Extension Study Of Tanezumab In Osteoarthritis

April 14, 2021 updated by: Pfizer

A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

Study Overview

Status

Terminated

Conditions

Osteoarthritis

Intervention / Treatment

Detailed Description

This study was terminated on 27 October 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)

2147

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Pinnacle Research Group, LLC
  - Anniston, Alabama, United States, 36207
    - Anniston Medical Clinic, PC
  - Anniston, Alabama, United States, 36201
    - Pinncale Research Group, LLC
  - Birmingham, Alabama, United States, 35242
    - Greystone Medical Center
  - Huntsville, Alabama, United States, 35801
    - Saadat Ansari, MD Office
  - Mobile, Alabama, United States, 36608
    - Horizon Research Group
  - Mobile, Alabama, United States, 36608
    - Coastal Clinical Research, Inc.
- Arizona
  - Mesa, Arizona, United States, 85206
    - Novara Clinical Research
  - Mesa, Arizona, United States, 85213
    - Clinical Research Advantage, Inc.
  - Mesa, Arizona, United States, 85206
    - Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC
  - Mesa, Arizona, United States, 85203
    - Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
  - Paradise Valley, Arizona, United States, 85253
    - Arizona Arthritis & Rheumatology Research, PLLC
  - Peoria, Arizona, United States, 85381
    - Pivotal Research Center
  - Phoenix, Arizona, United States, 85023
    - Arizona Research Center
  - Phoenix, Arizona, United States, 85037
    - Arizona Arthritis & Rheumatology Associates, P.C.
  - Phoenix, Arizona, United States, 85020
    - Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC
  - Phoenix, Arizona, United States, 85028
    - Clinical Research Advantage, Inc.
  - Tucson, Arizona, United States, 85712
    - Quality of Life Medical & Research Center, LLC
  - Tucson, Arizona, United States, 85712
    - Quality of Life Medical and Research Center
  - Tucson, Arizona, United States, 85712
    - Tucson Orthopaedic Institute
  - Tucson, Arizona, United States, 85724
    - University of Arizona
  - Tucson, Arizona, United States, 85712
    - Paradigm Clinical, Inc.
- Arkansas
  - Hot Springs, Arkansas, United States, 71913
    - St. Joseph'S Mercy Clinic
- California
  - Beverly Hills, California, United States, 90211
    - Osteoporosis Medical Center
  - Burbank, California, United States, 91505
    - Providence Clinical Research
  - Chula Vista, California, United States, 91911
    - eStudySite
  - Englewood, California, United States, 80110
    - Colorado Hematology - Oncology
  - Englewood, California, United States, 80110
    - Colorado Orthopedic Consultants, PC
  - Escondido, California, United States, 92025
    - Arthritis Medical Clinic of North County, Inc.
  - Fountain Valley, California, United States, 92708
    - Edinger Medical Group Clinical Research
  - Fresno, California, United States, 93720
    - Valley Research
  - Huntington Beach, California, United States, 92646
    - Talbert Medical Group
  - 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 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
    - Trinity Clinical Trials
  - Santa Ana, California, United States, 92701
    - Probe Clinical Research, Corp.
  - Thousand Oaks, California, United States, 91360
    - Office of Lawrence P McAdam, MD
  - Westlake Village, California, United States, 91361
    - Westlake Medical Research
- Colorado
  - Aurora, Colorado, United States, 80012
    - Colorado Orthopedic Consultants, PC
  - 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.
  - Denver, Colorado, United States, 80230
    - Advanced Orthopedic and Sports Medicine
  - Englewood, Colorado, United States, 80113
    - American Clinical Research, LLC
  - Englewood, Colorado, United States, 80113
    - Orthopaedic Physicians Of Colorado, P.C.
  - Englewood, Colorado, United States, 80113
    - University Parks Hematology/Oncology
  - Parker, Colorado, United States, 80134
    - Advanced Orthopedic and Sports Medicine
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Clinical Research Center of Connecticut
  - Norwalk, Connecticut, United States, 06851
    - Norwalk Medical Group
  - Stamford, Connecticut, United States, 06905
    - Stamford Therapeutics Consortium
- Delaware
  - Lewes, Delaware, United States, 19958
    - Delaware Arthritis
  - Newark, Delaware, United States, 19713
    - Javed Rheumatology Associates, Inc.
- Florida
  - Bradenton, Florida, United States, 34202
    - HeartCare (Private Practice)
  - Clearwater, Florida, United States, 33756
    - Innovative Research of West Florida, Inc.
  - Clearwater, Florida, United States, 33761
    - Tampa Bay Medical Research, Inc.
  - Coral Gables, Florida, United States, 33134
    - Clinical Research of South Florida
  - DeLand, Florida, United States, 32720
    - Avail Clinical Research, LLC
  - Delray Beach, Florida, United States, 33484
    - Arthritis Associates of South Florida
  - Delray Beach, Florida, United States, 33484
    - Delray Research Associates
  - 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
  - Jacksonville, Florida, United States, 32205
    - Westside Center for Clinical Research
  - Longwood, Florida, United States, 32779
    - Adult Medicine Specialists
  - Longwood, Florida, United States, 32779
    - Genesis Research International
  - Miami, Florida, United States, 33185
    - Kendall South Medical Center, Inc.
  - Miami, Florida, United States, 33126
    - Pharmax Research Clinic, Inc
  - Opa-locka, Florida, United States, 33054-3818
    - Sunshine Research Center
  - Orlando, Florida, United States, 32806
    - Compass Research, LLC
  - Orlando, Florida, United States, 32806
    - Rheumatology Associates of Central Florida
  - Palm Harbor, Florida, United States, 34684
    - The Arthritis Center
  - Pembroke Pines, Florida, United States, 33024
    - University Clinical Research Incorporated
  - Pinellas Park, Florida, United States, 33781
    - Advent Clinical Research Centers, Inc.
  - Port Orange, Florida, United States, 32127
    - Progressive Medical Research
  - Saint Petersburg, Florida, United States, 33713
    - Dale G. Bramlet, MD, P.L.
  - Sarasota, Florida, United States, 34232
    - Heartcare Research
  - Tamarac, Florida, United States, 33321
    - West Broward Rheumatology Associates, Inc.
  - Tampa, Florida, United States, 33614
    - Tampa Medical Group, Pa
  - West Palm Beach, Florida, United States, 33409
    - Palm Beach Research Center
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Arthritis and Rheumatology of Georgia
  - Atlanta, Georgia, United States, 30308
    - Laureate Clinical Research Group
  - Atlanta, Georgia, United States, 30342
    - Laureate Clinical Research Group
  - Augusta, Georgia, United States, 30909
    - Masters of Clinical Research, Inc.
  - Blue Ridge, Georgia, United States, 30513
    - River Birch Research Alliance, Llc
  - Decatur, Georgia, United States, 30033
    - Jefrey D. Lieberman, MD
  - Fort Valley, Georgia, United States, 31030
    - Early Family Practice Center
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Diagnostic Clinic, LLC
  - Marietta, Georgia, United States, 30060
    - Marietta Rheumatology Associates
  - Woodstock, Georgia, United States, 30189
    - North Georgia Clinical Research
  - Woodstock, Georgia, United States, 30189
    - North Georgia Internal Medicine
- Idaho
  - Boise, Idaho, United States, 83702
    - Sonora Clinical Research, LLC.
- Illinois
  - Bloomington, Illinois, United States, 61701
    - Millennium Pain Center
  - Chicago, Illinois, United States, 60611
    - Rehabilitation Institute of Chicago
  - Morton, Illinois, United States, 61550
    - Koch Family Medicine
  - Morton Grove, Illinois, United States, 60053
    - Illinois Bone and Joint Institute, LLC
  - Springfield, Illinois, United States, 62704
    - The Arthritis Center
- Indiana
  - Evansville, Indiana, United States, 47714
    - Medisphere Medical Research Center, Llc
  - Fishers, Indiana, United States, 46038
    - American Health Network
  - South Bend, Indiana, United States, 46601
    - Memorial Medical Group Clinical Research Institute
  - Valparaiso, Indiana, United States, 46383
    - Northwest Indiana Center for Clinical Research
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - West Des Moines, Iowa, United States, 50265
    - Integrated Clinical Trial Services, Inc.
- Kansas
  - Wichita, Kansas, United States, 67203
    - Professional Research Network of Kansas, LLC
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - The Pain Treatment Center of the Bluegrass
  - Lexington, Kentucky, United States, 40503
    - Pasadena Pharmacy
  - Lexington, Kentucky, United States, 40504
    - Arthritis Center of Lexington
  - Lexington, Kentucky, United States, 40515
    - Bluegrass Community Research, Inc
  - Louisville, Kentucky, United States, 40213
    - L-MARC Research Center
  - Louisville, Kentucky, United States, 40202
    - David H. Neustadt, MD
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Gulf Coast Research, LLC
  - Baton Rouge, Louisiana, United States, 70808
    - Bone and Joint Clinic of Baton Rouge
  - Baton Rouge, Louisiana, United States, 70816
    - Stanocola Medical Center
  - Baton Rouge, Louisiana, United States, 70808
    - The Baton Rouge Clinic
  - Monroe, Louisiana, United States, 71203
    - Arthritis and Diabetes Clinic
- Maine
  - Auburn, Maine, United States, 04210
    - Maine Research Associates
- Maryland
  - Frederick, Maryland, United States, 21702
    - Arthritis Treatment Center
  - Hollywood, Maryland, United States, 20636
    - Mid-Atlantic Medical Research Centers
  - Wheaton, Maryland, United States, 20902
    - The Center for Rheumatology and Bone Research
- Massachusetts
  - Brockton, Massachusetts, United States, 02301
    - Beacon Clinical Research, LLC
  - Brockton, Massachusetts, United States, 02301
    - Miray Medical Center
  - Mansfield, Massachusetts, United States, 02048
    - Mansfield Health Center
  - Peabody, Massachusetts, United States, 01960
    - Arthritis Associates Inc.
  - Worcester, Massachusetts, United States, 01610
    - Clinical Pharmacology Study Group
- Michigan
  - Ann Arbor, Michigan, United States, 48103
    - Ann Arbor Clinical Research
  - Bay City, Michigan, United States, 48706
    - Great Lakes Research Group, Incorporated
  - Saint Clair Shores, Michigan, United States, 48081
    - KMED Research
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Medical Advanced Pain Specialists
  - Edina, Minnesota, United States, 55435
    - MAPS Applied Research Center Inc.
- Mississippi
  - Port Gibson, Mississippi, United States, 39150
    - Planters Clinic
- Missouri
  - Saint Louis, Missouri, United States, 63141
    - Mercy Health Research
  - Saint Louis, Missouri, United States, 63117
    - Medex Healthcare Research
  - Springfield, Missouri, United States, 65807
    - St. John's Medical Research Institute, Inc.
  - Springfield, Missouri, United States, 65804
    - St. John's Clinic - Neurology
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Quality Clinical Research, Inc.
  - Omaha, Nebraska, United States, 68114
    - Midwest Minor Medical
  - Omaha, Nebraska, United States, 68127
    - Midwest Minor Medical
  - Omaha, Nebraska, United States, 68144
    - Midwest Minor Medical
- Nevada
  - Henderson, Nevada, United States, 89052
    - Diagnostic Center of Medicine
  - Las Vegas, Nevada, United States, 89119
    - Clinical Research Consortium
  - Las Vegas, Nevada, United States, 89119
    - Mirkil Medical
  - Las Vegas, Nevada, United States, 89128
    - Office of Dr. Danka Michaels, MD
  - Las Vegas, Nevada, United States, 89103
    - Independent Clinical Researchers
  - Las Vegas, Nevada, United States, 89103
    - Wolfson Medical Center
  - Las Vegas, Nevada, United States, 89128
    - G. Timothy Kelly, MD
- New Jersey
  - Berlin, New Jersey, United States, 08009
    - Comprehensive Clinical Research
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - New Mexico Clinical Research & Osteoporosis Center, Incorporated
  - Albuquerque, New Mexico, United States, 87102
    - Albuquerque Clinical Trials
- New York
  - Bronx, New York, United States, 10454
    - SPRI Bronx LLC
  - Brooklyn, New York, United States, 11201
    - Arthritis and Osteoporosis Medical Associates
  - New York, New York, United States, 10128
    - The Medical Research Network, LLC
  - New York, New York, United States, 10022
    - Medex Healthcare Research
  - Plainview, New York, United States, 11803
    - Prem C. Chatpar, MD, LLC
  - Rochester, New York, United States, 14618
    - AAIR Research Center
  - Roslyn, New York, United States, 11576-1507
    - Office of Dr. Andrew Porges
- North Carolina
  - Charlotte, North Carolina, United States, 28207-1198
    - Arthritis and Osteoporosis Consultants of the Carolinas
  - Charlotte, North Carolina, United States, 28210
    - Carolina Bone & Joint, PA
  - Greensboro, North Carolina, United States, 27408
    - PharmQuest
  - Winston-Salem, North Carolina, United States, 27103
    - PMG Research of Winston-Salem
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Odyssey Research
  - Fargo, North Dakota, United States, 58104
    - Plains Medical Clinic, LLC
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Ohio GI and Liver Institute
  - Cincinnati, Ohio, United States, 45224
    - Hilltop Medical Research Center
  - Cincinnati, Ohio, United States, 45219
    - Consultants for Clinical Research Incorporated
  - Columbus, Ohio, United States, 43213
    - Columbus Clinical Research, Inc.
  - Dayton, Ohio, United States, 45439
    - PHP Center for Clinical Research
  - Middleburg Heights, Ohio, United States, 44130
    - Paramount Medical Research and Consulting, Llc
  - Middletown, Ohio, United States, 45042
    - Signal Point Clinical Research Center
  - Middletown, Ohio, United States, 45042
    - Orthopaedic & Sports Medicine Consultants
  - Zanesville, Ohio, United States, 43701
    - Pharmacotherapy Research Associates,Inc
  - Zanesville, Ohio, United States, 43701
    - Physicians' Research, Inc
  - Zanesville, Ohio, United States, 43701
    - Primecare of Southeastern Ohio, Inc
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73109
    - Health Research Institute
  - Oklahoma City, Oklahoma, United States, 73103
    - COR Clinical Research, LLC
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015-1153
    - East Penn Rheumatology Associates, Pc
  - Downingtown, Pennsylvania, United States, 19335-2620
    - Brandywine Clinical Research
  - Duncansville, Pennsylvania, United States, 16635
    - Altoona Center for Clinical Research
  - Wyomissing, Pennsylvania, United States, 19610
    - Clinical Research Center of Reading, LLP
- South Carolina
  - Charleston, South Carolina, United States, 29406
    - Low Country Rheumatology, PA
  - 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
  - Rock Hill, South Carolina, United States, 29732
    - The Carolina Center for Rheumatology and Arthritis Care, PA
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Health Concepts
- Tennessee
  - Johnson City, Tennessee, United States, 37604
    - State of Franklin Healthcare Associates, PLLC
  - Kingsport, Tennessee, United States, 37660
    - Holston Medical Group
- Texas
  - Austin, Texas, United States, 78745
    - Tekton Research, Inc.
  - Austin, Texas, United States, 78705
    - Capitol Medical Clinic
  - Austin, Texas, United States, 78705
    - Walter F. Chase, MD, PA
  - Dallas, Texas, United States, 75231
    - Radiant Research
  - Dallas, Texas, United States, 75231
    - Metroplex Clinical Research Center
  - Dallas, Texas, United States, 75230
    - North Texas Joint Care, PA
  - Dallas, Texas, United States, 75231
    - Crown Imaging
  - Grapevine, Texas, United States, 76051
    - O. David Taunton, Jr, MD
  - 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
  - Houston, Texas, United States, 77008
    - Asif Cochinwala, MD, PA
  - Houston, Texas, United States, 77030
    - One Step Diagnostic
  - Houston, Texas, United States, 77036
    - Pioneer Research Solutions, Inc.
  - Lubbock, Texas, United States, 79410
    - Gill Orthopedic Center
  - Lubbock, Texas, United States, 79410
    - Robert R. King, M.D.
  - Plano, Texas, United States, 75075
    - Clinical Investigations of Texas, LLC
  - San Antonio, Texas, United States, 78217
    - Texas Arthritis Research Center, PA
  - San Antonio, Texas, United States, 78229
    - Diagnostics Research Group
  - San Antonio, Texas, United States, 78217
    - Radiant Research San Antonio Northeast
  - Spring, Texas, United States, 77379
    - Spring Family Practice Associates 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
  - Orem, Utah, United States, 84058
    - Aspen Clinical Research
  - Salt Lake City, Utah, United States, 84109
    - 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
    - IntegraTrials, LLC
  - Arlington, Virginia, United States, 22205
    - Commonwealth Orthopaedics and Rehabilitation, PC
  - Charlottesville, Virginia, United States, 22911
    - Charlottesville Medical Research
  - Norfolk, Virginia, United States, 23502
    - National Clinical Research - Norfolk, Inc.
  - Portsmouth, Virginia, United States, 23701
    - Office of Doris M. Rice, MD, FACR
  - Roanoke, Virginia, United States, 24018
    - HhypotheTest, LLC
- Washington
  - Selah, Washington, United States, 98942
    - Empirical Clinical Trials
  - Spokane, Washington, United States, 99204-2336
    - Arthritis Northwest
  - Yakima, Washington, United States, 98902
    - Clinical Trials Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria:

Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tanezumab 10 mg	Biological: tanezumab Tanezumab 10 mg Other Names: RN624 Biological: tanezumab Tanezumab 5 mg Other Names: RN624 Biological: tanezumab Tanezumab 2.5 mg Other Names: RN624
Experimental: Tanezumab 5 mg	Biological: tanezumab Tanezumab 10 mg Other Names: RN624 Biological: tanezumab Tanezumab 5 mg Other Names: RN624 Biological: tanezumab Tanezumab 2.5 mg Other Names: RN624
Experimental: Tanezumab 2.5 mg	Biological: tanezumab Tanezumab 10 mg Other Names: RN624 Biological: tanezumab Tanezumab 5 mg Other Names: RN624 Biological: tanezumab Tanezumab 2.5 mg Other Names: RN624

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) Time Frame: A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)	AE:any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE:an AE resulting in any of following outcomes or deemed significant for any other reason:death;initial or prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent or significant disability/incapacity;congenital anomaly. Treatment-emergent 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. AEs included both SAEs and all non-SAEs.	A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)
Number of Participants With Abnormal Laboratory Findings Time Frame: A4091016: Day 1 up to Week 80	Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8lower limit of normal(LLN),MCV,MCH,MCHC<0.9LLN or >1.1ULN,platelet:<0.5LLN or >1.75upper limit of normal(ULN),white blood cell(WBC):<0.6LLN or >1.5ULN,lymphocyte,neutrophil,total neutrophil:<0.8LLN or>1.2ULN,basophil,eosinophil,monocyte:>1.2ULN;total,direct bilirubin>1.5ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0ULN,total protein,albumin:<0.8LLN or >1.2ULN;blood urea nitrogen,creatinine:>1.3ULN,uric acid>1.2ULN;cholesterol,triglycerides>1.3ULN;sodium <0.95LLN or >1.05ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9LLN or >1.1ULN,phosphate<0.8LLN or>1.2ULN;glucose <0.6LLN or >1.5ULN,glycosylated Hgb >1.3ULN,creatine kinase>2.0ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).	A4091016: Day 1 up to Week 80
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings Time Frame: A4091016: Baseline (Day 1) up to Week 80	Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.	A4091016: Baseline (Day 1) up to Week 80

Secondary Outcome Measures

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Classified According to Number of Intravenous Doses of Study Medication Time Frame: A4091016: Baseline (Day 1) up to Week 64	Number of participants were reported based on the maximum number of intravenous doses of either tanezumab or placebo received.	A4091016: Baseline (Day 1) up to Week 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2009

Primary Completion (Actual)

November 2, 2010

Study Completion (Actual)

June 23, 2011

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria

December 16, 2008

First Posted (Estimate)

December 17, 2008

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Tanezumab OA arthritis

Additional Relevant MeSH Terms

Other Study ID Numbers

A4091016
P3 LONG TERM SAFETY EXTENSION (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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical University of Warsaw

Unknown

Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis

Osteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral Osteoarthritis

Poland
University of California, San Francisco
Stanford University; Robert Wood Johnson Foundation

Completed

Shared Decision Making in Patients With Osteoarthritis of the Hip and Knee (SDM)

Knee Osteoarthritis | Hip Osteoarthritis

United States
University of Vermont

Completed

Mobile Technology to Support Physical Therapy Exercise (MyTherEx)

Osteoarthritis of Knee | Osteoarthritis Of Hip

United States
Hospital for Special Surgery, New York
Royal Infirmary of Edinburgh

Recruiting

Return to Golf After Orthopaedic Surgery

Knee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis

United States, United Kingdom
Ottawa Hospital Research Institute

Not yet recruiting

Regional Anesthesia in Total Hip and Knee Arthroplasty

Knee Osteoarthritis | Hip Osteoarthritis
University Hospital, Lille

Completed

Hip and Knee Scores (HIP-KNEE)

Knee Osteoarthritis | Hip Osteoarthritis

France
Massachusetts General Hospital
Newton-Wellesley Hospital; The New England Baptist Hospital

Completed

Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

Knee Osteoarthritis | Hip Osteoarthritis

United States

Clinical Trials on tanezumab

Pfizer

Terminated

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

Osteoarthritis, Knee | Osteoarthritis, Hip

United States
Pfizer
Eli Lilly and Company

Completed

A Phase 3 Study of Tanezumab for Chronic Low Back Pain (TANGO)

Low Back Pain

United States, Spain, Korea, Republic of, Japan, Canada, Hungary, France, Sweden, Denmark
Pfizer

Terminated

Long Term Safety Study of Tanezumab in Chronic Low Back Pain

Low Back Pain

United States
Pfizer

Completed

A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

Neoplasm Metastasis | Palliative Care

France, United States, Slovakia, Croatia, India, Poland, Austria, Bosnia and Herzegovina, Hungary, Korea, Republic of, Latvia, Mexico, Peru
Pfizer

Terminated

Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

Pain | Arthritis | Osteoarthritis

United States
Pfizer

Completed

Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

Osteoarthritis, Knee | Osteoarthritis, Hip

United States, Puerto Rico, Canada
Pfizer

Completed

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

Osteoarthritis, Knee

Japan
Pfizer

Completed

Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected

Chronic Low Back Pain | Osteoarthritis Pain | Pain Due to Interstitial Cystitis

United States
Pfizer

Completed

Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

Chronic Pain | Osteoarthritis, Knee | Osteoarthritis, Hip

United States, Korea, Republic of, Taiwan, Australia, Serbia, Japan, New Zealand, Philippines, Lithuania, Russian Federation, Croatia, Brazil, Bulgaria, Slovakia, Colombia, Mexico, Peru, Ukraine
Pfizer

Completed

A Study of Tanezumab in Adults With Chronic Low Back Pain

Low Back Pain

United States

Outcome Measure	Measure Description	Time Frame
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	NIS constitutes sum of 37 standard items of neuromuscular examination used to assess muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) scored on a scale: 0 (normal) to 4 (paralysis), with higher score=more weakness; components of reflexes and sensation (13 items) scored on a scale: 0= normal, 1= decreased or 2= absent. Total NIS score range 0 (no impairment) to 244 (maximum impairment), higher score = more impairment. Parent study baseline value calculated as average of pre-dose measurements of participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab Time Frame: A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)	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.	A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)
Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings Time Frame: Baseline (Day 1) up to Week 80	Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat and thyroid. Clinically significant changes were judged by investigator.	Baseline (Day 1) up to Week 80
Number of Participants With Clinically Significant Abnormality in Vital Signs Time Frame: A4091016: Baseline (Day 1) up to Week 80	Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs were judged by investigator and reported as adverse events were presented.	A4091016: Baseline (Day 1) up to Week 80
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC physical function score is 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 indicate worse function. Total score range for WOMAC physical function subscale score is 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicate worse condition. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response Time Frame: A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104	OMERACT-OARSI response:>=50 percent(%) improvement from parent study baseline and absolute change from parent study baseline of >=2 units at given week in WOMAC pain or physical function subscale or >=20% improvement from parent study baseline and absolute change from parent study baseline of >=1 unit at given week in at least 2 of following 3 items: 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).	A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104 Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicated worse pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	WOMAC stiffness subscale: questionnaire used to assess amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. The WOMAC stiffness score is calculated as mean of scores from 2 individual questions scored on NRS of 0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score =0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Stiffness is defined as sensation of decreased ease in movement of knee/hip. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	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. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (minimum difficulty) to 10 (maximum difficulty), where higher score indicates worse response. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	Participants answered: "How much pain have you had going up or down the stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 Time Frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Percentage of Participants Who Used Concomitant Analgesic Medication Time Frame: Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112	United States Food and Drug Administration (FDA) approved analgesics (over-the-counter or prescription) 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, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed as per investigator's discretion.	Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112
Days Per Week of Concomitant Analgesic Medication Usage Time Frame: Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112	FDA approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, NSAIDs, capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed at the discretion of the investigator.	Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112

Extension Study Of Tanezumab In Osteoarthritis

A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

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