Phase 2
N=42
A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT00669409 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 9; 4; 9; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-04383119 (tanezumab) (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
9; 4; 9; 8; 6; 13 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline |
27.1; 26.3; 24.1; 26.5; 27.2; 25.6 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1 |
24.7; 23.2; 24.3; 27.3; 23.7; 23.5 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5 |
27.7; 26.7; 27.0; 29.2; 26.0; 27.0 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1 |
26.7; 26.6; 25.4; 25.9; 26.8; 26.9 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2 |
27.0; 27.1; 25.7; 27.0; 25.5; 27.1 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3 |
28.5; 30.3; 28.3; 31.2; 27.7; 27.8 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4 |
28.5; 26.4; 27.2; 27.6; 27.0; 26.9 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13 |
28.5; 26.8; 27.3; 28.8; 23.8; 26.0 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17 |
29.3; 27.3; 28.9 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 |
66.5; 64.5; 67.9; 65.0; 69.7; 62.3 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2 |
-18.6; -29.3; -11.3; -25.5; -25.1; -13.2 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3 |
-21.7; -35.9; -15.3; -27.0; -23.0; -16.3 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4 |
-22.3; -37.1; -21.8; -30.6; -46.0; -18.2 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5 |
-22.3; -38.0; -27.2; -33.8; -50.7; -19.8 | — |
| PRIMARY Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6 |
-22.2; -39.8; -27.7; -33.2; -51.4; -19.5 | — |
| PRIMARY Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7 |
-18.7; -41.2; -28.5; -34.3; -47.9; -20.8 | — |
| PRIMARY Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8 |
-17.8; -39.8; -27.6; -34.3; -48.2; -22.7 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9 |
-16.4; -41.2; -26.5; -33.4; -47.6; -25.8 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10 |
-15.5; -39.9; -25.6; -31.2; -41.2; -24.6 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11 |
-17.1; -38.0; -25.4; -30.6; -41.4; -25.7 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12 |
-16.2; -34.7; -25.8; -30.3; -40.3; -25.4 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13 |
-15.8; -32.0; -23.0; -32.0; -31.6; -25.4 | — |
| PRIMARY Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 |
75.4; 67.3; 70.6; 67.8; 69.0; 68.0 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2 |
-20.6; -29.9; -11.5; -26.5; -24.4; -13.0 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3 |
-25.9; -36.2; -16.5; -28.0; -21.2; -16.6 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4 |
-25.5; -37.9; -23.4; -32.3; -45.4; -18.0 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5 |
-24.3; -38.1; -28.7; -35.4; -50.8; -18.3 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6 |
-24.7; -40.0; -28.9; -34.1; -50.6; -18.2 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7 |
-22.9; -41.1; -28.7; -36.1; -46.3; -19.6 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8 |
-21.2; -40.8; -28.7; -36.4; -46.7; -22.0 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9 |
-19.2; -41.3; -27.1; -35.2; -46.0; -25.4 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10 |
-18.7; -40.6; -26.1; -32.7; -40.6; -24.0 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11 |
-18.9; -38.0; -25.7; -32.8; -40.5; -24.8 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12 |
-17.9; -35.1; -25.9; -32.3; -39.8; -24.1 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13 |
-15.8; -32.7; -23.6; -33.2; -30.6; -24.4 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 |
74.9; 69.4; 72.3; 69.3; 75.5; 69.9 | — |
| PRIMARY 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; -30.7; -12.2; -26.7; -32.3; -14.2 | — |
| PRIMARY 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; -36.9; -17.3; -29.1; -26.3; -16.9 | — |
| PRIMARY 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; -37.8; -22.7; -33.3; -48.8; -18.3 | — |
| PRIMARY 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; -38.8; -28.4; -35.6; -51.9; -19.5 | — |
| PRIMARY Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6 |
-22.2; -40.3; -28.9; -33.7; -54.7; -19.8 | — |
| PRIMARY 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; -40.5; -28.2; -35.4; -49.4; -20.1 | — |
| PRIMARY 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; -40.9; -27.3; -36.6; -52.1; -22.5 | — |
| PRIMARY 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; -41.8; -25.9; -35.6; -50.7; -26.5 | — |
| PRIMARY 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; -40.8; -23.2; -32.1; -44.9; -24.8 | — |
| PRIMARY 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; -36.8; -23.1; -33.1; -44.8; -25.1 | — |
| PRIMARY 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; -34.1; -23.5; -31.6; -45.4; -23.9 | — |
| PRIMARY 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; -31.5; -20.7; -32.7; -35.3; -24.3 | — |
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 |
61.3; 61.0; 65.2; 58.0; 59.2; 54.1 | — |
| PRIMARY Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 |
-16.8; -28.5; -3.1; -20.3; -14.5; -10.0 | — |
| PRIMARY Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 |
-23.7; -35.1; -27.6; -30.4; -41.9; -12.5 | — |
| PRIMARY Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 |
-20.7; -35.3; -27.4; -32.1; -40.6; -20.1 | — |
| PRIMARY Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 |
-8.8; -27.1; -18.2; -28.2; -28.9; -17.9 | — |
| PRIMARY Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 |
-26.6; -32.3; -41.7; -30.1; -30.1; -36.8 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) - Part 1 |
0.309; 0.681; 1.053; 2.395; 4.789 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 |
0.334; 0.500; 1.00; 0.750; 0.750 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1 |
72.05; 157.5; 312.4; 851.8; 1885 | — |
| SECONDARY Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1 |
63.19; 183.8; 303.5; 855.5; 1825 | — |
| SECONDARY Volume of Distribution (Vz) - Part 1 |
51.10; 67.52; 71.08; 60.21; 84.30 | — |
| SECONDARY Volume of Distribution At Steady State (Vss) - Part 1 |
49.98; 66.98; 75.56; 62.74; 82.56 | — |
| SECONDARY Systemic Clearance (CL) - Part 1 |
3.330; 3.807; 3.838; 2.817; 2.547 | — |
| SECONDARY Mean Residence Time (MRT) - Part 1 |
17.47; 18.08; 19.92; 23.22; 33.02 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) - Part 1 |
12.47; 12.83; 12.96; 15.55; 23.48 | — |
| SECONDARY Percentage of Participants With Positive Anti-tanezumab Antibody Test Results |
0; 0; 0; 0; 0 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00669409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.