Long Term Safety Study of Tanezumab in Chronic Low Back Pain

A RANDOMIZED, MULTICENTER, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC LOW BACK PAIN

The purpose of this study is to investigate the safety and efficacy of tanezumab for chronic low back pain. Patients who were randomized and treated with study medication in a previous chronic low back pain "parent" study will be eligible to enroll in this safety extension study at the Preferred Rollover Time Point visit or at the Early Termination visit of the parent study upon discontinuation due to lack of efficacy.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Biological: Tanezumab 20 mg; Biological: Tanezumab 10 mg

Detailed Description

This study was terminated on 30 November 2010 following a US FDA clinical hold for tanezumab chronic low back pain clinical studies which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.

• Study Type: Interventional
• Enrollment (Actual): 849
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
    • Anniston, Alabama, United States, 36201
      • Pinnacle Research Group, LLC
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, Anniston Medical Clinic
    • Birmingham, Alabama, United States, 35211
      • Simon Williamson Clinic, PC
    • Hueytown, Alabama, United States, 35023
      • Simon-Williamson Clinic, PC
    • Huntsville, Alabama, United States, 35801
      • Saadat Ansari, MD
    • Mobile, Alabama, United States, 36608
      • Horizon Research Group
    • Mobile, Alabama, United States, 36608
      • Alabama Orthopaedic Clinic
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Phoenix Diagnostic Imaging
    • Chandler, Arizona, United States, 85224
      • Radiant Research - Phoenix Southeast
    • Mesa, Arizona, United States, 85202
      • Simon Med
    • Peoria, Arizona, United States, 85381
      • Pivotal Research Centers
    • Peoria, Arizona, United States, 85381
      • Sun Radiology
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center, LLC
    • Scottsdale, Arizona, United States, 85251
      • Radiant Research
    • Scottsdale, Arizona, United States, 85251
      • Scottsdale Medical Imaging
    • Tempe, Arizona, United States, 85282
      • Premiere Phamaceutical Research, LLC
    • Tempe, Arizona, United States, 85283
      • Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Family Practice Clinic
  • California
    • Burbank, California, United States, 91505
      • Providence Clinical Research
    • Fresno, California, United States, 93720
      • Valley Research
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network, Inc.
    • La Jolla, California, United States, 92121
      • University of California San Diego
    • Los Gatos, California, United States, 95032
      • Samaritan Center for Medical Research Medical Group
    • Newport Beach, California, United States, 92660
      • Newport Diagnostic Center
    • Oceanside, California, United States, 92056
      • North County Clinical Research (NCCR)
    • Rancho Mirage, California, United States, 92270
      • Advances in Medicine
    • Roseville, California, United States, 95661
      • Trinity Medical Research
    • Sacramento, California, United States, 95823
      • Center for Clinical Trials of Sacramento, Inc.
    • San Diego, California, United States, 92120
      • Wetlin Research Associates, Inc
    • Upland, California, United States, 91786
      • Inland Rheumatology & Osteoporosis Medical Group, Inc.
    • Wildomar, California, United States, 92595
      • Elite Clinical Trials, Inc.
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Alpine Clinical Research Center
    • Colorado Springs, Colorado, United States, 80904
      • Clinicos, LLC
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
    • Stamford, Connecticut, United States, 06902
      • Advanced Radiology
    • Trumbull, Connecticut, United States, 06611
      • New England Research Associates, LLC
  • Florida
    • Chiefland, Florida, United States, 32626
      • Southeast Clinical Research
    • Chiefland, Florida, United States, 32626
      • Southeast Clinical Research, LLC
    • DeFuniak Springs, Florida, United States, 32435
      • Doctors Medical Center
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Destin, Florida, United States, 32541
      • SJS Clinical Research, Inc.
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Southeast Clinical Research, LLC
    • Naples, Florida, United States, 34102
      • Collier Neurologic Specialists
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Palm Beach Gardens, Florida, United States, 33410
      • Palm Beach Gardens Open Imaging Center
    • Pembroke Pines, Florida, United States, 33024
      • University Clinical Research
    • Pinellas Park, Florida, United States, 33781
      • Advent Clinical Research Center
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • Saint Petersburg, Florida, United States, 33710
      • St Petersburg General Hospital - X-Rays only
    • Saint Petersburg, Florida, United States, 33713
      • Dale G. Bramlet, MD., P.L.
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • West Palm Beach, Florida, United States, 33417
      • Midtown Imaging
    • West Palm Beach, Florida, United States, 33404
      • Palm Beach Research Center
    • West Palm Beach, Florida, United States, 33409
      • MD Now Urgent Care
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Center for Prospective Outcome Studies
    • Atlanta, Georgia, United States, 30327
      • Southeastern Radiology Associates, LLC
    • Blue Ridge, Georgia, United States, 30513
      • River Birch Research Alliance, Llc
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
    • Marietta, Georgia, United States, 30060
      • CT: Marietta Imaging Center LLC
  • Idaho
    • Boise, Idaho, United States, 83704
      • Selah Medical Center, PA
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center, Llc
    • Evansville, Indiana, United States, 47714
      • Advanced Diagnostic Imaging (ADI)
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Diagnostic Imaging Centers
    • Prairie Village, Kansas, United States, 66206
      • Clinical Trials Technology, Inc.
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinic
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates, Inc.
    • Madisonville, Kentucky, United States, 42431
      • Commonwealth BioMedical Research
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Arthritis and Diabetes Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21239
      • Office of Peter A. Holt, MD
  • Massachusetts
    • Worcester, Massachusetts, United States, 01610
      • Clinical Pharmacology Study Group
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • The Center for Clinical Trials
    • Jackson, Mississippi, United States, 39202
      • Physician's Surgery Center
    • Jackson, Mississippi, United States, 39202
      • Clinical Research Center of Jackson
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Health Research
    • Saint Louis, Missouri, United States, 63117
      • Medex Healthcare Research, Inc.
    • Springfield, Missouri, United States, 65807
      • Clinvest, A Division of Banyan Group, Inc
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium
    • Las Vegas, Nevada, United States, 89119
      • Mirkil Medical
    • Las Vegas, Nevada, United States, 89123
      • Advanced Biomedical Research of America
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
    • Stratford, New Jersey, United States, 08084
      • Booth Radiology
    • Willingboro, New Jersey, United States, 08046
      • CRI Worldwide, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Manlius, New York, United States, 13104
      • Central New York Clinical Research
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • New York, New York, United States, 10004
      • Medex Healthcare Research
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
    • Rochester, New York, United States, 14609
      • B & I Imaging
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
    • Greensboro, North Carolina, United States, 27407
      • Greensboro Imaging
    • Lenoir, North Carolina, United States, 28645
      • Northstate Clinical Research, PLLC
    • Lenoir, North Carolina, United States, 28645
      • Caldwell Memorial Hospital
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Raleigh, North Carolina, United States, 27612
      • Wake Internal Medicine Consultants, Inc.
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73103
      • Health Research of Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Christine Codding, MD
    • Oklahoma City, Oklahoma, United States, 73103
      • McBride Clinic, Inc
  • Oregon
    • Medford, Oregon, United States, 97504
      • Rogue Valley Medical Center
    • Medford, Oregon, United States, 95704
      • Medford Medical Clinic, LLP
    • Medford, Oregon, United States, 97504
      • Sunstone Research
    • Portland, Oregon, United States, 97210
      • Summit Research Network (Oregon), Inc.
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Allegheny Pain Management
    • Altoona, Pennsylvania, United States, 16602
      • Blair Medical Associates-Radiology
    • Bridgeville, Pennsylvania, United States, 15017
      • Paramount Clinical Research
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide LLC
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • New England Center for Clinical Research
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Southern Orthopaedic Sports Medicine
    • Columbia, South Carolina, United States, 29204
      • Columbia Arthritis Center, P.A.
    • Greer, South Carolina, United States, 29651
      • Radiant Research
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Wolf River Medical Group, LLC
    • Germantown, Tennessee, United States, 38138
      • SCRI Research Center, LLC
    • Johnson City, Tennessee, United States, 37601
      • Advanced Therapeutics, Inc.
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Beaumont, Texas, United States, 77701
      • DiscoveResearch, Inc.
    • Beaumont, Texas, United States, 77702
      • Beaumont Internal Medicine & Geriatric Associates
    • Bryan, Texas, United States, 77802
      • DiscoveResearch Incorporated
    • Carrollton, Texas, United States, 75006
      • Punzi Medical Center
    • Dallas, Texas, United States, 75230
      • KRK Medical Research
    • Houston, Texas, United States, 77030
      • Advances in Health, Inc.
    • Houston, Texas, United States, 77065
      • Centex Research
    • Houston, Texas, United States, 77030
      • St. Luke's Diagnostic & Treatment Center Kirby Glen
    • Houston, Texas, United States, 77062
      • Centex Research Inc.
    • Nassau Bay, Texas, United States, 77058
      • Centex Research
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research
    • San Antonio, Texas, United States, 78229
      • Office of Theresia Lee, MD
    • San Antonio, Texas, United States, 78205
      • Paragon Research Center
    • San Antonio, Texas, United States, 78229
      • Sendero Imaging and Treatment Center
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Incorporated/Foothill Family Clinic South
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc.
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Norfolk, Virginia, United States, 23502
      • Chesapeake Regional Imaging Center-Kempsville
    • Norfolk, Virginia, United States, 23502
      • Hampton Road Center for Clinical Research
    • Richmond, Virginia, United States, 23294
      • National Clinical Research - Richmond
    • Virginia Beach, Virginia, United States, 23454
      • Advanced Pain Management
    • Virginia Beach, Virginia, United States, 23454-3033
      • Virginia Beach Radiology
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

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:

• Written informed consent prior to completing any of the study procedures.

• Female patients must meet one of the following criteria:

  1) Female patients of non childbearing potential - Must be post menopausal, defined as women who are >=45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the parent double blind CLBP study; or Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy.

  2.) Female patients of child bearing potential: must not be pregnant or lactating, and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method), and must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing

• Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential.
• Females of child bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the last dose of IV study medication.
• Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures
• Patient has been treated in a parent tanezumab double blind CLBP study
• Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy. At least eight weeks but no more than 12 weeks have elapsed since the last study medication infusion in the parent study. Patients are permitted to enter the extension study up to 12 weeks after their last dose of study medication in their parent study (or 4 weeks after the End of Treatment visit)

Exclusion Criteria:

• Failed screening in a parent tanezumab double blind CLBP study
• Withdrawn from a parent tanezumab double blind CLBP study for an adverse event
• Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to become pregnant during the course of clinical study
• Use of any investigational medication within 30 days prior to Baseline (3 months for any investigational biological other than tanezumab) or plans to receive an investigational medication other than the study medication during the course of this study
• Patients who exited the parent double blind CLBP study because of lack of compliance, protocol violation (including not meeting entrance criteria), no longer willing to participate (for reasons other than lack of efficacy), or were lost to follow up in the parent double blind study
• Patients who were randomized into the parent study in violation of inclusion or exclusion criteria but who were not withdrawn from the parent study;
• Any other condition, which in the opinion of the Investigator, would put the patient at increased safety risk or otherwise make the patient unsuitable for this study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tanezumab 10 mg	Biological: Tanezumab 10 mg; Tanezumab 10 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks
Experimental: Tanezumab 20 mg	Biological: Tanezumab 20 mg; Tanezumab 20 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE: any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state.	Baseline up to 112 days after last dose of study treatment (up to 448 days)
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.	A4091012: Baseline, A4091039: Week 4
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.	A4091012: Baseline, A4091039: Week 8
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.	A4091012: Baseline, A4091039: Week 16
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.	A4091012: Baseline, A4091039: Week 24
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.	A4091012: Baseline, A4091039: Week 32
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.	A4091012: Baseline, A4091039: Week 40
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.	A4091012: Baseline, A4091039: Week 48
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.	A4091012: Baseline, A4091039: Week 56
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4	BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).	A4091012: Baseline, A4091039: Week 4
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8	BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).	A4091012: Baseline, A4091039: Week 8
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16	BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).	A4091012: Baseline, A4091039: Week 16
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24	BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).	A4091012: Baseline, A4091039: Week 24
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32	BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).	A4091012: Baseline, A4091039: Week 32
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40	BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).	A4091012: Baseline, A4091039: Week 40
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48	BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).	A4091012: Baseline, A4091039: Week 48
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56	BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).	A4091012: Baseline, A4091039: Week 56
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4	BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.	A4091012: Baseline, A4091039: Week 4
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8	BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.	A4091012: Baseline, A4091039: Week 8
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16	BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.	A4091012: Baseline, A4091039: Week 16
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24	BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.	A4091012: Baseline, A4091039: Week 24
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32	BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.	A4091012: Baseline, A4091039: Week 32
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40	BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.	A4091012: Baseline, A4091039: Week 40
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48	BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.	A4091012: Baseline, A4091039: Week 48
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 56	BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.	A4091012: Baseline, A4091039: Week 56
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4	RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.	A4091012: Baseline, A4091039: Week 4
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8	RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.	A4091012: Baseline, A4091039: Week 8
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16	RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.	A4091012: Baseline, A4091039: Week 16
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24	RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.	A4091012: Baseline, A4091039: Week 24
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32	RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.	A4091012: Baseline, A4091039: Week 32
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40	RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.	A4091012: Baseline, A4091039: Week 40
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48	RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.	A4091012: Baseline, A4091039: Week 48
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56	RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.	A4091012: Baseline, A4091039: Week 56
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4	Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).	A4091012: Baseline, A4091039: Week 4
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8	Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).	A4091012: Baseline, A4091039: Week 8
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16	Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).	A4091012: Baseline, A4091039: Week 16
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24	Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).	A4091012: Baseline, A4091039: Week 24
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32	Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).	A4091012: Baseline, A4091039: Week 32
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40	Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).	A4091012: Baseline, A4091039: Week 40
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48	Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).	A4091012: Baseline, A4091039: Week 48
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56	Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).	A4091012: Baseline, A4091039: Week 56

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 56
Plasma Concentration of Tanezumab	Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.	Baseline (Day 1), Week 8, 24, 40, 56, 64
Total Nerve Growth Factor (NGF) Concentration		Baseline (Day 1), Week 8, 24, 40, 56, 64

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP)	Food and Drug Administration (FDA) approved analgesics and muscle relaxants were permitted as concomitant medications for CLBP and were prescribed as per investigator's discretion. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drug (NSAIDs), capsaicin products, oral/injectable corticosteroids, and viscosupplementation (eg, hyaluronan).	Baseline up to Week 56
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56	WPAI:SHP: 6-item, binary question on current employment, 3 questions on hours of work and work-loss, 2 questions based on 0-10 point scale to judge how CLBP affects ability to work, perform regular activities(0=no effect on work/activity, 10=completely prevented from working/activity). Four scores derived as percent: activity impairment, impairment while working, overall work impairment, work time missed. Total possible score: 0-100 (0=no impairment/high productivity, 100=completely impaired/low activity). Each of 4 scores expressed as impairment percentages, high percentage=more impairment, less productivity.	A4091012: Baseline, A4091039: Week 24, 56
Number of Participants Who Developed Anti-Tanezumab Antibodies	Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.	Baseline (Day 1), Week 8, 24, 40, 56, 64
Number of Participants With Injection and Infusion Site Reactions	The injection and infusion site reactions were assessed based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after administration (not related to needle insertion pain) of subcutaneous injection or intravenous infusion.	Baseline (Day 1), Week 4, 8, 16, 24, 32 for intravenous infusion; Week 24, 32, 40, 56, 64 for subcutaneous injection
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication	Number of participants are reported based on the maximum number of intravenous (IV) and subcutaneous (SC) doses of tanezumab received.	Day 1 up to Week 56

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
• Gimbel JS, Kivitz AJ, Bramson C, Nemeth MA, Keller DS, Brown MT, West CR, Verburg KM. Long-term safety and effectiveness of tanezumab as treatment for chronic low back pain. Pain. 2014 Sep;155(9):1793-1801. doi: 10.1016/j.pain.2014.06.004. Epub 2014 Jun 14.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2009
• Primary Completion (Actual): November 30, 2010
• Study Completion (Actual): June 22, 2011

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: June 18, 2009
• First Posted (Estimate): June 19, 2009

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: low back pain monoclonal antibody nerve growth factor
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tanezumab
• Other Study ID Numbers: A4091039; CLBP SAFETY EXTENSION OF 1012 (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.