.9 units on a scale | Standard Deviation 17.75 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Baseline | 64.5 units on a scale | Standard Deviation 12.49 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Change at Week 1 | -29.7 units on a scale | Standard Deviation 22.1 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Baseline | 67.9 units on a scale | Standard Deviation 8.41 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Change at Week 1 | -15.0 units on a scale | Standard Deviation 19.96 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Baseline | 65.0 units on a scale | Standard Deviation 13.77 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Change at Week 1 | -25.2 units on a scale | Standard Deviation 20.35 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Baseline | 69.7 units on a scale | Standard Deviation 9.27 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Change at Week 1 | -46.6 units on a scale | Standard Deviation 21.62 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Baseline | 62.3 units on a scale | Standard Deviation 18.86 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | Change at Week 1 | -10.1 units on a scale | Standard Deviation 9.31 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-17.8, 13.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-34.3, -2.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-18.5, 13.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-29.4, 1.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-55.2, -13.7]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10
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.
Time frame: Baseline, Week 10 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10 | -15.5 units on a scale | Standard Deviation 20.94 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10 | -39.9 units on a scale | Standard Deviation 28.09 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10 | -25.6 units on a scale | Standard Deviation 23.44 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10 | -31.2 units on a scale | Standard Deviation 18.94 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10 | -41.2 units on a scale | Standard Deviation 14.35 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10 | -24.6 units on a scale | Standard Deviation 23.5 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-5, 26.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30, 1.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-14.6, 17]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21, 10.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35.3, 6.2]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11
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.
Time frame: Baseline, Week 11 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11 | -17.1 units on a scale | Standard Deviation 19.92 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11 | -38.0 units on a scale | Standard Deviation 25.04 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11 | -25.4 units on a scale | Standard Deviation 23.41 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11 | -30.6 units on a scale | Standard Deviation 17.75 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11 | -41.4 units on a scale | Standard Deviation 20.24 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11 | -25.7 units on a scale | Standard Deviation 23.27 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-13.3, 18.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-5.5, 26.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-27, 4.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-19.2, 11.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-34.4, 7]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12
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.
Time frame: Baseline, Week 12 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12 | -16.2 units on a scale | Standard Deviation 21.34 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12 | -34.7 units on a scale | Standard Deviation 24.93 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12 | -25.8 units on a scale | Standard Deviation 23.06 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12 | -30.3 units on a scale | Standard Deviation 18.56 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12 | -40.3 units on a scale | Standard Deviation 22.88 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12 | -25.4 units on a scale | Standard Deviation 25.76 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-4.8, 26.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.9, 7.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-14, 17.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-19.2, 12]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-33.5, 8]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13
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.
Time frame: Baseline, Week 13 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signify those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13 | -15.8 units on a scale | Standard Deviation 21.64 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13 | -32.0 units on a scale | Standard Deviation 25.89 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13 | -23.0 units on a scale | Standard Deviation 22.15 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13 | -32.0 units on a scale | Standard Deviation 19.67 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13 | -31.6 units on a scale | Standard Deviation 28.83 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13 | -25.4 units on a scale | Standard Deviation 26.56 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-4.4, 27.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.2, 10.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-11.2, 20.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-20.3, 10.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.9, 16.6]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 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.
Time frame: Baseline, Week 2 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2 | -18.6 units on a scale | Standard Deviation 19.82 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2 | -29.3 units on a scale | Standard Deviation 25.09 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2 | -11.3 units on a scale | Standard Deviation 19.89 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2 | -25.5 units on a scale | Standard Deviation 20.48 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2 | -25.1 units on a scale | Standard Deviation 26.23 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2 | -13.2 units on a scale | Standard Deviation 16.2 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-19.4, 12.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.8, 0.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-11.7, 19.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-26.6, 4.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.5, 10.9]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3
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.
Time frame: Baseline, Week 3 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3 | -21.7 units on a scale | Standard Deviation 21.33 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3 | -35.9 units on a scale | Standard Deviation 24.58 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3 | -15.3 units on a scale | Standard Deviation 22.49 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3 | -27.0 units on a scale | Standard Deviation 18.19 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3 | -23.0 units on a scale | Standard Deviation 27.44 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3 | -16.3 units on a scale | Standard Deviation 20.41 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-19.4, 12.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-34.3, -2.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-12.6, 19]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25, 6.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.4, 16.1]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4
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.
Time frame: Baseline, Week 4 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4 | -22.3 units on a scale | Standard Deviation 21.3 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4 | -37.1 units on a scale | Standard Deviation 24.96 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4 | -21.8 units on a scale | Standard Deviation 21.41 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4 | -30.6 units on a scale | Standard Deviation 18.15 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4 | -46.0 units on a scale | Standard Deviation 17.47 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4 | -18.2 units on a scale | Standard Deviation 21.73 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-18.1, 13.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-33.6, -2.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-17.2, 14.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-26.7, 4.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-46.5, -5]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5
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.
Time frame: Baseline, Week 5 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5 | -22.3 units on a scale | Standard Deviation 22.25 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5 | -38.0 units on a scale | Standard Deviation 23.44 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5 | -27.2 units on a scale | Standard Deviation 24.9 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5 | -33.8 units on a scale | Standard Deviation 19.02 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5 | -50.7 units on a scale | Standard Deviation 15.36 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5 | -19.8 units on a scale | Standard Deviation 23.07 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-16.6, 15]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32.8, -1.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21, 10.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-28.3, 2.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-49.6, -8.2]
Primary
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6
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.
Time frame: Baseline, Week 6 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6 | -22.2 units on a scale | Standard Deviation 23.49 |
| Tanezumab 25 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6 | -39.8 units on a scale | Standard Deviation 24.56 |
| Tanezumab 50 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6 | -27.7 units on a scale | Standard Deviation 24.73 |
| Tanezumab 100 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6 | -33.2 units on a scale | Standard Deviation 19.14 |
| Tanezumab 200 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6 | -51.4 units on a scale | Standard Deviation 17.13 |
| Placebo | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6 | -19.5 units on a scale | Standard Deviation 24.01 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-16.8, 14.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35, -3.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.8, 9.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-28, 3.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-50.6, -9.1]
Primary
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7
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.
Time frame: Baseline, Week 7 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7 | -18.7 units on a scale | Standard Deviation 23.34 |
| Tanezumab 25 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7 | -41.2 units on a scale | Standard Deviation 24.3 |
| Tanezumab 50 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7 | -28.5 units on a scale | Standard Deviation 24.77 |
| Tanezumab 100 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7 | -34.3 units on a scale | Standard Deviation 18.43 |
| Tanezumab 200 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7 | -47.9 units on a scale | Standard Deviation 14.28 |
| Placebo | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7 | -20.8 units on a scale | Standard Deviation 23.62 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-11.9, 19.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35.1, -3.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.3, 10.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-27.8, 3.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-45.8, -4.3]
Primary
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8
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.
Time frame: Baseline, Week 8 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8 | -17.8 units on a scale | Standard Deviation 23.35 |
| Tanezumab 25 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8 | -39.8 units on a scale | Standard Deviation 24.94 |
| Tanezumab 50 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8 | -27.6 units on a scale | Standard Deviation 24.86 |
| Tanezumab 100 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8 | -34.3 units on a scale | Standard Deviation 17.98 |
| Tanezumab 200 mcg/kg | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8 | -48.2 units on a scale | Standard Deviation 16.18 |
| Placebo | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8 | -22.7 units on a scale | Standard Deviation 23.67 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-9.1, 22.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-31.7, -0.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-18.5, 13.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.9, 5.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-44.2, -2.7]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9
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.
Time frame: Baseline, Week 9 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9 | -16.4 units on a scale | Standard Deviation 23.8 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9 | -41.2 units on a scale | Standard Deviation 26.62 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9 | -26.5 units on a scale | Standard Deviation 23.77 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9 | -33.4 units on a scale | Standard Deviation 19.6 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9 | -47.6 units on a scale | Standard Deviation 11.81 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9 | -25.8 units on a scale | Standard Deviation 24.77 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-4.6, 27]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30, 1.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-14.3, 17.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.9, 9.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-40.5, 1]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1
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.
Time frame: Baseline, Week 1 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Baseline | 74.9 units on a scale | Standard Deviation 10.11 |
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Change at Week 1 | -18.1 units on a scale | Standard Deviation 20.95 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Baseline | 69.4 units on a scale | Standard Deviation 10.46 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Change at Week 1 | -31.0 units on a scale | Standard Deviation 22.33 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Baseline | 72.3 units on a scale | Standard Deviation 6.58 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Change at Week 1 | -17.7 units on a scale | Standard Deviation 20.48 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Baseline | 69.3 units on a scale | Standard Deviation 10.45 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Change at Week 1 | -26.7 units on a scale | Standard Deviation 21.77 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Baseline | 75.5 units on a scale | Standard Deviation 7.55 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Change at Week 1 | -52.9 units on a scale | Standard Deviation 19.71 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Baseline | 69.9 units on a scale | Standard Deviation 14.58 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | Change at Week 1 | -11.0 units on a scale | Standard Deviation 11.11 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.6, 11.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-36.1, -2.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.8, 11.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-31.6, 1.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-62.6, -19]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10
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.
Time frame: Baseline, Week 10 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10 | -15.5 units on a scale | Standard Deviation 20.29 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10 | -40.8 units on a scale | Standard Deviation 29.14 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10 | -23.2 units on a scale | Standard Deviation 21.04 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10 | -32.1 units on a scale | Standard Deviation 20.85 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10 | -44.9 units on a scale | Standard Deviation 18.13 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10 | -24.8 units on a scale | Standard Deviation 27.21 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-5.1, 28.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32.1, 1.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-13.5, 19.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.1, 9.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-40.7, 2.9]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11
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.
Time frame: Baseline, Week 11 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11 | -15.1 units on a scale | Standard Deviation 16.52 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11 | -36.8 units on a scale | Standard Deviation 25.95 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11 | -23.1 units on a scale | Standard Deviation 20.8 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11 | -33.1 units on a scale | Standard Deviation 19.01 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11 | -44.8 units on a scale | Standard Deviation 21.86 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11 | -25.1 units on a scale | Standard Deviation 26.19 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-4.4, 29]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-27.8, 5.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-13.2, 20.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.9, 9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-40.4, 3.2]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12
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.
Time frame: Baseline, Week 12 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12 | -15.0 units on a scale | Standard Deviation 16.67 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12 | -34.1 units on a scale | Standard Deviation 24.63 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12 | -23.5 units on a scale | Standard Deviation 20.35 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12 | -31.6 units on a scale | Standard Deviation 19.93 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12 | -45.4 units on a scale | Standard Deviation 24.54 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12 | -23.9 units on a scale | Standard Deviation 27.7 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-5.5, 27.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-26.3, 7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-14.7, 18.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.6, 9.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-42.2, 1.4]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13
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.
Time frame: Baseline, Week 13 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13 | -13.1 units on a scale | Standard Deviation 21.25 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13 | -31.5 units on a scale | Standard Deviation 25.99 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13 | -20.7 units on a scale | Standard Deviation 19.36 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13 | -32.7 units on a scale | Standard Deviation 21.74 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13 | -35.3 units on a scale | Standard Deviation 34.29 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13 | -24.3 units on a scale | Standard Deviation 29.09 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-3.2, 30.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.3, 9.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-11.5, 21.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.1, 8.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-31.6, 12]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 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.
Time frame: Baseline, Week 2 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2 | -20.7 units on a scale | Standard Deviation 19.66 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2 | -30.7 units on a scale | Standard Deviation 25.31 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2 | -12.2 units on a scale | Standard Deviation 19.49 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2 | -26.7 units on a scale | Standard Deviation 19.8 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2 | -32.3 units on a scale | Standard Deviation 24.88 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2 | -14.2 units on a scale | Standard Deviation 19.12 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-20.9, 12.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32.6, 0.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-13.2, 20.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-28.4, 4.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-38.8, 4.8]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3
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.
Time frame: Baseline, Week 3 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3 | -24.6 units on a scale | Standard Deviation 19.91 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3 | -36.9 units on a scale | Standard Deviation 24.37 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3 | -17.3 units on a scale | Standard Deviation 22.32 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3 | -29.1 units on a scale | Standard Deviation 18.23 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3 | -26.3 units on a scale | Standard Deviation 26.71 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3 | -16.9 units on a scale | Standard Deviation 22.79 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-22.2, 11.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-36.1, -2.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-15.6, 17.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-28, 4.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.1, 13.5]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4
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.
Time frame: Baseline, Week 4 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4 | -24.4 units on a scale | Standard Deviation 19.88 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4 | -37.8 units on a scale | Standard Deviation 26.43 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4 | -22.7 units on a scale | Standard Deviation 20.63 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4 | -33.3 units on a scale | Standard Deviation 18.1 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4 | -48.8 units on a scale | Standard Deviation 19.41 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4 | -18.3 units on a scale | Standard Deviation 24.02 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-20.6, 12.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35.6, -2.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-19.6, 13.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.9, 1.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-51.2, -7.6]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5
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.
Time frame: Baseline, Week 5 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5 | -21.3 units on a scale | Standard Deviation 23.25 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5 | -38.8 units on a scale | Standard Deviation 25.14 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5 | -28.4 units on a scale | Standard Deviation 24.06 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5 | -35.6 units on a scale | Standard Deviation 18.79 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5 | -51.9 units on a scale | Standard Deviation 16.04 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5 | -19.5 units on a scale | Standard Deviation 25.46 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-16.3, 17.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35.4, -2.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.1, 9.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-31.9, 0.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-53.1, -9.5]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6
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.
Time frame: Baseline, Week 6 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6 | -22.2 units on a scale | Standard Deviation 24.42 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6 | -40.3 units on a scale | Standard Deviation 25.3 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6 | -28.9 units on a scale | Standard Deviation 24.71 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6 | -33.7 units on a scale | Standard Deviation 17.08 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6 | -54.7 units on a scale | Standard Deviation 15.52 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6 | -19.8 units on a scale | Standard Deviation 26.62 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-16.9, 16.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-36.7, -3.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.2, 9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-29.8, 3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-55.6, -12]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7
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.
Time frame: Baseline, Week 7 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7 | -18.6 units on a scale | Standard Deviation 22.81 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7 | -40.5 units on a scale | Standard Deviation 24.92 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7 | -28.2 units on a scale | Standard Deviation 24.38 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7 | -35.4 units on a scale | Standard Deviation 18.34 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7 | -49.4 units on a scale | Standard Deviation 15.06 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7 | -20.1 units on a scale | Standard Deviation 27.28 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-12.9, 20.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-36.5, -3.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.3, 10]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-31.2, 1.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-50, -6.4]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8
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.
Time frame: Baseline, Week 8 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8 | -17.5 units on a scale | Standard Deviation 23.15 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8 | -40.9 units on a scale | Standard Deviation 25 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8 | -27.3 units on a scale | Standard Deviation 23.85 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8 | -36.6 units on a scale | Standard Deviation 19.21 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8 | -52.1 units on a scale | Standard Deviation 18.37 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8 | -22.5 units on a scale | Standard Deviation 26.93 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-9.4, 24]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-34.4, -1.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-20, 13.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-29.9, 2.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-50.3, -6.7]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9
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.
Time frame: Baseline, Week 9 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9 | -16.4 units on a scale | Standard Deviation 22.8 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9 | -41.8 units on a scale | Standard Deviation 27.37 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9 | -25.9 units on a scale | Standard Deviation 21.91 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9 | -35.6 units on a scale | Standard Deviation 20.43 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9 | -50.7 units on a scale | Standard Deviation 14.75 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9 | -26.5 units on a scale | Standard Deviation 27.46 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-4.3, 29.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-31.4, 1.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-14.6, 18.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25, 7.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-44.9, -1.3]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10
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.
Time frame: Baseline, Week 10 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10 | -18.7 units on a scale | Standard Deviation 20.6 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10 | -40.6 units on a scale | Standard Deviation 28.43 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10 | -26.1 units on a scale | Standard Deviation 24.58 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10 | -32.7 units on a scale | Standard Deviation 18.45 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10 | -40.6 units on a scale | Standard Deviation 13 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10 | -24.0 units on a scale | Standard Deviation 25.24 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-8.4, 24.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32.6, 0]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-17.1, 15.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.4, 7.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-38, 4.5]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11
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.
Time frame: Baseline, Week 11 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11 | -18.9 units on a scale | Standard Deviation 18.93 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11 | -38.0 units on a scale | Standard Deviation 25.76 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11 | -25.7 units on a scale | Standard Deviation 24.08 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11 | -32.8 units on a scale | Standard Deviation 17.99 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11 | -40.5 units on a scale | Standard Deviation 19.64 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11 | -24.8 units on a scale | Standard Deviation 24.72 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-7.7, 25.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-29.2, 3.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-15.8, 16.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.6, 8.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-37, 5.5]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12
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.
Time frame: Baseline, Week 12 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12 | -17.9 units on a scale | Standard Deviation 19.78 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12 | -35.1 units on a scale | Standard Deviation 24.85 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12 | -25.9 units on a scale | Standard Deviation 24.09 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12 | -32.3 units on a scale | Standard Deviation 19.04 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12 | -39.8 units on a scale | Standard Deviation 21.06 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12 | -24.1 units on a scale | Standard Deviation 26.15 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-7.4, 25.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-27.1, 5.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-16.9, 15.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.9, 8.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-37.1, 5.4]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13
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.
Time frame: Baseline, Week 13 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13 | -15.8 units on a scale | Standard Deviation 22.6 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13 | -32.7 units on a scale | Standard Deviation 25.39 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13 | -23.6 units on a scale | Standard Deviation 22.93 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13 | -33.2 units on a scale | Standard Deviation 20.1 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13 | -30.6 units on a scale | Standard Deviation 27.65 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13 | -24.4 units on a scale | Standard Deviation 27.45 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-5.1, 27.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.4, 8.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-14.2, 18.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.3, 8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-27.6, 14.9]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 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.
Time frame: Baseline, Week 2 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2 | -20.6 units on a scale | Standard Deviation 18.94 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2 | -29.9 units on a scale | Standard Deviation 26.26 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2 | -11.5 units on a scale | Standard Deviation 19.62 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2 | -26.5 units on a scale | Standard Deviation 19.31 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2 | -24.4 units on a scale | Standard Deviation 27.09 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2 | -13.0 units on a scale | Standard Deviation 17.53 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.2, 11.8]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-33, -0.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-13.5, 19.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-29.2, 3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32.8, 9.7]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3
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.
Time frame: Baseline, Week 3 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3 | -25.9 units on a scale | Standard Deviation 19.75 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3 | -36.2 units on a scale | Standard Deviation 25.06 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3 | -16.5 units on a scale | Standard Deviation 22.85 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3 | -28.0 units on a scale | Standard Deviation 18.82 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3 | -21.2 units on a scale | Standard Deviation 28.87 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3 | -16.6 units on a scale | Standard Deviation 21.73 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-22.9, 10.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35.7, -3.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-15, 17.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-27.1, 5.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-26, 16.5]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4
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.
Time frame: Baseline, Week 4 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4 | -25.5 units on a scale | Standard Deviation 20.07 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4 | -37.9 units on a scale | Standard Deviation 26.37 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4 | -23.4 units on a scale | Standard Deviation 22.07 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4 | -32.3 units on a scale | Standard Deviation 18 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4 | -45.4 units on a scale | Standard Deviation 18.1 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4 | -18.0 units on a scale | Standard Deviation 23.39 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.1, 11.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35.9, -3.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-20.4, 12.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30, 2.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-48.8, -6.2]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5
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.
Time frame: Baseline, Week 5 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5 | -24.3 units on a scale | Standard Deviation 22.64 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5 | -38.1 units on a scale | Standard Deviation 25.13 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5 | -28.7 units on a scale | Standard Deviation 24.64 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5 | -35.4 units on a scale | Standard Deviation 19.03 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5 | -50.8 units on a scale | Standard Deviation 15.62 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5 | -18.3 units on a scale | Standard Deviation 25.31 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-19.6, 13.4]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35.8, -3.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.4, 7.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32.8, -0.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-53.9, -11.4]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6
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.
Time frame: Baseline, Week 6 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6 | -24.7 units on a scale | Standard Deviation 24.85 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6 | -40.0 units on a scale | Standard Deviation 25.22 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6 | -28.9 units on a scale | Standard Deviation 25.3 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6 | -34.1 units on a scale | Standard Deviation 17.86 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6 | -50.6 units on a scale | Standard Deviation 16.59 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6 | -18.2 units on a scale | Standard Deviation 26.35 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-20.1, 12.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-37.9, -5.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.7, 6.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-31.5, 0.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-53.7, -11.2]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7
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.
Time frame: Baseline, Week 7 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7 | -22.9 units on a scale | Standard Deviation 23.08 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7 | -41.1 units on a scale | Standard Deviation 24.78 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7 | -28.7 units on a scale | Standard Deviation 25.9 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7 | -36.1 units on a scale | Standard Deviation 18.19 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7 | -46.3 units on a scale | Standard Deviation 14.37 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7 | -19.6 units on a scale | Standard Deviation 26.21 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-17, 16]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-37.6, -4.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.1, 8.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32.2, 0]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-48.1, -5.5]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8
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.
Time frame: Baseline, Week 8 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8 | -21.2 units on a scale | Standard Deviation 23.17 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8 | -40.8 units on a scale | Standard Deviation 25.93 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8 | -28.7 units on a scale | Standard Deviation 25.65 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8 | -36.4 units on a scale | Standard Deviation 18.34 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8 | -46.7 units on a scale | Standard Deviation 16.38 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8 | -22.0 units on a scale | Standard Deviation 25.87 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-12.8, 20.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-34.8, -2.2]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.7, 11]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.1, 2.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-46, -3.5]
Primary
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9
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.
Time frame: Baseline, Week 9 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9 | -19.2 units on a scale | Standard Deviation 22.76 |
| Tanezumab 25 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9 | -41.3 units on a scale | Standard Deviation 27.52 |
| Tanezumab 50 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9 | -27.1 units on a scale | Standard Deviation 24.72 |
| Tanezumab 100 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9 | -35.2 units on a scale | Standard Deviation 19.54 |
| Tanezumab 200 mcg/kg | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9 | -46.0 units on a scale | Standard Deviation 11.44 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9 | -25.4 units on a scale | Standard Deviation 25.41 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-7.5, 25.5]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32, 0.6]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-16.7, 15.9]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.5, 6.7]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-42, 0.5]
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1
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.
Time frame: Baseline, Week 1 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Pain | 61.3 units on a scale | Standard Deviation 16.33 |
| Tanezumab 10 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Physical Function | 55.8 units on a scale | Standard Deviation 19.88 |
| Tanezumab 10 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Stiffness | 50.7 units on a scale | Standard Deviation 18.78 |
| Tanezumab 10 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Pain | -19.5 units on a scale | Standard Deviation 24.89 |
| Tanezumab 10 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Physical Function | -13.9 units on a scale | Standard Deviation 29.69 |
| Tanezumab 10 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Stiffness | -17.5 units on a scale | Standard Deviation 33.85 |
| Tanezumab 25 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Physical Function | 56.0 units on a scale | Standard Deviation 13.22 |
| Tanezumab 25 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Pain | -30.6 units on a scale | Standard Deviation 23.79 |
| Tanezumab 25 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Stiffness | -27.9 units on a scale | Standard Deviation 30.09 |
| Tanezumab 25 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Pain | 61.0 units on a scale | Standard Deviation 16.29 |
| Tanezumab 25 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Stiffness | 50.7 units on a scale | Standard Deviation 20.86 |
| Tanezumab 25 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Physical Function | -26.6 units on a scale | Standard Deviation 22.15 |
| Tanezumab 50 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Stiffness | -21.9 units on a scale | Standard Deviation 29.86 |
| Tanezumab 50 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Physical Function | -19.0 units on a scale | Standard Deviation 20.68 |
| Tanezumab 50 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Pain | -16.2 units on a scale | Standard Deviation 22.63 |
| Tanezumab 50 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Stiffness | 69.5 units on a scale | Standard Deviation 11.86 |
| Tanezumab 50 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Pain | 65.2 units on a scale | Standard Deviation 11.07 |
| Tanezumab 50 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Physical Function | 67.8 units on a scale | Standard Deviation 8.94 |
| Tanezumab 100 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Pain | -24.6 units on a scale | Standard Deviation 17.94 |
| Tanezumab 100 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Physical Function | 60.5 units on a scale | Standard Deviation 17.94 |
| Tanezumab 100 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Stiffness | 56.2 units on a scale | Standard Deviation 23.86 |
| Tanezumab 100 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Stiffness | -24.2 units on a scale | Standard Deviation 23.29 |
| Tanezumab 100 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Physical Function | -27.3 units on a scale | Standard Deviation 19.45 |
| Tanezumab 100 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Pain | 58.0 units on a scale | Standard Deviation 13.04 |
| Tanezumab 200 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Pain | 59.2 units on a scale | Standard Deviation 16.81 |
| Tanezumab 200 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Physical Function | -35.2 units on a scale | Standard Deviation 29.04 |
| Tanezumab 200 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Physical Function | 57.8 units on a scale | Standard Deviation 18.26 |
| Tanezumab 200 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Stiffness | 55.3 units on a scale | Standard Deviation 22.24 |
| Tanezumab 200 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Pain | -37.1 units on a scale | Standard Deviation 20.94 |
| Tanezumab 200 mcg/kg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Stiffness | -30.7 units on a scale | Standard Deviation 28.3 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Pain | -6.4 units on a scale | Standard Deviation 11.18 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Stiffness | 54.2 units on a scale | Standard Deviation 21.89 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Physical Function | -10.6 units on a scale | Standard Deviation 14.69 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Change at Week 1: Stiffness | -4.4 units on a scale | Standard Deviation 19.93 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Physical Function | 53.4 units on a scale | Standard Deviation 14.85 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | Baseline: Pain | 54.1 units on a scale | Standard Deviation 17.7 |
Comparison: Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.7, 6.4]
Comparison: Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-36, -4.9]
Comparison: Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-19.9, 11.4]
Comparison: Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.9, -0.4]
Comparison: Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-49.4, -8.9]
Comparison: Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-16.9, 14.3]
Comparison: Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-29.5, 1.7]
Comparison: Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-15.4, 16.5]
Comparison: Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-27.3, 3.7]
Comparison: Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-43.1, -2.4]
Comparison: Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-33.2, -0.3]
Comparison: Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-43.7, -10.8]
Comparison: Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.4, 9.9]
Comparison: Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35.6, -3.2]
Comparison: Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-45.8, -2.9]
Primary
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13
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.
Time frame: Baseline, Week 13 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Physical Function | -4.3 units on a scale | Standard Deviation 24.86 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Pain | -8.8 units on a scale | Standard Deviation 22.81 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Stiffness | -7.9 units on a scale | Standard Deviation 33.04 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Physical Function | -22.2 units on a scale | Standard Deviation 24.7 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Pain | -27.1 units on a scale | Standard Deviation 24.64 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Stiffness | -20.8 units on a scale | Standard Deviation 26.16 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Physical Function | -18.6 units on a scale | Standard Deviation 19.1 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Pain | -18.2 units on a scale | Standard Deviation 21.92 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Stiffness | -17.0 units on a scale | Standard Deviation 21.03 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Physical Function | -31.7 units on a scale | Standard Deviation 18.37 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Pain | -28.2 units on a scale | Standard Deviation 17.77 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Stiffness | -27.9 units on a scale | Standard Deviation 20.73 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Physical Function | -26.8 units on a scale | Standard Deviation 29.62 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Pain | -28.9 units on a scale | Standard Deviation 28.82 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Stiffness | -21.4 units on a scale | Standard Deviation 33.51 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Pain | -17.9 units on a scale | Standard Deviation 25.91 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Stiffness | -18.6 units on a scale | Standard Deviation 28.16 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | Change at Week 13: Physical Function | -16.5 units on a scale | Standard Deviation 25.99 |
Comparison: Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-2.5, 28.6]
Comparison: Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21, 10]
Comparison: Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-10.4, 20.9]
Comparison: Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.1, 7.5]
Comparison: Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-29.7, 10.8]
Comparison: Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-1.3, 29.8]
Comparison: Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-19.2, 12]
Comparison: Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-9.1, 22.8]
Comparison: Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.8, 5.1]
Comparison: Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-28.8, 12]
Comparison: Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-9.5, 23.4]
Comparison: Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-22.4, 10.6]
Comparison: Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-4.5, 28.9]
Comparison: Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.2, 7.2]
Comparison: Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-22.4, 20.5]
Primary
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17
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.
Time frame: Baseline, Week 17 (Part 1 and 2)
Population: FAS. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. Week 17: analysis was performed only for treatment arms Tanezumab 100 mcg/kg, 200 mcg/kg and Placebo as per analysis plan. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | Change at Week 17: Physical Function | -30.1 units on a scale | Standard Deviation 20.99 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | Change at Week 17: Pain | -26.6 units on a scale | Standard Deviation 20.14 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | Change at Week 17: Stiffness | -21.7 units on a scale | Standard Deviation 17.5 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | Change at Week 17: Physical Function | -30.1 units on a scale | Standard Deviation 24.69 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | Change at Week 17: Stiffness | -20.3 units on a scale | Standard Deviation 27.72 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | Change at Week 17: Pain | -32.3 units on a scale | Standard Deviation 18.58 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | Change at Week 17: Pain | -41.7 units on a scale | Standard Deviation 22.45 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | Change at Week 17: Stiffness | -43.3 units on a scale | Standard Deviation 20.11 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | Change at Week 17: Physical Function | -36.8 units on a scale | Standard Deviation 23.41 |
Primary
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 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.
Time frame: Baseline, Week 2 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Physical Function | -12.8 units on a scale | Standard Deviation 25.96 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Pain | -16.8 units on a scale | Standard Deviation 19.88 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Stiffness | -15.4 units on a scale | Standard Deviation 29.13 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Physical Function | -23.5 units on a scale | Standard Deviation 23.65 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Pain | -28.5 units on a scale | Standard Deviation 25.69 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Stiffness | -24.3 units on a scale | Standard Deviation 25.23 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Physical Function | -7.9 units on a scale | Standard Deviation 20.46 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Pain | -3.1 units on a scale | Standard Deviation 25.93 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Stiffness | -8.8 units on a scale | Standard Deviation 25.35 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Physical Function | -22.8 units on a scale | Standard Deviation 18.16 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Pain | -20.3 units on a scale | Standard Deviation 18.51 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Stiffness | -21.3 units on a scale | Standard Deviation 19.68 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Physical Function | -18.2 units on a scale | Standard Deviation 23.96 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Pain | -14.5 units on a scale | Standard Deviation 18.74 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Stiffness | -20.1 units on a scale | Standard Deviation 35.94 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Pain | -10.0 units on a scale | Standard Deviation 15.9 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Stiffness | -14.2 units on a scale | Standard Deviation 22.34 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | Change at Week 2: Physical Function | -11.4 units on a scale | Standard Deviation 18.53 |
Comparison: Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-18.5, 12.6]
Comparison: Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.3, 0.8]
Comparison: Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-3.2, 28.1]
Comparison: Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.1, 7.4]
Comparison: Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-23.3, 17.2]
Comparison: Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-14.9, 16.3]
Comparison: Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.5, 5.7]
Comparison: Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-3.4, 28.5]
Comparison: Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.9, 9]
Comparison: Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.2, 15.5]
Comparison: Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.4, 11.5]
Comparison: Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.3, 2.7]
Comparison: Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-0.6, 32.7]
Comparison: Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-22.9, 9.5]
Comparison: Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.5, 17.4]
Primary
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4
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.
Time frame: Baseline, Week 4 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Physical Function | -19.3 units on a scale | Standard Deviation 28.1 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Pain | -23.7 units on a scale | Standard Deviation 22.84 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Stiffness | -19.6 units on a scale | Standard Deviation 32.36 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Physical Function | -30.8 units on a scale | Standard Deviation 24.23 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Pain | -35.1 units on a scale | Standard Deviation 24.91 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Stiffness | -30.2 units on a scale | Standard Deviation 28.81 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Physical Function | -29.0 units on a scale | Standard Deviation 24.93 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Pain | -27.6 units on a scale | Standard Deviation 25.39 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Stiffness | -30.3 units on a scale | Standard Deviation 29 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Physical Function | -33.3 units on a scale | Standard Deviation 19.2 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Pain | -30.4 units on a scale | Standard Deviation 16.35 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Stiffness | -29.3 units on a scale | Standard Deviation 21.58 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Physical Function | -41.0 units on a scale | Standard Deviation 21.33 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Pain | -41.9 units on a scale | Standard Deviation 15.65 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Stiffness | -39.1 units on a scale | Standard Deviation 31.46 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Pain | -12.5 units on a scale | Standard Deviation 19.83 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Stiffness | -14.3 units on a scale | Standard Deviation 26.04 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | Change at Week 4: Physical Function | -11.6 units on a scale | Standard Deviation 24.67 |
Comparison: Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-22.9, 8.2]
Comparison: Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-34.4, -3.3]
Comparison: Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.2, 6.1]
Comparison: Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.8, -0.2]
Comparison: Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-48.1, -7.6]
Comparison: Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-21.3, 9.9]
Comparison: Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32.6, -1.4]
Comparison: Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.3, 7.5]
Comparison: Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32.2, -1.3]
Comparison: Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-47.8, -7.1]
Comparison: Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-25.5, 7.4]
Comparison: Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-36.1, -3.2]
Comparison: Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-22.1, 11.3]
Comparison: Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-30.9, 1.6]
Comparison: Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-44.4, -1.5]
Primary
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8
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.
Time frame: Baseline, Week 8 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Physical Function | -16.3 units on a scale | Standard Deviation 18.65 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Pain | -20.7 units on a scale | Standard Deviation 20.64 |
| Tanezumab 10 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Stiffness | -16.8 units on a scale | Standard Deviation 24.56 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Physical Function | -29.9 units on a scale | Standard Deviation 26.89 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Pain | -35.3 units on a scale | Standard Deviation 25.28 |
| Tanezumab 25 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Stiffness | -35.1 units on a scale | Standard Deviation 25.39 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Physical Function | -29.4 units on a scale | Standard Deviation 23.71 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Stiffness | -32.2 units on a scale | Standard Deviation 29.58 |
| Tanezumab 50 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Pain | -27.4 units on a scale | Standard Deviation 26.62 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Physical Function | -33.3 units on a scale | Standard Deviation 19.49 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Pain | -32.1 units on a scale | Standard Deviation 16.07 |
| Tanezumab 100 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Stiffness | -30.0 units on a scale | Standard Deviation 19.41 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Physical Function | -39.0 units on a scale | Standard Deviation 21.1 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Pain | -40.6 units on a scale | Standard Deviation 21.08 |
| Tanezumab 200 mcg/kg | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Stiffness | -31.1 units on a scale | Standard Deviation 27.18 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Pain | -20.1 units on a scale | Standard Deviation 19.11 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Stiffness | -18.7 units on a scale | Standard Deviation 23.16 |
| Placebo | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | Change at Week 8: Physical Function | -19.3 units on a scale | Standard Deviation 19.81 |
Comparison: Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-12.2, 18.8]
Comparison: Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-27, 4.1]
Comparison: Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-17.4, 13.9]
Comparison: Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.8, 5.8]
Comparison: Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-39.2, 1.3]
Comparison: Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-10.6, 20.6]
Comparison: Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24, 7.1]
Comparison: Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-17.1, 14.8]
Comparison: Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-24.6, 6.3]
Comparison: Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-38.2, 2.5]
Comparison: Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-18.3, 14.6]
Comparison: Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-36.5, -3.6]
Comparison: Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-19.5, 13.9]
Comparison: Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-27.1, 5.4]
Comparison: Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-32, 10.9]
Primary
Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1
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.
Time frame: Baseline, Week 1 (Part 1 and 2)
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Baseline | 75.4 units on a scale | Standard Deviation 9.32 |
| Tanezumab 10 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Change at Week 1 | -17.3 units on a scale | Standard Deviation 19.59 |
| Tanezumab 25 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Baseline | 67.3 units on a scale | Standard Deviation 11.24 |
| Tanezumab 25 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Change at Week 1 | -29.8 units on a scale | Standard Deviation 22.13 |
| Tanezumab 50 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Baseline | 70.6 units on a scale | Standard Deviation 8.63 |
| Tanezumab 50 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Change at Week 1 | -15.7 units on a scale | Standard Deviation 19.33 |
| Tanezumab 100 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Baseline | 67.8 units on a scale | Standard Deviation 10.7 |
| Tanezumab 100 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Change at Week 1 | -26.4 units on a scale | Standard Deviation 20.78 |
| Tanezumab 200 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Baseline | 69.0 units on a scale | Standard Deviation 11.37 |
| Tanezumab 200 mcg/kg | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Change at Week 1 | -45.2 units on a scale | Standard Deviation 17.49 |
| Placebo | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Baseline | 68.0 units on a scale | Standard Deviation 14.27 |
| Placebo | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | Change at Week 1 | -10.2 units on a scale | Standard Deviation 10.83 |
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-20.7, 12.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-35.6, -3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-20.5, 12.1]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-31.9, 0.3]
Comparison: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.95% CI: [-56.4, -13.8]
Primary
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline
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.
Time frame: Baseline (Part 1 and Part 2)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline | 27.1 units on a scale | Standard Deviation 3.2 |
| Tanezumab 25 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline | 26.3 units on a scale | Standard Deviation 4.48 |
| Tanezumab 50 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline | 24.1 units on a scale | Standard Deviation 4.05 |
| Tanezumab 100 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline | 26.5 units on a scale | Standard Deviation 4.29 |
| Tanezumab 200 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline | 27.2 units on a scale | Standard Deviation 1.94 |
| Placebo | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline | 25.6 units on a scale | Standard Deviation 5.14 |
Primary
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1
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.
Time frame: Day 1 (Part 1 and 2)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1 | 24.7 units on a scale | Standard Deviation 2.42 |
| Tanezumab 25 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1 | 23.2 units on a scale | Standard Deviation 4.88 |
| Tanezumab 50 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1 | 24.3 units on a scale | Standard Deviation 2.07 |
| Tanezumab 100 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1 | 27.3 units on a scale | Standard Deviation 5.16 |
| Tanezumab 200 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1 | 23.7 units on a scale | Standard Deviation 2.58 |
| Placebo | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1 | 23.5 units on a scale | Standard Deviation 3.4 |
Primary
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5
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.
Time frame: Day 4/5 (Part 1 and 2)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5 | 27.7 units on a scale | Standard Deviation 3.27 |
| Tanezumab 25 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5 | 26.7 units on a scale | Standard Deviation 3.01 |
| Tanezumab 50 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5 | 27.0 units on a scale | Standard Deviation 6.96 |
| Tanezumab 100 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5 | 29.2 units on a scale | Standard Deviation 3.92 |
| Tanezumab 200 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5 | 26.0 units on a scale | Standard Deviation 3.22 |
| Placebo | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5 | 27.0 units on a scale | Standard Deviation 3.36 |
Primary
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1
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.
Time frame: Week 1 (Part 1 and Part 2)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1 | 26.7 units on a scale | Standard Deviation 3.35 |
| Tanezumab 25 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1 | 26.6 units on a scale | Standard Deviation 4.81 |
| Tanezumab 50 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1 | 25.4 units on a scale | Standard Deviation 5.32 |
| Tanezumab 100 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1 | 25.9 units on a scale | Standard Deviation 5.15 |
| Tanezumab 200 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1 | 26.8 units on a scale | Standard Deviation 1.72 |
| Placebo | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1 | 26.9 units on a scale | Standard Deviation 4.15 |
Primary
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13
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.
Time frame: Week 13 (Part 1 and Part 2)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13 | 28.5 units on a scale | Standard Deviation 4.16 |
| Tanezumab 25 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13 | 26.8 units on a scale | Standard Deviation 5.23 |
| Tanezumab 50 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13 | 27.3 units on a scale | Standard Deviation 3.92 |
| Tanezumab 100 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13 | 28.8 units on a scale | Standard Deviation 5.87 |
| Tanezumab 200 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13 | 23.8 units on a scale | Standard Deviation 1.83 |
| Placebo | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13 | 26.0 units on a scale | Standard Deviation 4.32 |
Primary
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17
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.
Time frame: Week 17 (Part 1 and Part 2)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. Week 17 analyses was performed only for treatment arms Tanezumab 100 mcg/kg, 200 mcg/kg and Placebo as per analysis plan. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17 | 29.3 units on a scale | Standard Deviation 5.27 |
| Tanezumab 25 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17 | 27.3 units on a scale | Standard Deviation 2.07 |
| Tanezumab 50 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17 | 28.9 units on a scale | Standard Deviation 3.72 |
Primary
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 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.
Time frame: Week 2 (Part 1 and Part 2)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2 | 27.0 units on a scale | Standard Deviation 4 |
| Tanezumab 25 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2 | 27.1 units on a scale | Standard Deviation 4.32 |
| Tanezumab 50 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2 | 25.7 units on a scale | Standard Deviation 4.5 |
| Tanezumab 100 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2 | 27.0 units on a scale | Standard Deviation 5.98 |
| Tanezumab 200 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2 | 25.5 units on a scale | Standard Deviation 1.97 |
| Placebo | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2 | 27.1 units on a scale | Standard Deviation 3.6 |
Primary
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3
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.
Time frame: Week 3 (Part 1 and 2)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3 | 28.5 units on a scale | Standard Deviation 5.75 |
| Tanezumab 25 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3 | 30.3 units on a scale | Standard Deviation 3.93 |
| Tanezumab 50 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3 | 28.3 units on a scale | Standard Deviation 4.27 |
| Tanezumab 100 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3 | 31.2 units on a scale | Standard Deviation 4.49 |
| Tanezumab 200 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3 | 27.7 units on a scale | Standard Deviation 2.07 |
| Placebo | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3 | 27.8 units on a scale | Standard Deviation 4.45 |
Primary
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4
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.
Time frame: Week 4 (Part 1 and Part 2)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4 | 28.5 units on a scale | Standard Deviation 3.6 |
| Tanezumab 25 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4 | 26.4 units on a scale | Standard Deviation 5.45 |
| Tanezumab 50 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4 | 27.2 units on a scale | Standard Deviation 4.02 |
| Tanezumab 100 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4 | 27.6 units on a scale | Standard Deviation 4.86 |
| Tanezumab 200 mcg/kg | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4 | 27.0 units on a scale | Standard Deviation 3.58 |
| Placebo | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4 | 26.9 units on a scale | Standard Deviation 4.75 |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Time frame: 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)
Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 9 Participants |
| Tanezumab 10 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Tanezumab 25 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 Participants |
| Tanezumab 25 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Tanezumab 50 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 9 Participants |
| Tanezumab 50 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Tanezumab 100 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 8 Participants |
| Tanezumab 100 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Tanezumab 200 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 Participants |
| Tanezumab 200 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 13 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1
AUC (0-infinity) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Time frame: 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
Population: Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1 | 72.05 microgram*hour/milliliter (mcg*hr/mL) | Standard Deviation 36.317 |
| Tanezumab 25 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1 | 157.5 microgram*hour/milliliter (mcg*hr/mL) | Standard Deviation 25.586 |
| Tanezumab 50 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1 | 312.4 microgram*hour/milliliter (mcg*hr/mL) | Standard Deviation 38.837 |
| Tanezumab 100 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1 | 851.8 microgram*hour/milliliter (mcg*hr/mL) | Standard Deviation 281.61 |
| Tanezumab 200 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1 | 1885 microgram*hour/milliliter (mcg*hr/mL) | Standard Deviation 377.43 |
Secondary
Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1
AUClast is defined as the area under the plasma concentration time-curve from zero to the last measured concentration.
Time frame: 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
Population: Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1 | 63.19 mcg*hr/mL | Standard Deviation 32.747 |
| Tanezumab 25 mcg/kg | Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1 | 183.8 mcg*hr/mL | Standard Deviation 155.82 |
| Tanezumab 50 mcg/kg | Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1 | 303.5 mcg*hr/mL | Standard Deviation 37.119 |
| Tanezumab 100 mcg/kg | Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1 | 855.5 mcg*hr/mL | Standard Deviation 247.71 |
| Tanezumab 200 mcg/kg | Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1 | 1825 mcg*hr/mL | Standard Deviation 319.3 |
Secondary
Maximum Observed Plasma Concentration (Cmax) - Part 1
Time frame: 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
Population: Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Maximum Observed Plasma Concentration (Cmax) - Part 1 | 0.309 microgram/milliliter (mcg/mL) | Standard Deviation 0.0524 |
| Tanezumab 25 mcg/kg | Maximum Observed Plasma Concentration (Cmax) - Part 1 | 0.681 microgram/milliliter (mcg/mL) | Standard Deviation 0.2288 |
| Tanezumab 50 mcg/kg | Maximum Observed Plasma Concentration (Cmax) - Part 1 | 1.053 microgram/milliliter (mcg/mL) | Standard Deviation 0.1348 |
| Tanezumab 100 mcg/kg | Maximum Observed Plasma Concentration (Cmax) - Part 1 | 2.395 microgram/milliliter (mcg/mL) | Standard Deviation 0.339 |
| Tanezumab 200 mcg/kg | Maximum Observed Plasma Concentration (Cmax) - Part 1 | 4.789 microgram/milliliter (mcg/mL) | Standard Deviation 0.6948 |
Secondary
Mean Residence Time (MRT) - Part 1
MRT was calculated as area under the moment curve/area under the concentration effect curve.
Time frame: 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
Population: Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Mean Residence Time (MRT) - Part 1 | 17.47 days | Standard Deviation 8.9511 |
| Tanezumab 25 mcg/kg | Mean Residence Time (MRT) - Part 1 | 18.08 days | Standard Deviation 4.6284 |
| Tanezumab 50 mcg/kg | Mean Residence Time (MRT) - Part 1 | 19.92 days | Standard Deviation 3.6745 |
| Tanezumab 100 mcg/kg | Mean Residence Time (MRT) - Part 1 | 23.22 days | Standard Deviation 6.3625 |
| Tanezumab 200 mcg/kg | Mean Residence Time (MRT) - Part 1 | 33.02 days | Standard Deviation 6.7913 |
Secondary
Percentage of Participants With Positive Anti-tanezumab Antibody Test Results
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline up to Day 120
Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. It was planned to report combined data for Part 1 and 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tanezumab 10 mcg/kg | Percentage of Participants With Positive Anti-tanezumab Antibody Test Results | 0 percentage of participants |
| Tanezumab 25 mcg/kg | Percentage of Participants With Positive Anti-tanezumab Antibody Test Results | 0 percentage of participants |
| Tanezumab 50 mcg/kg | Percentage of Participants With Positive Anti-tanezumab Antibody Test Results | 0 percentage of participants |
| Tanezumab 100 mcg/kg | Percentage of Participants With Positive Anti-tanezumab Antibody Test Results | 0 percentage of participants |
| Tanezumab 200 mcg/kg | Percentage of Participants With Positive Anti-tanezumab Antibody Test Results | 0 percentage of participants |
Secondary
Plasma Decay Half-Life (t1/2) - Part 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 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
Population: Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Plasma Decay Half-Life (t1/2) - Part 1 | 12.47 days | Standard Deviation 6.4305 |
| Tanezumab 25 mcg/kg | Plasma Decay Half-Life (t1/2) - Part 1 | 12.83 days | Standard Deviation 4.25 |
| Tanezumab 50 mcg/kg | Plasma Decay Half-Life (t1/2) - Part 1 | 12.96 days | Standard Deviation 2.0194 |
| Tanezumab 100 mcg/kg | Plasma Decay Half-Life (t1/2) - Part 1 | 15.55 days | Standard Deviation 4.5725 |
| Tanezumab 200 mcg/kg | Plasma Decay Half-Life (t1/2) - Part 1 | 23.48 days | Standard Deviation 5.4138 |
Secondary
Systemic Clearance (CL) - Part 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: 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
Population: Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Systemic Clearance (CL) - Part 1 | 3.330 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 2.2806 |
| Tanezumab 25 mcg/kg | Systemic Clearance (CL) - Part 1 | 3.807 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 0.5984 |
| Tanezumab 50 mcg/kg | Systemic Clearance (CL) - Part 1 | 3.838 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 0.5086 |
| Tanezumab 100 mcg/kg | Systemic Clearance (CL) - Part 1 | 2.817 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 1.3324 |
| Tanezumab 200 mcg/kg | Systemic Clearance (CL) - Part 1 | 2.547 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 0.4058 |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
Time frame: 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
Population: Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tanezumab 10 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 | 0.334 Hour |
| Tanezumab 25 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 | 0.500 Hour |
| Tanezumab 50 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 | 1.00 Hour |
| Tanezumab 100 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 | 0.750 Hour |
| Tanezumab 200 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 | 0.750 Hour |
Secondary
Volume of Distribution At Steady State (Vss) - Part 1
Vss is defined as the the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. It is the apparent volume of distribution at steady-state.
Time frame: 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
Population: Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Volume of Distribution At Steady State (Vss) - Part 1 | 49.98 mL/kg | Standard Deviation 15.192 |
| Tanezumab 25 mcg/kg | Volume of Distribution At Steady State (Vss) - Part 1 | 66.98 mL/kg | Standard Deviation 23.556 |
| Tanezumab 50 mcg/kg | Volume of Distribution At Steady State (Vss) - Part 1 | 75.56 mL/kg | Standard Deviation 16.329 |
| Tanezumab 100 mcg/kg | Volume of Distribution At Steady State (Vss) - Part 1 | 62.74 mL/kg | Standard Deviation 5.6509 |
| Tanezumab 200 mcg/kg | Volume of Distribution At Steady State (Vss) - Part 1 | 82.56 mL/kg | Standard Deviation 10.74 |
Secondary
Volume of Distribution (Vz) - Part 1
Vz is defined as the the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time frame: 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
Population: Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mcg/kg | Volume of Distribution (Vz) - Part 1 | 51.10 milliliter per kilogram (mL/kg) | Standard Deviation 16.636 |
| Tanezumab 25 mcg/kg | Volume of Distribution (Vz) - Part 1 | 67.52 milliliter per kilogram (mL/kg) | Standard Deviation 30.705 |
| Tanezumab 50 mcg/kg | Volume of Distribution (Vz) - Part 1 | 71.08 milliliter per kilogram (mL/kg) | Standard Deviation 10.874 |
| Tanezumab 100 mcg/kg | Volume of Distribution (Vz) - Part 1 | 60.21 milliliter per kilogram (mL/kg) | Standard Deviation 8.9428 |
| Tanezumab 200 mcg/kg | Volume of Distribution (Vz) - Part 1 | 84.30 milliliter per kilogram (mL/kg) | Standard Deviation 12.885 |