A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee

A PHASE 1/2A, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND, DOSE-ESCALATION, MULTICENTER STUDY OF THE SAFETY, TOLERABILITY, EFFICACY AND PHARMACOKINETICS, OF A SINGLE INTRAVENOUS DOSE OF PF-04383119 IN JAPANESE PATIENTS WITH MODERATE TO SEVERE PAIN FROM OSTEOARTHRITIS OF THE KNEE

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: PF-04383119 (tanezumab); Drug: PF-04383119 (tanezumab); Drug: PF-04383119 (tanezumab); Drug: PF-04383119 (tanezumab); Drug: PF-04383119 (tanezumab); Drug: PF-04383119 (tanezumab)

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Gunma
    • Takasaki, Gunma, Japan, 370-0829
      • National Hospital Organization Takasaki General Medical Center
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 210-0852
      • Nippon Kokan Clinic
  • Kanagawa-ken
    • Fujisawa-shi, Kanagawa-ken, Japan, 252-0802
      • Fujisawa Shounandai Hospital
    • Yokohama-shi, Kanagawa-ken, Japan, 224-0024
      • Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital
  • Oita
    • Beppu-shi, Oita, Japan, 874-0937
      • Nakamura Hospital
  • Tokyo
    • Fuchu City,, Tokyo, Japan, 183-8524
      • Tokyo Metropolitan Fuchu Hospital
    • Minato-ku, Tokyo, Japan, 106-8581
      • FuruKawabashi Hospital
    • Minato-ku, Tokyo, Japan, 108-8639
      • Research Hospital, The Institute of Medical Science, The University of Tokyo
    • Shinagawa-ku, Tokyo, Japan, 140-0001
      • Kitashinagawa Third Hospital
    • Shinagawa-ku, Tokyo, Japan, 141-0001
      • Oosaki Hospital Tokyo Heart Center
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • Kanto Medical Center NTT EC
    • Shinjuku-ku, Tokyo, Japan, 162-8655
      • International Medical Center of Japan Toyama Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: PF-04383119 (tanezumab); single dose of 10 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 100 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 200 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 25 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 50 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of Placebo IV
Experimental: 100 mcg/kg	Drug: PF-04383119 (tanezumab); single dose of 10 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 100 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 200 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 25 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 50 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of Placebo IV
Experimental: 200 mcg/kg	Drug: PF-04383119 (tanezumab); single dose of 10 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 100 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 200 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 25 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 50 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of Placebo IV
Experimental: 10 mcg/kg	Drug: PF-04383119 (tanezumab); single dose of 10 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 100 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 200 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 25 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 50 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of Placebo IV
Experimental: 25 mcg/kg	Drug: PF-04383119 (tanezumab); single dose of 10 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 100 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 200 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 25 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 50 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of Placebo IV
Experimental: 50 mcg/kg	Drug: PF-04383119 (tanezumab); single dose of 10 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 100 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 200 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 25 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of 50 mcg/kg IV; Drug: PF-04383119 (tanezumab); single dose of Placebo IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)
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.	Baseline (Part 1 and Part 2)
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.	Day 1 (Part 1 and 2)
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.	Day 4/5 (Part 1 and 2)
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.	Week 1 (Part 1 and Part 2)
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.	Week 2 (Part 1 and Part 2)
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.	Week 3 (Part 1 and 2)
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.	Week 4 (Part 1 and Part 2)
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.	Week 13 (Part 1 and Part 2)
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.	Week 17 (Part 1 and Part 2)
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.	Baseline, Week 1 (Part 1 and 2)
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.	Baseline, Week 2 (Part 1 and 2)
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.	Baseline, Week 3 (Part 1 and 2)
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.	Baseline, Week 4 (Part 1 and 2)
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.	Baseline, Week 5 (Part 1 and 2)
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.	Baseline, Week 6 (Part 1 and 2)
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.	Baseline, Week 7 (Part 1 and 2)
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.	Baseline, Week 8 (Part 1 and 2)
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.	Baseline, Week 9 (Part 1 and 2)
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.	Baseline, Week 10 (Part 1 and 2)
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.	Baseline, Week 11 (Part 1 and 2)
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.	Baseline, Week 12 (Part 1 and 2)
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.	Baseline, Week 13 (Part 1 and 2)
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.	Baseline, Week 1 (Part 1 and 2)
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.	Baseline, Week 2 (Part 1 and 2)
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.	Baseline, Week 3 (Part 1 and 2)
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.	Baseline, Week 4 (Part 1 and 2)
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.	Baseline, Week 5 (Part 1 and 2)
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.	Baseline, Week 6 (Part 1 and 2)
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.	Baseline, Week 7 (Part 1 and 2)
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.	Baseline, Week 8 (Part 1 and 2)
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.	Baseline, Week 9 (Part 1 and 2)
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.	Baseline, Week 10 (Part 1 and 2)
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.	Baseline, Week 11 (Part 1 and 2)
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.	Baseline, Week 12 (Part 1 and 2)
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.	Baseline, Week 13 (Part 1 and 2)
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.	Baseline, Week 1 (Part 1 and 2)
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.	Baseline, Week 2 (Part 1 and 2)
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.	Baseline, Week 3 (Part 1 and 2)
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.	Baseline, Week 4 (Part 1 and 2)
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.	Baseline, Week 5 (Part 1 and 2)
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.	Baseline, Week 6 (Part 1 and 2)
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.	Baseline, Week 7 (Part 1 and 2)
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.	Baseline, Week 8 (Part 1 and 2)
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.	Baseline, Week 9 (Part 1 and 2)
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.	Baseline, Week 10 (Part 1 and 2)
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.	Baseline, Week 11 (Part 1 and 2)
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.	Baseline, Week 12 (Part 1 and 2)
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.	Baseline, Week 13 (Part 1 and 2)
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.	Baseline, Week 1 (Part 1 and 2)
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.	Baseline, Week 2 (Part 1 and 2)
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.	Baseline, Week 4 (Part 1 and 2)
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.	Baseline, Week 8 (Part 1 and 2)
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.	Baseline, Week 13 (Part 1 and 2)
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.	Baseline, Week 17 (Part 1 and 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) - Part 1		Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1		Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
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).	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 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.	Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
Volume of Distribution (Vz) - Part 1	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.	Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
Volume of Distribution At Steady State (Vss) - Part 1	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.	Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
Systemic Clearance (CL) - Part 1	CL is a quantitative measure of the rate at which a drug substance is removed from the body.	Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
Mean Residence Time (MRT) - Part 1	MRT was calculated as area under the moment curve/area under the concentration effect curve.	Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
Plasma Decay Half-Life (t1/2) - Part 1	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
Percentage of Participants With Positive Anti-tanezumab Antibody Test Results	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).	Baseline up to Day 120

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Nagashima H, Suzuki M, Araki S, Yamabe T, Muto C; Tanezumab Investigators. Preliminary assessment of the safety and efficacy of tanezumab in Japanese patients with moderate to severe osteoarthritis of the knee: a randomized, double-blind, dose-escalation, placebo-controlled study. Osteoarthritis Cartilage. 2011 Dec;19(12):1405-12. doi: 10.1016/j.joca.2011.09.006. Epub 2011 Oct 5.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2008
• Primary Completion (Actual): December 25, 2009
• Study Completion (Actual): December 25, 2009

Study Registration Dates

• First Submitted: April 25, 2008
• First Submitted That Met QC Criteria: April 29, 2008
• First Posted (Estimate): April 30, 2008

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: monoclonal antibody
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tanezumab
• Other Study ID Numbers: A4091022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.