Tanezumab In Osteoarthritis Of The Hip Or Knee

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO AND OXYCODONE CONTROLLED MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: placebo; Biological: tanezumab 10 mg; Biological: tanezumab 5 mg; Drug: oxycodone

Detailed Description

This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

• Study Type: Interventional
• Enrollment (Actual): 614
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-8036
    • LKH/Universitatsklinikum Graz
  • Senftenberg, Austria, A-3541
    • Nuhr Zentrum
  • Wien, Austria, A-1090
    • ClinPharm International GmbH
  • Wien, Austria, A-1100
    • Rheuma Zentrum Favoriten
  • Wien, Austria, A-1090
    • Synexus ClinPharm GmbH
• Denmark
  • Aalborg, Denmark, 9000
    • CCBR A/S
  • Ballerup, Denmark, 2750
    • CCBR A/S
  • Frederiksberg, Denmark, 2000
    • Frederiksberg Hospital Parker Institute
  • Vejle, Denmark, 7100
    • CCBR A/S
• Germany
  • Berlin, Germany, 13125
    • Klinische Forschung Berlin-Buch GmbH
  • Berlin, Germany, 10117
    • Charite Universitatsmedizin Berlin
  • Berlin, Germany, 13125
    • Viereck-Apotheke
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum Apotheke
  • Bochum, Germany, 44787
    • Herz Apotheke
  • Bochum, Germany, 44787
    • Synexus ClinPharm GmbH
  • Bochum, Germany, 44787
    • ClinPharm International GmbH
  • Frankfurt am Main, Germany, 60596
    • Synexus ClinPharm GmbH / Frankfurt/M
  • Goppingen, Germany, 73033
    • Schiller-Apotheke
  • Goppingen, Germany, 73033
    • Schmerz und Palliativ-Zentrum Goppingen
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH
  • Hamburg, Germany, 20253
    • Falken Apotheke Hoheluft
  • Hannover, Germany, 30159
    • Klinische Forschung Hannover-Mitte GmbH
  • Hannover, Germany, 30159
    • Löwen Apotheke
  • Leipzig, Germany, 04315
    • Arkana Apotheke OHG
  • Leipzig, Germany, 04103
    • Synexus ClinPharm GmbH
  • Magdeburg, Germany, 39112
    • Apotheke im MSZ
  • Magdeburg, Germany, 39104
    • Synexus ClinPharm GmbH Pruefzentrum Magdeburg
  • Offenbach am Main, Germany, 63065
    • Schwanen Apotheke am Markt
  • Schwerin, Germany, 19055
    • Klinische Forschung Schwerin GmbH
  • Schwerin, Germany, 19057
    • Sonnenapotheke
• Poland
  • Bialystok, Poland, 15-337
    • NZOZ Centrum Medyczne
  • Krakow, Poland, 30-119
    • Szpital Specjalistyczny im. J. Dietla
  • Lublin, Poland, 20 607
    • NZOZ REUMED Sp.zo.o.
  • Poznan, Poland, 60-218
    • Medyczne Centrum Hetmańska
  • Torun, Poland, 87-100
    • NZOZ "Nasz Lekarz"
  • Warszawa, Poland, 02-256
    • Centrum Medyczne OSTEOMED NZOZ
• Spain
  • A Coruna, Spain, 15006
    • Complejo Hospitalario Universitario de A Coruña
  • Malaga, Spain, 29009
    • Hospital Regional Universitario Carlos Haya (Hospital Civil)
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya (Hospital Civil)
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15705
      • Hospital Nuestra Señora de La Esperanza
• Sweden
  • Goteborg, Sweden, 400 14
    • Me3plus AB
  • Goteborg, Sweden, 412 63
    • Me3plus AB
  • Goteborg, Sweden, 413 45
    • Avdelningen for klinisk provning, Sahlgrenska Universitetssjukhuset
  • Malmö, Sweden, 211 52
    • Center for Clinical Studies
  • Stockholm, Sweden, 115 22
    • Bragee Medect AB
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Achieve Clinical Research
    • Mobile, Alabama, United States, 36608
      • Horizon Research Group, Inc.
    • Mobile, Alabama, United States, 36608
      • Alabama Orthopaedic Clinics, PC
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center, Inc.
  • California
    • Beverly Hills, California, United States, 90211
      • Osteoporosis Medical Center
    • Buena Park, California, United States, 90620
      • Med Frontier Clinical Research
    • Burbank, California, United States, 91505
      • Providence Clinical Research
    • Fresno, California, United States, 93720
      • Valley Research
    • Santa Ana, California, United States, 92705
      • Apex Research Institute
    • Van Nuys, California, United States, 91405
      • Medvin Clinical Research
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
    • Stamford, Connecticut, United States, 06902
      • Advanced Radiology
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida
    • Cutler Bay, Florida, United States, 33189
      • Homestead Clinical Research Group, P.A.
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research
    • Fruitland Park, Florida, United States, 34731
      • Florida Clinical Research Center, LLC
    • Longwood, Florida, United States, 32779
      • Adult Medicine Specialists
    • Longwood, Florida, United States, 32779
      • Genesis Research International
    • Miami, Florida, United States, 33155
      • Community Research Foundation, Inc.
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Pinellas Park, Florida, United States, 33781
      • Advent Clinical Research Centers, Inc.
    • Saint Petersburg, Florida, United States, 33703
      • Dale G. Bramlet, MD
    • Sarasota, Florida, United States, 34232
      • Sarasota Center for Clinical Research
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Laureate Clinical Research Group
    • Marietta, Georgia, United States, 30060
      • Drug Studies America Inc.
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
    • Woodstock, Georgia, United States, 30189
      • North Goergia Internal Medicine
  • Idaho
    • Boise, Idaho, United States, 83702
      • Americana Orthopedics
    • Boise, Idaho, United States, 83702
      • Sonora Clinical Research, LLC.
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Northwest Indiana Center for Clinical Research
  • Kentucky
    • Madisonville, Kentucky, United States, 42431
      • Commonwealth BioMedical Research
  • Maryland
    • Hollywood, Maryland, United States, 20636
      • Mid-Atlantic Medical Research
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Miray Medical Center
    • Watertown, Massachusetts, United States, 02472-3930
      • MedVadis Research Corporation
    • Worcester, Massachusetts, United States, 01610
      • Clinical Pharmacology Study Group
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Incorporated
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • The Center for Clinical Trials
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Health Research
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
    • Omaha, Nebraska, United States, 68114
      • Midwest Minor Medical
    • Omaha, Nebraska, United States, 68127
      • Midwest Minor Medical
    • Omaha, Nebraska, United States, 68144
      • Midwest Minor Medical
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Diagnostic Center of Medicine
    • Las Vegas, Nevada, United States, 89144
      • Office of Matthew Barton, MD
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
  • New York
    • Roslyn, New York, United States, 11576
      • Office of Andrew J. Porges, MD PC
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • MediSpect, LLC
    • Salisbury, North Carolina, United States, 28144
      • Crescent Medical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45224
      • Hilltop Medical Research Center
    • Columbus, Ohio, United States, 43213
      • Columbus Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Health Research of Oklahoma
  • Pennsylvania
    • Downingtown, Pennsylvania, United States, 19335-2620
      • Brandywine Clinical Research
  • South Carolina
    • Greenville, South Carolina, United States, 29601-3973
      • Piedmont Arthritis Clinic, PA
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Tricities Medical Research
    • Johnson City, Tennessee, United States, 37604-1417
      • Appalachian Medical Research Inc.
  • Texas
    • Carrollton, Texas, United States, 75007
      • ClinRx Research, LLC
    • Georgetown, Texas, United States, 78628
      • Tekton Research, Inc
    • Houston, Texas, United States, 77030
      • One Step Diagnostic (X-Ray Facility)
    • Houston, Texas, United States, 77098
      • Pioneer Research Solutions
    • Leander, Texas, United States, 78641
      • Leander Healthcare Center
    • Richardson, Texas, United States, 75080
      • ClinRx Research
    • San Antonio, Texas, United States, 78218
      • Oakwell Clinical research, LLC
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

• pregnancy or intent to become pregnant
• BMI greater than 39
• other severe pain, significant cardiac, neurological or psychiatric disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Biological: tanezumab 10 mg; tanezumab 10 mg one dose at weeks 0 and 8
EXPERIMENTAL: 2	Biological: tanezumab 5 mg; tanezumab 5 mg one dose at weeks 0 and 8
PLACEBO_COMPARATOR: 4	Other: placebo; placebo
ACTIVE_COMPARATOR: 3	Drug: oxycodone; oxycodone CR, 10-40 mg q12h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis (OA) in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.	Baseline, Week 8
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.	Baseline, Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.	Baseline, Weeks 2, 4, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.	Baseline, Weeks 2, 4, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population	The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.	Baseline, Week 2, 4, 8, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population	The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population	PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic and no limitation of normal activities); 2) good (mild symptoms and no limitation of normal activities); 3) fair (moderate symptoms and limitation of some normal activities); 4) poor (severe symptoms and inability to carry out most normal activities); and 5) very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population	PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic and no limitation of normal activities); 2) good (mild symptoms and no limitation of normal activities); 3) fair (moderate symptoms and limitation of some normal activities); 4) poor (severe symptoms and inability to carry out most normal activities); and 5) very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.	Baseline, Weeks 2, 4, 8, 12, and 16
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population	OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).	Weeks 2, 4, 8, 12, and 16
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population	OMERACT-OARSI response: >=50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).	Weeks 2, 4, 8, 12, and 16
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.	Weeks 2, 4, 8, 12, and 16
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.	Weeks 2, 4, 8, 12, and 16
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 8 are reported.	Week 8
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.	Week 8
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population	PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic and no limitation of normal activities); 2) good (mild symptoms and no limitation of normal activities); 3) fair (moderate symptoms and limitation of some normal activities); 4) poor (severe symptoms and inability to carry out most normal activities); and 5) very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.	Weeks 2, 4, 8, 12, and 16
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population	PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic and no limitation of normal activities); 2) good (mild symptoms and no limitation of normal activities); 3) fair (moderate symptoms and limitation of some normal activities); 4) poor (severe symptoms and inability to carry out most normal activities); and 5) very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.	Weeks 2, 4, 8, 12, and 16
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population	Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.	Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population	Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.	Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population	The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population	The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population	Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population	Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population	Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population	Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population	SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).	Baseline, Week 12
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population	SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).	Baseline, Week 12
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population	SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.	Baseline, Week 12
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population	SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.	Baseline, Week 12
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Week 12
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Week 12
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.	Baseline, Week 12
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.	Baseline, Week 12
Number of Participants Who Discontinued From Study Due to Lack of Efficacy		Baseline up to Week 24
Time to Discontinuation From Study Due to Lack of Efficacy		Baseline up to Week 24
Number of Participants With Rescue Medication (RM) Usage	In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication.	Weeks 2, 4, 8, 12, and 16
Number of Days With Rescue Medication (RM) Usage	In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are shown in number of days of rescue medication usage per week.	Weeks 2, 4, 8, 12, and 16
Amount of Rescue Medication Used	In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are presented as total dose of acetaminophen (in mg) per week.	Weeks 2, 4, 8, 12, and 16
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total NIS score is the sum of the left and right limb scores. Total possible NIS score range 0 to 244, higher score=greater impairment.	Baseline, Weeks 2, 4, 8, 12, 16, and 18
Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)	Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure. A participant may be represented in more than 1 category.	Baseline, Week 8 and 18
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the 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 are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.	Baseline up to 112 days after last intravenous dose
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity	Pre-specified opioid-related adverse events: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty urinating, confusion and vomiting. Number of participants who experienced any of the pre-specified opioid-related adverse event are reported. Pre-specified opioid-related adverse events were assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).	Baseline up to 112 days after last intravenous dose
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity	Adverse event of abnormal peripheral sensation: allodynia, burning sensation, decreased vibratory sense, dysaesthesia, hyperaesthesia, hyperpathia, hypoaesthesia, neuralgia, neuritis, neuropathy peripheral, pallanesthesia, paraesthesia, paraesthesia oral, peripheral sensory neuropathy, polyneuropathy, sensory disturbance, sensory loss and thermohypoaesthesia. Adverse event of abnormal peripheral sensation was assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).	Baseline up to 112 days after last intravenous dose
Tanezumab Plasma Concentration	Plasma concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure.	Predose, 1 hour post-dose on Day 1, Week 8; Week 18
Total Nerve Growth Factor (NGF) Serum Concentration	Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive, and specific immune-affinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.	Predose, 1 hour post-dose on Day 1, Week 8; Predose: Week 18

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Intravenous (IV) Doses of Study Medication	Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.	Day 1 up to Week 16

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019. Erratum In: J Pain Res. 2020 Sep 14;13:2267-2268.
• Spierings ELH, Fidelholtz J, Wolfram G, Smith MD, Brown MT, West CR. A phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain. 2013 Sep;154(9):1603-1612. doi: 10.1016/j.pain.2013.04.035. Epub 2013 Apr 22.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2009
• Primary Completion (ACTUAL): December 13, 2010
• Study Completion (ACTUAL): February 4, 2011

Study Registration Dates

• First Submitted: September 25, 2009
• First Submitted That Met QC Criteria: September 25, 2009
• First Posted (ESTIMATE): September 28, 2009

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: pain; monoclonal antibody; arthritis; nerve growth factor; OA; RN624; PF-04383119
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tanezumab; Oxycodone
• Other Study ID Numbers: A4091030; 2009-013329-41 (EUDRACT_NUMBER); OA OXY STUDY (OTHER: Alias Study Number)

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.