Tanezumab in Osteoarthritis of the Hip or Knee (2)

A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 849
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Greystone Medical Research, LLC
    • Huntsville, Alabama, United States, 35801
      • Saadat Ansari, MD
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Clinical Research Advantage, Inc. / Central Arizona Medical Associates, PC
    • Mesa, Arizona, United States, 85206
      • Novara Clinical Research
    • Mesa, Arizona, United States, 85213
      • Clinical Research Advantage, Inc.
    • Phoenix, Arizona, United States, 85020
      • Central Phoenix Medical - Clinical Research Advantage
    • Tucson, Arizona, United States, 85705
      • Paradigm Clinical, Inc
  • California
    • Chula Vista, California, United States, 91911
      • eStudySite
    • Englewood, California, United States, 80113
      • Orthopedic Physicians of Colorado, PC
    • Englewood, California, United States, 80113
      • University Parks Hematology/Oncology
    • Fountain Valley, California, United States, 92708
      • Edinger Medical Group and Research Center
    • Fresno, California, United States, 93720
      • Valley Research
    • Lakewood, California, United States, 90712
      • Lakewood Orthopedic Medical & Surgical Group
    • Lancaster, California, United States, 93534
      • High Desert Medical Group Research for Life
    • Long Beach, California, United States, 90807
      • Premiere Clinical Research, LLC
    • Los Angeles, California, United States, 90036
      • Miracle Mile Medical Center
    • Los Gatos, California, United States, 95032
      • Samaritan Center for Medical Research
    • Reseda, California, United States, 91335
      • Del Carmen Medical Center
    • Santa Ana, California, United States, 92701
      • Probe Clinical Research, Corp.
    • Thousand Oaks, California, United States, 91360
      • Lawrence P.McAdam, MD, A Medical Corporation
    • Westlake Village, California, United States, 91361
      • Westlake Medical Center
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Peak Anesthesia and Pain Management
    • Denver, Colorado, United States, 80209
      • Denver Internal Medicine Group
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research, Inc.
    • Englewood, Colorado, United States, 80110
      • Colorado Orthopedic Consultants, PC
    • Englewood, Colorado, United States, 80110
      • Colorado Hematology
    • Englewood, Colorado, United States, 80113
      • American Clinical Research, LLC
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Norwalk Medical Group
  • Delaware
    • Lewes, Delaware, United States, 19958
      • Rheumatology Consultants of Delaware
  • Florida
    • Bradenton, Florida, United States, 34202
      • HeartCare
    • Doral, Florida, United States, 33166
      • In Vivo Clinical Research, Inc
    • Fort Lauderdale, Florida, United States, 33306
      • S & W Clinical Research
    • Fort Lauderdale, Florida, United States, 33334
      • Centre for Rheumatology, Immunology and Arthritis
    • Miami, Florida, United States, 33175
      • Kendall South Medical Center, Inc
    • Opa-locka, Florida, United States, 33054
      • Sunshine Research Center
    • Orlando, Florida, United States, 32806
      • Rheumatology Associates of Central Florida, PA
    • Sarasota, Florida, United States, 34232
      • Heartcare Research
    • Tampa, Florida, United States, 33614
      • Tampa Medical Group Pa
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Masters of Clinical Research, Inc.
    • Blue Ridge, Georgia, United States, 30513
      • River Birch Research Alliance, Llc
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Millennium Pain Center
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago
  • Indiana
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • The Pain Treatment Center of the Bluegrass
    • Lexington, Kentucky, United States, 40503
      • Pasadena Pharmacy
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Gulf Coast Research, LLC
    • Baton Rouge, Louisiana, United States, 70808
      • Bone and Joint Clinic of Baton Rouge
  • Maryland
    • Hollywood, Maryland, United States, 20636
      • Mid-Atlantic Medical Research Centers
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research, LLC
    • Brockton, Massachusetts, United States, 02301
      • Miray Medical Center
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Incorporated
  • Mississippi
    • Port Gibson, Mississippi, United States, 39150
      • Planters Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Medex Healthcare Research, Inc.
    • Springfield, Missouri, United States, 65807
      • St. John's Medical Research Institute, Inc.
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Diagnositc Center of Medicine
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium
    • Las Vegas, Nevada, United States, 89103
      • Independent Clinical Researchers
    • Las Vegas, Nevada, United States, 89103
      • Wolfson Medical Center
  • New York
    • Bronx, New York, United States, 10454
      • SPRI Bronx LLC
    • New York, New York, United States, 10004
      • Medex Healthcare Research, Inc.
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Columbus Clinical Research, Inc.
    • Dayton, Ohio, United States, 45439
      • Providence Health Partners - Center For Clinical Research
    • Middletown, Ohio, United States, 45042
      • Signal Point Clinical Research Center, LLC
    • Middletown, Ohio, United States, 45042
      • Orthopedic & Sports Medicine Consultants
    • Zanesville, Ohio, United States, 43701
      • Physicians' Research, Inc
    • Zanesville, Ohio, United States, 43701
      • Primecare of Southeastern Ohio, Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research, LLC
  • South Carolina
    • Clinton, South Carolina, United States, 29325
      • The Family Healthcare Center, PA
    • Columbia, South Carolina, United States, 29204
      • Southern Orthopaedic Sports Medicine
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
    • North Charleston, South Carolina, United States, 29406
      • Low Country Rheumatology, PA
    • Rock Hill, South Carolina, United States, 29732
      • The Carolina Center for Rheumatology and Arthritis Care, PA
    • Simpsonville, South Carolina, United States, 29681
      • Palmetto Clinical Trial Services, LLC
  • Texas
    • Austin, Texas, United States, 78745
      • South Austin Orthopedics
    • Austin, Texas, United States, 78746
      • Tekton Research Inc. - Research Office
    • Grapevine, Texas, United States, 76051
      • Texas Orthopedic Specialists
    • Houston, Texas, United States, 77030
      • Foundation for Southwest Orthopedic Research
    • Houston, Texas, United States, 77030
      • Southwest Orthopedic Group
    • Houston, Texas, United States, 77030
      • The Neurology Center
    • Lubbock, Texas, United States, 79410
      • Gill Orthopedic Center
    • Lubbock, Texas, United States, 79410
      • Robert R. King, M.D., PA
    • Sugar Land, Texas, United States, 77478
      • AZ Clinical Research
    • Sugar Land, Texas, United States, 77478
      • Spring Clinical Research
    • Sugar Land, Texas, United States, 77479
      • Sugar Land Med-Ped, P.A.
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc. / Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Incorporated/Foothill Family Clinic South
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Virginia Hospital Center
    • Arlington, Virginia, United States, 22205
      • Commonwealth Orthopedics & Rehabilitation , P.C.
    • Arlington, Virginia, United States, 22205
      • IntegraTrials, LLC
    • Roanoke, Virginia, United States, 24018
      • HypotheTest, LLC
  • Washington
    • Selah, Washington, United States, 98942
      • Empirical Clinical Trials, LLC
    • Spokane, Washington, United States, 99204-2336
      • Arthritis Northwest, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Osteoarthritis of the hip or knee 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 Assignment
• 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 to match tanezumab and naproxen dosing
Active Comparator: 3	Drug: naproxen; naproxen 1000 mg daily for 16 weeks

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 at Week 16: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Week 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.	Baseline, Week 16
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and 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 and inability to carry out all normal activities). Higher scores indicated worse condition.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Discontinuation Due to Lack of Efficacy	Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.	Baseline up to Week 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, and 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.	Baseline, Weeks 2, 4, 8, and 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and 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 and inability to carry out all normal activities). Higher scores indicated worse condition.	Baseline, Weeks 2, 4, 8, and 12
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and 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 and inability to carry out all normal activities). Higher scores indicated worse condition.	Baseline, Weeks 2, 4, 8, 12, and 16
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.	Weeks 2, 4, 8, 12, and 16
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.	Weeks 2, 4, 8, 12, and 16
Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.	Weeks 2, 4, 8, 12, and 16
Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.	Weeks 2, 4, 8, 12, and 16
Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and 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 and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.	Weeks 2, 4, 8, 12, and 16
Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and 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 and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.	Weeks 2, 4, 8, 12, and 16
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.	Baseline up to Week 16
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0%; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.	Baseline up to Week 16
Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF)	Participants assessed their average daily pain score in the index hip/knee using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. A weekly mean was calculated using the daily index hip/knee pain scores within each specified study week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness.	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: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [worst stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no difficulty) to 10 (maximum difficulty), where higher scores indicated worse response.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher 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 and 16: Baseline Observation Carried Forward (BOCF)	The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum), where higher score indicated a better health related quality of life.	Baseline, Weeks 12, and 16
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF)	The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.	Baseline, Weeks 12, and 16
Percentage of Participants Who Used Rescue Medication	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized.	Weeks 2, 4, 8, 12, and 16
Duration of Rescue Medication Use	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized.	Weeks 2, 4, 8, 12, and 16
Amount of Rescue Medication Taken	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.	Weeks 2, 4, 8, 12, and 16
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.	Baseline (Day 1) up to Week 24
Number of Participants With Laboratory Test Abnormalities	Laboratory values: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3*ULN), electrolytes (sodium<0.95* LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1).	Baseline (Day 1) up to Week 24
Number of Participants With Abnormal Electrocardiogram (ECG) Findings	All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as treatment related adverse events were presented. Relatedness to treatment was assessed by investigator.	Baseline (Day 1) up to Week 24
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24	NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 122 (maximum impairment), higher scores indicated increased impairment.	Baseline, Weeks 2, 4, 8, 12, 16, and 24
Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: Tanezumab 5 mg + Placebo and Tanezumab 10 mg + Placebo. Results with titer value >= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive.	Baseline, Weeks 8, 16, and 24
Number of Participants With Abnormal Physical Examinations Findings	Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others. Criteria for abnormal physical findings were based on investigator's discretion.	Baseline (Day 1)
Number of Participants With Adverse Events Associated With Vital Sign Measurements	Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant vital signs (based on the investigator's judgment) considered as adverse events were reported.	Baseline (Day 1) up to Week 24

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.
• Ekman EF, Gimbel JS, Bello AE, Smith MD, Keller DS, Annis KM, Brown MT, West CR, Verburg KM. Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: 2 randomized controlled trials versus naproxen. J Rheumatol. 2014 Nov;41(11):2249-59. doi: 10.3899/jrheum.131294. Epub 2014 Oct 1.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2009
• Primary Completion (Actual): April 27, 2010
• Study Completion (Actual): August 16, 2010

Study Registration Dates

• First Submitted: March 13, 2009
• First Submitted That Met QC Criteria: March 16, 2009
• First Posted (Estimate): March 17, 2009

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Tanezumab; Naproxen
• Other Study ID Numbers: A4091018

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.