AzTrials
AzTrials

OsteoarthritisPhase 3NCT00809783

Extension Study Of Tanezumab In Osteoarthritis

A Phase 3 study testing tanezumab in people with Osteoarthritis, run by Pfizer at 226 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Osteoarthritis
What is being tested?
tanezumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,147 participants
Where
226 sitesUnited States
Study dates
6 Feb 2009to 23 Jun 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

226 sites in 1 country.

226 sites in 1 country

United States226 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • New Mexico Clinical Research & Osteoporosis Center, Incorporated

    Albuquerque, New Mexico, 87106

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Ann Arbor Clinical Research

    Ann Arbor, Michigan, 48103

  • Pinncale Research Group, LLC

    Anniston, Alabama, 36201

  • Anniston Medical Clinic, PC

    Anniston, Alabama, 36207

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Commonwealth Orthopaedics and Rehabilitation, PC

    Arlington, Virginia, 22205

  • IntegraTrials, LLC

    Arlington, Virginia, 22205

  • Virginia Hospital Center

    Arlington, Virginia, 22205

  • Laureate Clinical Research Group

    Atlanta, Georgia, 30308

  • Arthritis and Rheumatology of Georgia

    Atlanta, Georgia, 30342

  • Laureate Clinical Research Group

    Atlanta, Georgia, 30342

  • Maine Research Associates

    Auburn, Maine, 04210

  • Masters of Clinical Research, Inc.

    Augusta, Georgia, 30909

  • Colorado Orthopedic Consultants, PC

    Aurora, Colorado, 80012

  • Capitol Medical Clinic

    Austin, Texas, 78705

  • Walter F. Chase, MD, PA

    Austin, Texas, 78705

  • Tekton Research, Inc.

    Austin, Texas, 78745

  • Bone and Joint Clinic of Baton Rouge

    Baton Rouge, Louisiana, 70808

  • Gulf Coast Research, LLC

    Baton Rouge, Louisiana, 70808

  • The Baton Rouge Clinic

    Baton Rouge, Louisiana, 70808

  • Stanocola Medical Center

    Baton Rouge, Louisiana, 70816

  • Great Lakes Research Group, Incorporated

    Bay City, Michigan, 48706

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • East Penn Rheumatology Associates, PC

    Bethlehem, Pennsylvania, 18015-1153

  • Osteoporosis Medical Center

    Beverly Hills, California, 90211

  • Greystone Medical Center

    Birmingham, Alabama, 35242

  • Millennium Pain Center

    Bloomington, Illinois, 61701

  • River Birch Research Alliance, LLC

    Blue Ridge, Georgia, 30513

  • Sonora Clinical Research, LLC.

    Boise, Idaho, 83702

  • HeartCare (Private Practice)

    Bradenton, Florida, 34202

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts, 02301

  • Miray Medical Center

    Brockton, Massachusetts, 02301

  • Arthritis and Osteoporosis Medical Associates

    Brooklyn, New York, 11201

  • Providence Clinical Research

    Burbank, California, 91505

  • Peak Anesthesia and Pain Management

    Centennial, Colorado, 80112

  • Low Country Rheumatology, PA

    Charleston, South Carolina, 29406

  • Arthritis and Osteoporosis Consultants of the Carolinas

    Charlotte, North Carolina, 28207-1198

  • Carolina Bone & Joint, PA

    Charlotte, North Carolina, 28210

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Rehabilitation Institute of Chicago

    Chicago, Illinois, 60611

  • eStudySite

    Chula Vista, California, 91911

  • Consultants for Clinical Research Incorporated

    Cincinnati, Ohio, 45219

  • Ohio GI and Liver Institute

    Cincinnati, Ohio, 45219

  • Hilltop Medical Research Center

    Cincinnati, Ohio, 45224

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • Tampa Bay Medical Research, Inc.

    Clearwater, Florida, 33761

  • The Family Healthcare Center, PA

    Clinton, South Carolina, 29325

  • Southern Orthopaedic Sports Medicine

    Columbia, South Carolina, 29204

  • Columbus Clinical Research, Inc.

    Columbus, Ohio, 43213

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • North Texas Joint Care, PA

    Dallas, Texas, 75230

  • Crown Imaging

    Dallas, Texas, 75231

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Radiant Research

    Dallas, Texas, 75231

  • Clinical Research Center of Connecticut

    Danbury, Connecticut, 06810

  • PHP Center for Clinical Research

    Dayton, Ohio, 45439

  • Jefrey D. Lieberman, MD

    Decatur, Georgia, 30033

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Arthritis Associates of South Florida

    Delray Beach, Florida, 33484

  • Delray Research Associates

    Delray Beach, Florida, 33484

  • Denver Internal Medicine Group

    Denver, Colorado, 80209

  • Mountain View Clinical Research, Inc.

    Denver, Colorado, 80209

  • Advanced Orthopedic and Sports Medicine

    Denver, Colorado, 80230

  • In Vivo Clinical Research, Inc

    Doral, Florida, 33166

  • Brandywine Clinical Research

    Downingtown, Pennsylvania, 19335-2620

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • MAPS Applied Research Center Inc.

    Edina, Minnesota, 55435

  • Medical Advanced Pain Specialists

    Edina, Minnesota, 55435

  • Colorado Hematology - Oncology

    Englewood, California, 80110

  • Colorado Orthopedic Consultants, PC

    Englewood, California, 80110

  • American Clinical Research, LLC

    Englewood, Colorado, 80113

  • Orthopaedic Physicians Of Colorado, P.C.

    Englewood, Colorado, 80113

  • University Parks Hematology/Oncology

    Englewood, Colorado, 80113

  • Arthritis Medical Clinic of North County, Inc.

    Escondido, California, 92025

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Odyssey Research

    Fargo, North Dakota, 58104

  • Plains Medical Clinic, LLC

    Fargo, North Dakota, 58104

  • American Health Network

    Fishers, Indiana, 46038

  • S & W Clinical Research

    Fort Lauderdale, Florida, 33306

  • Centre for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida, 33334

  • Early Family Practice Center

    Fort Valley, Georgia, 31030

  • Edinger Medical Group Clinical Research

    Fountain Valley, California, 92708

  • Arthritis Treatment Center

    Frederick, Maryland, 21702

  • Valley Research

    Fresno, California, 93720

  • Northeast Georgia Diagnostic Clinic, LLC

    Gainesville, Georgia, 30501

  • O. David Taunton, Jr, MD

    Grapevine, Texas, 76051

  • Pharmquest

    Greensboro, North Carolina, 27408

  • Diagnostic Center of Medicine

    Henderson, Nevada, 89052

  • Mid-Atlantic Medical Research Centers

    Hollywood, Maryland, 20636

  • St. Joseph's Mercy Clinic

    Hot Springs, Arkansas, 71913

  • Asif Cochinwala, MD, PA

    Houston, Texas, 77008

  • Foundation for Southwest Orthopedic Research

    Houston, Texas, 77030

  • One Step Diagnostic

    Houston, Texas, 77030

  • Southwest Orthopedic Group

    Houston, Texas, 77030

  • The Neurology Center

    Houston, Texas, 77030

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77036

  • Talbert Medical Group

    Huntington Beach, California, 92646

  • Saadat Ansari, MD Office

    Huntsville, Alabama, 35801

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • State of Franklin Healthcare Associates, PLLC

    Johnson City, Tennessee, 37604

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Lakewood Orthopedic Medical & Surgical Group

    Lakewood, California, 90712

  • High Desert Medical Group Research for Life

    Lancaster, California, 93534

  • Independent Clinical Researchers

    Las Vegas, Nevada, 89103

  • Wolfson Medical Center

    Las Vegas, Nevada, 89103

  • Clinical Research Consortium

    Las Vegas, Nevada, 89119

  • Mirkil Medical

    Las Vegas, Nevada, 89119

  • G. Timothy Kelly, MD

    Las Vegas, Nevada, 89128

  • Office of Dr. Danka Michaels, MD

    Las Vegas, Nevada, 89128

  • Delaware Arthritis

    Lewes, Delaware, 19958

  • Pasadena Pharmacy

    Lexington, Kentucky, 40503

  • The Pain Treatment Center of the Bluegrass

    Lexington, Kentucky, 40503

  • Arthritis Center of Lexington

    Lexington, Kentucky, 40504

  • Bluegrass Community Research, Inc

    Lexington, Kentucky, 40515

  • Premiere Clinical Research, LLC

    Long Beach, California, 90807

  • Adult Medicine Specialists

    Longwood, Florida, 32779

  • Genesis Research International

    Longwood, Florida, 32779

  • Samaritan Center for Medical Research

    Los Gatos, California, 95032

  • David H. Neustadt, MD

    Louisville, Kentucky, 40202

  • L-Marc Research Center

    Louisville, Kentucky, 40213

  • Gill Orthopedic Center

    Lubbock, Texas, 79410

  • Robert R. King, M.D.

    Lubbock, Texas, 79410

  • Mansfield Health Center

    Mansfield, Massachusetts, 02048

  • Marietta Rheumatology Associates

    Marietta, Georgia, 30060

  • Clinical Research Advantage, Inc./Mesa Family Medical Center, PC

    Mesa, Arizona, 85203

  • Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC

    Mesa, Arizona, 85206

  • Novara Clinical Research

    Mesa, Arizona, 85206

  • Clinical Research Advantage, Inc.

    Mesa, Arizona, 85213

  • Pharmax Research Clinic, Inc

    Miami, Florida, 33126

  • Kendall South Medical Center, Inc.

    Miami, Florida, 33185

  • Paramount Medical Research and Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • Orthopaedic & Sports Medicine Consultants

    Middletown, Ohio, 45042

  • Signal Point Clinical Research Center

    Middletown, Ohio, 45042

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Horizon Research Group

    Mobile, Alabama, 36608

  • Arthritis and Diabetes Clinic

    Monroe, Louisiana, 71203

  • Koch Family Medicine

    Morton, Illinois, 61550

  • Illinois Bone and Joint Institute, LLC

    Morton Grove, Illinois, 60053

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Medex Healthcare Research

    New York, New York, 10022

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Javed Rheumatology Associates, Inc.

    Newark, Delaware, 19713

  • National Clinical Research - Norfolk, Inc.

    Norfolk, Virginia, 23502

  • Norwalk Medical Group

    Norwalk, Connecticut, 06851

  • Cor Clinical Research, LLC

    Oklahoma City, Oklahoma, 73103

  • Health Research Institute

    Oklahoma City, Oklahoma, 73109

  • Midwest Minor Medical

    Omaha, Nebraska, 68114

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Midwest Minor Medical

    Omaha, Nebraska, 68127

  • Midwest Minor Medical

    Omaha, Nebraska, 68144

  • Sunshine Research Center

    Opa-locka, Florida, 33054-3818

  • Aspen Clinical Research

    Orem, Utah, 84058

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Rheumatology Associates of Central Florida

    Orlando, Florida, 32806

  • The Arthritis Center

    Palm Harbor, Florida, 34684

  • Arizona Arthritis & Rheumatology Research, PLLC

    Paradise Valley, Arizona, 85253

  • Advanced Orthopedic and Sports Medicine

    Parker, Colorado, 80134

  • Arthritis Associates Inc.

    Peabody, Massachusetts, 01960

  • University Clinical Research Incorporated

    Pembroke Pines, Florida, 33024

  • Pivotal Research Center

    Peoria, Arizona, 85381

  • Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC

    Phoenix, Arizona, 85020

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Clinical Research Advantage, Inc.

    Phoenix, Arizona, 85028

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Phoenix, Arizona, 85037

  • Advent Clinical Research Centers, Inc.

    Pinellas Park, Florida, 33781

  • Prem C. Chatpar, MD, LLC

    Plainview, New York, 11803

  • Clinical Investigations of Texas, LLC

    Plano, Texas, 75075

  • Planters Clinic

    Port Gibson, Mississippi, 39150

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Office of Doris M. Rice, MD, FACR

    Portsmouth, Virginia, 23701

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Del Carmen Medical Center

    Reseda, California, 91335

  • HhypotheTest, LLC

    Roanoke, Virginia, 24018

  • AAIR Research Center

    Rochester, New York, 14618

  • The Carolina Center for Rheumatology and Arthritis Care, PA

    Rock Hill, South Carolina, 29732

  • Office of Dr. Andrew Porges

    Roslyn, New York, 11576-1507

  • KMED Research

    Saint Clair Shores, Michigan, 48081

  • Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Incorporated/Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Radiant Research San Antonio Northeast

    San Antonio, Texas, 78217

  • Texas Arthritis Research Center, PA

    San Antonio, Texas, 78217

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Probe Clinical Research, Corp.

    Santa Ana, California, 92701

  • Trinity Clinical Trials

    Santa Ana, California, 92701

  • HeartCare Research

    Sarasota, Florida, 34232

  • Empirical Clinical Trials

    Selah, Washington, 98942

  • Memorial Medical Group Clinical Research Institute

    South Bend, Indiana, 46601

  • Arthritis Northwest

    Spokane, Washington, 99204-2336

  • Spring Family Practice Associates PA

    Spring, Texas, 77379

  • The Arthritis Center

    Springfield, Illinois, 62704

  • St. John's Clinic - Neurology

    Springfield, Missouri, 65804

  • St. John's Medical Research Institute, Inc.

    Springfield, Missouri, 65807

  • Medex Healthcare Research

    St Louis, Missouri, 63117

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Dale G. Bramlet, MD, P.L.

    St. Petersburg, Florida, 33713

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • AZ Clinical Research

    Sugar Land, Texas, 77478

  • Spring Clinical Research

    Sugar Land, Texas, 77478

  • Sugar Land Med-Ped, P.A.

    Sugar Land, Texas, 77479

  • West Broward Rheumatology Associates, Inc.

    Tamarac, Florida, 33321

  • Tampa Medical Group, PA

    Tampa, Florida, 33614

  • SPRI Bronx LLC

    The Bronx, New York, 10454

  • Office of Lawrence P McAdam, MD

    Thousand Oaks, California, 91360

  • Paradigm Clinical, Inc.

    Tucson, Arizona, 85712

  • Quality of Life Medical & Research Center, LLC

    Tucson, Arizona, 85712

  • Quality of Life Medical and Research Center

    Tucson, Arizona, 85712

  • Tucson Orthopaedic Institute

    Tucson, Arizona, 85712

  • University of Arizona

    Tucson, Arizona, 85724

  • Northwest Indiana Center for Clinical Research

    Valparaiso, Indiana, 46383

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Westlake Medical Research

    Westlake Village, California, 91361

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Professional Research Network of Kansas, LLC

    Wichita, Kansas, 67203

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • North Georgia Internal Medicine

    Woodstock, Georgia, 30189

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

  • Clinical Research Center of Reading, LLP

    Wyomissing, Pennsylvania, 19610

  • Clinical Trials Northwest

    Yakima, Washington, 98902

  • Pharmacotherapy Research Associates,Inc

    Zanesville, Ohio, 43701

  • Physicians' Research, Inc

    Zanesville, Ohio, 43701

  • Primecare of Southeastern Ohio, Inc

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions
Osteoarthritis
Being tested
tanezumab
Keywords
Tanezumab OA arthritis
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tanezumabBiological

    Also called RN624

    Tanezumab 10 mg

  • tanezumabBiological

    Also called RN624

    Tanezumab 5 mg

  • tanezumabBiological

    Also called RN624

    Tanezumab 2.5 mg

Study groups in NCT00809783
Study groupRoleWhat they receive
Tanezumab 10 mgExperimentalTanezumab 10 mg
Receives: Biological: tanezumab
Tanezumab 5 mgExperimentalTanezumab 5 mg
Receives: Biological: tanezumab
Tanezumab 2.5 mgExperimentalTanezumab 2.5 mg
Receives: Biological: tanezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: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.

    Measured: A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)

  2. Number of Participants With Abnormal Laboratory Findings

    Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;cholesterol,triglycerides>1.3*ULN;sodium <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN,phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLN or >1.5*ULN,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).

    Measured: A4091016: Day 1 up to Week 80

  3. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings

    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.

    Measured: A4091016: Baseline (Day 1) up to Week 80

Secondary outcomes (17)

  1. Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 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.

    Measured: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  2. Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab

    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.

    Measured: A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)

  3. Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings

    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.

    Measured: Baseline (Day 1) up to Week 80

  4. Number of Participants With Clinically Significant Abnormality in Vital Signs

    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.

    Measured: A4091016: Baseline (Day 1) up to Week 80

  5. 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

    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.

    Measured: 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

  6. 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

    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.

    Measured: 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

  7. 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

    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.

    Measured: 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

  8. Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response

    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).

    Measured: A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104

  9. Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score

    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.

    Measured: 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

  10. 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

    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.

    Measured: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104

  11. Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis

    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.

    Measured: 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

  12. 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

    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.

    Measured: 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

  13. 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

    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.

    Measured: 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

  14. 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

    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.

    Measured: 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

  15. 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

    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.

    Measured: 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

  16. Percentage of Participants Who Used Concomitant Analgesic Medication

    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.

    Measured: 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

  17. Days Per Week of Concomitant Analgesic Medication Usage

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2008 (estimated)
  2. Study start6 Feb 2009
  3. Primary completion2 Nov 2010
  4. Study completion23 Jun 2011

Why it stopped: See termination reason in detailed description.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00809783
Sponsor's protocol ID
A4091016
Other IDs
P3 LONG TERM SAFETY EXTENSION
Status last verified
Apr 2021
First submitted
16 Dec 2008
Last updated
10 May 2021
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

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.

    PubMed 26554876

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tanezumab in people with Osteoarthritis, run by Pfizer at 226 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00809783, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

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