A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND,LONG TERM STUDY OF THE SAFETY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip
• Intervention / Treatment: Drug: Tanezumab 2.5 mg; Drug: Tanezumab 5 mg; Drug: Tanezumab 10 mg

Detailed Description

Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 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): 679
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Mobile Diagnostic Center
    • Mobile, Alabama, United States, 36608
      • Seton Medical Management, Inc.
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Phoenix Rheumatology Specialists, Ltd.
    • Scottsdale, Arizona, United States, 85258
      • Advanced Arthritis Care and Research
    • Scottsdale, Arizona, United States, 85251
      • Radiant Research, Inc
    • Tucson, Arizona, United States, 85704
      • Catalina Pointe Clinical Research, Inc
  • Arkansas
    • Fort Smith, Arkansas, United States, 72903
      • Ft. Smith Rheumatology, PC
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
    • Little Rock, Arkansas, United States, 72205
      • Radiology Consultants
    • Little Rock, Arkansas, United States, 72205
      • Larry Watkins, MD
    • Little Rock, Arkansas, United States, 72205
      • OrthoArkansas, PA
  • California
    • Covina, California, United States, 91723
      • Medvin Clinical Research
    • Los Angeles, California, United States, 90045
      • Pacific Arthritis Care Center
    • Northridge, California, United States, 91325
      • Staywell Research
    • Northridge, California, United States, 91325
      • University Imaging Centers
    • San Leandro, California, United States, 94578
      • C Michael Neuwelt, MD
    • Santa Maria, California, United States, 93454
      • Pacific Arthritis Center Medical Group
    • Whittier, California, United States, 90606
      • Medvin Clinical Research
  • Florida
    • Boca Raton, Florida, United States, 33486
      • RASF Clinical Research Center
    • Lauderdale Lake, Florida, United States, 33319
      • Sunrise Medical Research
    • Melbourne, Florida, United States, 32901
      • Osler Medical, Inc.
    • Melbourne, Florida, United States, 32901
      • Melbourne Internal Medicine Associates
    • Melbourne, Florida, United States, 32901
      • MIMA Century Research Associate
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocala, Florida, United States, 34474
      • Paddock Park Clinical Research
    • Ocala, Florida, United States, 34471
      • American Family Medical
    • Ocala, Florida, United States, 344471
      • Renstar Medical Research
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida
    • Pensacola, Florida, United States, 32504
      • Pensacola Research Consultants, Inc.
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research, Inc
    • Plantation, Florida, United States, 33324
      • Jarred Frydman, DO
    • Plantation, Florida, United States, 33324
      • Orthopaedic Center of South Flordia
    • Port Orange, Florida, United States, 32127
      • Advanced Medical Research
    • South Miami, Florida, United States, 33143
      • Center for Arthritis and Rheumatic Diseases
    • Tampa, Florida, United States, 33614
      • Tampa Medical Group, P.A.
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Arthritis Center of North Georgia
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Radiant Research, Inc
    • Peoria, Illinois, United States, 61602
      • Methodist Research Administration Office
    • Peoria, Illinois, United States, 61602
      • Methodist Medical Group Rheumatology
    • Rockford, Illinois, United States, 61103-3692
      • Rockford Health Physicians
  • Kansas
    • Overland Park, Kansas, United States, 66202
      • Radiant Research, Inc
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Graves Gilbert Clinic
    • Lexington, Kentucky, United States, 40504
      • Kentucky Medical Research Center
    • Mount Sterling, Kentucky, United States, 40353
      • Central Kentucky Research Associates
    • Mount Sterling, Kentucky, United States, 40353
      • Mt. Sterling Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Boston Clinical Trails, Inc.
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Woodrail Clinic
    • Columbia, Missouri, United States, 65212
      • University Physicians
    • Lee's Summit, Missouri, United States, 64086
      • Kansas City Internal Medicine
    • Saint Louis, Missouri, United States, 63117
      • Clayton Medical Research
    • Saint Louis, Missouri, United States, 63128
      • St. Louis Center for Clinical Research
    • Saint Louis, Missouri, United States, 63128
      • Advance Clinical Research Inc
    • Saint Louis, Missouri, United States, 63139
      • Barbara A. Caciolo
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research, Inc
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Internal Medical Associates of Grand Island, PC
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Radiant Research, Inc
  • New York
    • Orchard Park, New York, United States, 14127
      • Buffalo Rheumatology
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Arthritis and Osteoporosis Consultants of the Carolinas
    • Durham, North Carolina, United States, 27704
      • Robert A. Harrell, MD
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Imaging
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Radiant Research, Inc
    • Perrysburg, Ohio, United States, 43551
      • Clinical Research Source, Inc.
    • Toledo, Ohio, United States, 43623
      • Bone Joint & Spine Surgeons, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73103
      • McBride Clinic
    • Tulsa, Oklahoma, United States, 74135
      • Healthcare Research Consultants
  • Pennsylvania
    • Fleetwood, Pennsylvania, United States, 19522
      • Integrated Medical Group Pc/Fleetwood Clinical Research
    • Lancaster, Pennsylvania, United States, 17601
      • Research Across America @ Oyster Point Family Health Center
    • Philadelphia, Pennsylvania, United States, 19152
      • Arthritis Group
    • Wexford, Pennsylvania, United States, 15090
      • Allegheny North Arthritis Center
    • Yardley, Pennsylvania, United States, 19067
      • Jeffry A. Lindenbaum D.O., P.C.
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
    • Anderson, South Carolina, United States, 29621
      • Primary Care Associates
    • Anderson, South Carolina, United States, 29621
      • Anderson Radiology
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Health Specialists
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Sarah Cannon Research Institute, LLC
    • Germantown, Tennessee, United States, 38138
      • Wolf River Medical Group. LLC
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic, PA
  • Texas
    • Carrollton, Texas, United States, 75007
      • Office of John M. Joseph, M.D.
    • Dallas, Texas, United States, 75231
      • Arthritis Care and Diagnostic Center
    • Houston, Texas, United States, 77090
      • Houston Medical Research Associates
    • Houston, Texas, United States, 77090
      • Nothwest Diagonstic Clinic, PA
    • San Antonio, Texas, United States, 78232
      • Arthritis & Osteoporosis Center of South Texas
    • Sugar Land, Texas, United States, 77479
      • Texas Research Center, LP
    • Tyler, Texas, United States, 75701
      • Trinity Clinic, Office of Research Administration
    • Tyler, Texas, United States, 75701
      • Trinity Clinic, Rheumatology
  • Utah
    • Draper, Utah, United States, 84020
      • Physicians' Research Options, LLC
    • Draper, Utah, United States, 84070
      • Lone Peak Family Medicine
    • West Valley City, Utah, United States, 84120
      • Granger Medical Clinic
  • Virginia
    • Burke, Virginia, United States, 22015
      • Arthritis and Rheumatic Disease Associates, PC
    • Richmond, Virginia, United States, 23226
      • Alan E. Schulman, MD
    • Richmond, Virginia, United States, 23294
      • Steven Maestrello, M.D.
  • Washington
    • Kirkland, Washington, United States, 98034
      • Richard Neiman, MD Inc.
    • Olympia, Washington, United States, 98502
      • South Puget Sound Clinical Research Center
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center, Inc.
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Rheumatology and Pulmonary Clinic
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Aurora Advanced Healthcare
    • Racine, Wisconsin, United States, 53406
      • Arthritis Clinic

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 knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);

Exclusion Criteria:

• Body mass index (BMI) of >39 kg/m2;
• Pregnancy or intent to become pregnant
• Planned surgical procedure during the duration of the study
• History of clinically significant cardiovascular, central nervous system or psychiatric disease
• Previous exposure to exogenous NGF or to an anti NGF antibody;
• Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tanezumab 5 mg	Drug: Tanezumab 5 mg; Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year; Other Names: Biological
Experimental: Tanezumab 10 mg	Drug: Tanezumab 10 mg; Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year; Other Names: Biological
Experimental: Tanezumab 2.5 mg	Drug: Tanezumab 2.5 mg; Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year; Other Names: Biological

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) or 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. 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.	Baseline up to 112 days after last dose of study medication (up to 345 days)
Number of Participants With Laboratory Abnormalities	Laboratory analysis included blood chemistry, hematology, urinalysis and pregnancy test.	Baseline to Week 50
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 adverse events were presented.	Baseline up to Week 50
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2	NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.	Baseline, Week 2
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4	NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.	Baseline, Week 4
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8	NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.	Baseline, Week 8
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16	NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.	Baseline, Week 16
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24	NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.	Baseline, Week 24
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32	NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.	Baseline, Week 32
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40	NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.	Baseline, Week 40
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48	NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.	Baseline, Week 48
Number of Participants With Clinically Significant Change From Baseline in Physical Findings	Physical examination included examination of abdomen, ears, extremities, eyes, head, heart, lungs, lymph nodes, neck, nose, skin, throat, thyroid, muscoskeletal, neurological and peripheral vascular system.	Baseline to Week 50
Number of Participants With Anti-Drug Antibody (ADA) at Day 1	Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).	Day 1
Number of Participants With Anti-Drug Antibody (ADA) at Week 8	Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.	Week 8
Number of Participants With Anti-Drug Antibody (ADA) at Week 24	Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.	Week 24
Number of Participants With Anti-Drug Antibody (ADA) at Week 50	Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.	Week 50
Number of Participants With Vital Sign Abnormalities	Examination of vital signs included body temperature, systolic blood pressure, diastolic blood pressure, pulse rate and respiratory rate. Participants with abnormal vital sign findings reported as adverse events were presented.	Baseline up to Week 50
Number of Participants With Injection-Site Reactions at Day 1	Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).	Day 1
Number of Participants With Injection-Site Reactions at Week 2	Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).	Week 2
Number of Participants With Injection-Site Reactions at Week 4	Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).	Week 4
Number of Participants With Injection-Site Reactions at Week 8	Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).	Week 8
Number of Participants With Injection-Site Reactions at Week 16	Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).	Week 16
Number of Participants With Injection-Site Reactions at Week 24	Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).	Week 24
Number of Participants With Injection-Site Reactions at Week 32	Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).	Week 32
Number of Participants With Injection-Site Reactions at Week 40	Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).	Week 40

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 Week 2, 4, 8, 16, 24, 32, 40, 48 and 56	WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It was calculated as mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 to 10, where higher scores indicated higher pain.	Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56	WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint and index hip during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on NRS of 0 to 10, with higher scores indicated worse function. Total score range for WOMAC physical function subscale score was 0 to 10, where higher scores indicated worse function.	Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56	Participants answered: "Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities).	Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response	OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit 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).	Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score	Percentage of participants with at least 30%, 50%, 70% and 90% reduction from baseline in WOMAC pain subscale score are reported. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It was calculated as mean of the scores from the 5 individual questions scored on a 0 to 10 NRS, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicated higher pain.	Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score	WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It is calculated as mean of the scores from 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. Participants with specified reduction (as percent) from baseline at Week 16 are reported.	Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis	Participants answered: "Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value.	Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56	WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or index hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of 0 to 10, with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee or hip.	Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56	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 osteoarthritis of knee or hip. Each item was scored on a 0 to 10 NRS scale, where higher scores indicated higher pain/stiffness or worse function. WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranged from 0 to 10, where higher score indicated worse response.	Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56	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.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56	Participants answered: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
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 50
Number of Participants Who Discontinued Due to Lack of Efficacy		Baseline up to Week 50
Percentage of Participants Who Used Concomitant Analgesic Medication	United States Food and Drug Administration (FDA) approved analgesics were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator.	Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64
Days Per Week of Concomitant Analgesic Medication Usage	United States FDA-approved analgesics were permitted as concomitant medications to relieve the pain of OA. These medications included opioids, topical analgesics, NSAIDs, capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator.	Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Subcutaneous Doses of Study Medication	Number of participants are reported based on the maximum number of subcutaneous doses of study medication received.	Day 1 up to Week 24

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2009
• Primary Completion (Actual): December 7, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: October 12, 2009
• First Submitted That Met QC Criteria: October 13, 2009
• First Posted (Estimate): October 14, 2009

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Double-blind safety
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tanezumab
• Other Study ID Numbers: A4091043; SC OA SAFETY STUDY (Other Identifier: 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.