Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip

A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF THE LONG-TERM ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ALONE OR IN COMBINATION WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) VERSUS NSAIDS ALONE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.

Study Overview

• Status: Terminated
• Conditions: Arthritis; Osteoarthritis
• Intervention / Treatment: Drug: NSAID; Drug: NSAID; Biological: tanezumab; Biological: tanezumab; Biological: tanezumab; Biological: tanezumab

Detailed Description

This study was terminated on 28 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): 2720
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 3M7
    • Groupe de Recherche en Rhumatologie et Maladies Osseuses
  • Quebec, Canada, G1W 4R4
    • Clinique Médicale St-Louis
  • Nova Scotia
    • Lunenburg, Nova Scotia, Canada, B0J 2C0
      • Office of Diane Wilson
  • Ontario
    • Hamilton, Ontario, Canada, L8N 2B6
      • MAC Research Inc.
    • Kitchener, Ontario, Canada, N2M 5N6
      • KW Musculoskeletal Research Inc.
    • Newmarket, Ontario, Canada, L3Y 5G8
      • SKDS Research Inc.
    • Newmarket, Ontario, Canada, L3Y 3R7
      • The Arthritis Program Research Group
    • St. Catharines, Ontario, Canada, L2N 7E4
      • Dr. Saeed Shaikh
    • Toronto, Ontario, Canada, M9V 4B4
      • Dr. Anil Gupta
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
    • St. Eustache, Quebec, Canada, J7P 4J2
      • Polyclinique St. Eustache
    • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
      • Centre de Recherche Musculo-Squelettique
• Colombia
  • Bogota-Cundinamarca, Colombia
    • Riesgo de Fractura S.A.
  • Medellin, Colombia
    • Clínica Las Américas
  • Medellin, Colombia
    • Reumatologya S.A.
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Hospital Pablo Tobón Uribe
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Centro Integral de Reumatologia e Inmunologia CIREI
• India
  • Andhra Pradesh
    • Secunderabad, Andhra Pradesh, India, 500003
      • Krishna Institute of Medical Sciences Ltd., Department of Rheumatology
  • Karnataka
    • Bangalore, Karnataka, India, 560034
      • St. Johns Medical College Hospital, Department of Orthopaedics
    • Bangalore, Karnataka, India, 560054
      • M.S. Ramaiah Memorial Hospital, Department of Orthopaedics
    • Bangalore, Karnataka, India, 560079
      • Chanre Rheumatology & Immunology Center & Research
    • Mangalore, Karnataka, India, 575 001
      • KMC Hospital, Department of Orthopaedics
  • Maharashtra
    • Pune, Maharashtra, India, 411 005
      • Sancheti Hospital
  • Tamilnadu
    • Coimbatore, Tamilnadu, India, 641004
      • PSG Institute of Medical Sciences and Research
  • UP
    • Lucknow, UP, India, 226018
      • CSM Medical University, Department of Rheumatology
• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital
  • Incheon, Korea, Republic of, 400-711
    • Inha University Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 133-792
    • Hanyang University Hospital
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea, Seoul St.Mary's Hospital
• Mexico
  • Coahuila, Mexico, 27000
    • Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C.
  • Culiacan Sinaloa, Mexico, CP 80230
    • Hospital General de Culiacan, S.S., "Dr. Bernardo Gastelum".
  • Leon Gto, Mexico, C.P. 37000
    • Hospital Aranda de La Parra
  • Torreon Coahuila, Mexico, CP 27000
    • Beneficencia Espanola de la Laguna
  • Jalisco
    • Guadalajara, Jalisco, Mexico, CP 44280
      • URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de Guadalajara"Fray Antonio Alcalde"
• Netherlands
  • Amsterdam, Netherlands, 1056 AB
    • Reade
  • Nijmegen, Netherlands, 6525 GA
    • UMC St. Radboud
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht
• Philippines
  • Cebu City, Philippines, 6000
    • Cebu Orthopedic Institute
  • Cebu City, Philippines, 6000
    • Chong Hua Hospital, Medical Arts Center
  • Cebu City, Philippines, 6000
    • Diaz Building
  • Davao City, Philippines, 8000
    • Davao Doctors Hospital
  • Davao City, Philippines, 8000
    • Davao Doctors Hospital, Medical Tower
  • Manila, Philippines, 1003
    • Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center
  • Manila, Philippines
    • Chinese General Hospital and Medical Center, Out Patient Department
  • Muntinlupa, Philippines, 1780
    • Asian Hospital and Medical Center
• Russian Federation
  • Moscow, Russian Federation, 115093
    • State Healthcare Institution Moscow City Clinical Hospital #4
  • Moscow, Russian Federation, 115446
    • State Healthcare Institution: Moscow City Clinical Hospital #7
  • Moscow, Russian Federation, 115522
    • Institution of Russian Academy of Medical Sciences
  • Saint Petersburg, Russian Federation, 197022
    • Saint Petersburg State Medical University named after Pavlov
  • Saint-Petersburg, Russian Federation, 194291
    • Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov
  • Saint-Petersburg, Russian Federation, 196247
    • Saint-Petersburg State Healthcare Institution "City Hospital #26"
• South Africa
  • Bellville, South Africa
    • Tiervlei Trial Center
  • Benoni, South Africa, 1500
    • Worthwhile Clinical Trials
  • Bloemfontein, South Africa, 9301
    • Josha Research
  • Cape Town, South Africa, 7405
    • Vincent Pallotti Hospital
  • Durban, South Africa, 4091
    • Private practice
  • Durban, South Africa, 4091
    • Randles Road Medical Center
  • Durbanville, South Africa, 7550
    • A. Briel
  • Johannesburg, South Africa, 2060
    • Origin Clinical Research
  • Kempton Park, South Africa, 1619
    • Clinresco Centres (Pty) Ltd
  • Paarl, South Africa, 7646
    • Paarl Research Center
  • Parrowvalley, South Africa, 7500
    • TREAD Research
  • Pretoria, South Africa, 0083
    • Clinical Research Unit
  • Cape Town
    • Panorama, Cape Town, South Africa, 7500
      • 136 Panorama Medical Center
  • Pretoria
    • Mamelodi East, Pretoria, South Africa, 0122
      • Phelang Private Hospital Research Unit
• Spain
  • A Coruna, Spain, 15006
    • Complejo Hospitalario Universitario de a Coruna
  • Barakaldo (Vizcaya), Spain, 48903
    • Hospital de Cruces, Servicio de Reumatologia
  • Barcelona, Spain, 08034
    • Clínica CIMA
  • Barcelona, Spain, 08034
    • Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz, Servicio de Reumatologia
  • Santiago De Compostela, A Coruna, Spain, 15705
    • Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia
  • Sevilla, Spain, 41014
    • Hospital Nuestra Senora de Valme, Servicio de Reumatologia
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia
  • Sevilla
    • Dos Hermanas, Sevilla, Spain, 41700
      • Hospital El Tomillar
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • Chernivtsi Regional Clinical Hospital
  • Donetsk, Ukraine, 83000
    • City Clinical Hospital #5
  • Donetsk, Ukraine, 83045
    • V.K. Gusak Institute of Urgent and Recovery Surgery
  • Kiev, Ukraine, 04114
    • State Institution "Institute of Gerontology AMS of Ukraine"
  • Kiev, Ukraine, 01601
    • Kiev City Oleksandrivska Clinical Hospital
  • Kiev, Ukraine, 02125
    • Kiev City Clinical Hospital #3
  • Kiev, Ukraine, 03115
    • State Institution "Research Centre for Radiation Medicine AMS of Ukraine"
  • Zaporizhzhya, Ukraine, 69600
    • Municipal institution :Zaporizhzhya Regional Clinical Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Radiant Research
    • Birmingham, Alabama, United States, 35215
      • Alliance Clinical Research
    • Birmingham, Alabama, United States, 35205
      • Rheumatology Associates, P.C.
    • Birmingham, Alabama, United States, 35216
      • Shades Mountain Imaging
    • Huntsville, Alabama, United States, 35801
      • Rheumatology Associates of North Alabama, PC
    • Huntsville, Alabama, United States, 35801
      • Saadat Ansari, MD Office
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
    • Montgomery, Alabama, United States, 36117
      • Office of Vaughn H. Mancha, Jr., MD
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Radiant Research - Phoenix Southeast
    • Goodyear, Arizona, United States, 85395
      • Dedicated Clinical Research
    • Green Valley, Arizona, United States, 85614
      • Eclipse Clinical Research
    • Lake Havasu City, Arizona, United States, 86403
      • Midwest Internal Medicine, PLLC
    • Mesa, Arizona, United States, 85210
      • Pivotal Research Centers
    • Mesa, Arizona, United States, 85202
      • Arizona Arthritis & Rheumatology Associates, P.C.
    • Paradise Valley, Arizona, United States, 85253
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Peoria, Arizona, United States, 85381
      • Pivotal Research Centers
    • Phoenix, Arizona, United States, 85037
      • Arizona Arthritis & Rheumatology Associates, P.C.
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies, LLC
    • Sierra Vista, Arizona, United States, 85635
      • Cochise Clinical Research
    • Tempe, Arizona, United States, 85282
      • Premiere Phamaceutical Research, 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, 85710
      • Radiant Research
    • Tucson, Arizona, United States, 85712-2142
      • Arizona Research Associates
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Family Practice Clinic
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Diagnostic Clinic, PA
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Anaheim, California, United States, 92801
      • Orange County Clinical Trials, Inc.
    • Carmichael, California, United States, 95608
      • Med Center
    • Chula Vista, California, United States, 91911
      • eStudySite
    • Fair Oaks, California, United States, 95628
      • Med Investigations, Inc.
    • La Mesa, California, United States, 91942
      • TriWest Research
    • Lakewood, California, United States, 90712
      • Lakewood Orthopedic Medical & Surgical Group
    • Lakewood, California, United States, 90712
      • Premier Clinical Research LLC.
    • Long Beach, California, United States, 90808
      • ProHealth Partners
    • Los Angeles, California, United States, 90025
      • Peak Health Medical Group, Inc.
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • Oceanside, California, United States, 92056
      • eStudySite
    • Palm Springs, California, United States, 92262
      • Desert Medical Group Inc., Desert Oasis Healthcare
    • Rancho Mirage, California, United States, 92270
      • Advances in Medicine
    • Sacramento, California, United States, 95823
      • Mercy Imaging Center
    • Sacramento, California, United States, 95831
      • Northern Clinical Research
    • San Diego, California, United States, 92108
      • San Diego Arthritis Medical Clinic
    • San Diego, California, United States, 92103-6204
      • California Research Foundation
    • San Francisco, California, United States, 94118
      • Kaiser Permanente Medical Center
    • San Jose, California, United States, 95124
      • eStudySite
    • Santa Ana, California, United States, 92701
      • Trinity Clinical Trials
    • Santa Ana, California, United States, 92705
      • Apex Research Institute
    • Stockton, California, United States, 95204
      • St. Joseph Medical Associates
    • Westlake Village, California, United States, 91361
      • Westlake Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Lynn Institute of the Rockies
    • Colorado Springs, Colorado, United States, 80909
      • Colorado Springs Family Practice
    • Englewood, Colorado, United States, 80113
      • Colorado Arthritis Center, PC
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Joao MA Nascimento, MD
    • Trumbull, Connecticut, United States, 06611
      • New England Research Associates, LLC
  • Delaware
    • Lewes, Delaware, United States, 19958
      • Rheumatology Consultants of Delaware/Delaware Arthritis
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis and Rheumatic Disease Specialties
    • Aventura, Florida, United States, 33180
      • Surgery Center of Aventura
    • Aventura, Florida, United States, 33180
      • International Physicans Research
    • Bradenton, Florida, United States, 34202
      • HeartCare
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • Crystal River, Florida, United States, 34429
      • Nature Coast Clinical Research
    • Cutler Bay, Florida, United States, 33189
      • Homestead Clinical Research Group, P.A.
    • Daytona Beach, Florida, United States, 32117
      • Covance Cru, Inc.
    • Dunedin, Florida, United States, 34698
      • Robert W. Levin MD
    • Fort Myers, Florida, United States, 33916
      • Clinical Physiology Associates, Clinical Study Center
    • Fort Myers, Florida, United States, 33912
      • Internal Medicine Associates
    • Hialeah, Florida, United States, 33012
      • Palm Springs Research Institute
    • Hialeah, Florida, United States, 33010
      • Research Consultants Group
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Lake Mary, Florida, United States, 32746
      • Florida Arthritis
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic, Inc.
    • Miami, Florida, United States, 33155
      • Community Research Foundation
    • Naples, Florida, United States, 34102
      • Jeffrey Alper MD Research
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocala, Florida, United States, 34471
      • American Family Medicine
    • Opa-locka, Florida, United States, 33054-3818
      • Sunshine Research Center
    • Orlando, Florida, United States, 32804
      • Arthritis Associates
    • Palm Harbor, Florida, United States, 34684
      • Arthritis Research Of Florida, Inc.
    • Pembroke Pines, Florida, United States, 33024
      • University Clinical Research
    • Pemkbroke Pines, Florida, United States, 33028
      • Pembroke Clinical Trials
    • Pinellas Park, Florida, United States, 33781
      • Advent Clinical Research Centers
    • Pinellas Park, Florida, United States, 33781
      • Advent Clinical Research Center Inc
    • Plantation, Florida, United States, 33324
      • Berma Research Group
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Saint Petersburg, Florida, United States, 33713
      • Dale G. Bramlet, MD, P.L.
    • Sarasota, Florida, United States, 34233
      • Lovelace Scientific Resources
    • Sarasota, Florida, United States, 34232
      • Kennedy-White Orthopaedic Center
    • Sarasota, Florida, United States, 34232
      • Heartcare Research
    • Sarasota, Florida, United States, 34232
      • Sarasota Center for Clinical Research
    • Sarasota, Florida, United States, 34233
      • The Arthritis Specialty Centre
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Tampa, Florida, United States, 33614
      • Tampa Medical Group, PA
    • Tampa, Florida, United States, 33609-3018
      • Soutwest Florida Clinical Research Center
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, PA
  • Georgia
    • Atlanta, Georgia, United States, 30338
      • Perimeter Institute for Clinical Reseach, Inc.
    • Atlanta, Georgia, United States, 30342
      • Laureate Clinical Research Group
    • Roswell, Georgia, United States, 30075
      • ACCR/Internal Medicine
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Institute of Arthritis Research
    • Meridian, Idaho, United States, 83642-6356
      • Idaho Arthritis & Osteoporosis Center, PC
    • Nampa, Idaho, United States, 83686
      • Saltzer Medical Group PA
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago
    • Rockford, Illinois, United States, 61107
      • Rockford Orthopedic Associates
    • Springfield, Illinois, United States, 62702
      • Springfield Clinic
    • Springfield, Illinois, United States, 62703
      • Springfield Clinical Research Department
    • Vernon Hills, Illinois, United States, 60061
      • Deerbrook Medical Associates
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network of Indiana, LLC
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trial Services, Inc
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince and Associates Clinical Research
    • Overland Park, Kansas, United States, 66211
      • Vince and Associates Clinical Research
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Center For Arthritis and Osteoporosis
    • Lexington, Kentucky, United States, 40503
      • Pasadena Pharmacy
    • Lexington, Kentucky, United States, 40503
      • Pain Treatment Center of the Bluegrass
    • Madisonville, Kentucky, United States, 42431
      • Commonwealth Biomedical Research, LLC
    • Madisonville, Kentucky, United States, 42431
      • Multicare Specialists
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Gulf Coast Research, LLC
    • Baton Rouge, Louisiana, United States, 70808
      • The Bone and Joint Clinic
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • MD Medical Research
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research
    • Pittsfield, Massachusetts, United States, 01201
      • Berkshire Rheumatology
    • Watertown, Massachusetts, United States, 02472
      • MedVadis Research Corporation
  • Michigan
    • Bingham Farms, Michigan, United States, 48025
      • Quest Research Institute
    • Kalamazoo, Michigan, United States, 49009
      • Rheumatology Pc
    • Lansing, Michigan, United States, 48917
      • PCM Medical Services
    • Lansing, Michigan, United States, 48910-8595
      • Justus J Fiechtner, MD
    • Traverse City, Michigan, United States, 49684
      • Medical Research Associates
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • The Center for Clinical Trials
    • Olive Branch, Mississippi, United States, 38654
      • Olive Branch Family Medical Center
    • Picayune, Mississippi, United States, 39466
      • Highland Community Hospital
    • Picayune, Mississippi, United States, 39466
      • Mississippi Medical Research
  • Missouri
    • Florissant, Missouri, United States, 63031
      • No. County Internal Medicine & Rheumatology
    • Kansas City, Missouri, United States, 64114
      • Dynamic Clinical Research, Inc.
    • Kansas City, Missouri, United States, 64114
      • Joan Prouty Moore
    • Kansas City, Missouri, United States, 64114
      • Orthopaedic & Occupational Medicine
    • Saint Louis, Missouri, United States, 63117
      • Medex Healthcare Research, Inc.
    • Saint Louis, Missouri, United States, 63141
      • A & A Pain Institute
    • Saint Louis, Missouri, United States, 63131
      • Rheumatology and Internal Medicine Associates of West County, P.C.
    • Saint Louis, Missouri, United States, 63141
      • Arthritis Consultants Inc.
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC
    • Omaha, Nebraska, United States, 68114
      • Westroads Medical Group
  • New Jersey
    • Edison, New Jersey, United States, 08817
      • Anderson and Collins Clinical Research Inc.
    • Elizabeth, New Jersey, United States, 07202
      • Central Jersey Medical Research Center
    • Freehold, New Jersey, United States, 07728
      • Arthritis & Osteoporosis Associates, P.A.
    • Haddon Heights, New Jersey, United States, 08035
      • Mark Fisher, MD, FACRUC
    • Passaic, New Jersey, United States, 07055
      • New Jersey Physicians, LLC
    • Teaneck, New Jersey, United States, 07666
      • Rheumatology Associates of North Jersey
    • Toms River, New Jersey, United States, 08757
      • Arthritis & Osteoporosis Associates
    • Trenton, New Jersey, United States, 08611
      • Premier Research
    • Voorhees, New Jersey, United States, 08043
      • Arthritis, Rheumatic & Back Disease Associates
  • New York
    • Albany, New York, United States, 12206
      • The Center For Rheumatology, Llp
    • Bronx, New York, United States, 10454
      • SPRI Bronx LLC
    • Brooklyn, New York, United States, 11201
      • Arthritis and Osteoporosis Associates of Brooklyn Heights
    • New York, New York, United States, 10003
      • NYU Hospital for Joint Diseases
    • Plainview, New York, United States, 11803
      • Prem C. Chatpar, MD, LLC
    • West Seneca, New York, United States, 14224
      • Southgate Medical Group
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physicians East, PA
    • Greenville, North Carolina, United States, 27834
      • Physicians East P. A.
    • Hickory, North Carolina, United States, 28601
      • Clinical Trials of America, Inc
    • Hickory, North Carolina, United States, 28602
      • Piedmont Rheumatology
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Raleigh, North Carolina, United States, 27612
      • Wake Internal Medicine Consultants Inc
    • Salisbury, North Carolina, United States, 28144
      • Crescent Medical Research
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Lillestol Research, LLC
    • Fargo, North Dakota, United States, 58103
      • Internal Medicine Associates
  • Ohio
    • Akron, Ohio, United States, 44313
      • DayStar Clinical Research, Inc.
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
    • Cincinnati, Ohio, United States, 45246
      • Sterling Research Group
    • Cincinnati, Ohio, United States, 45246
      • Doctor's Urgent Care Offices
    • Columbus, Ohio, United States, 43213
      • Columbus Clinical Research, Inc.
    • Columbus, Ohio, United States, 43235
      • Optimed Research, LTD
    • Dayton, Ohio, United States, 45432
      • Hometown Urgent Care and Research
    • Dayton, Ohio, United States, 45408
      • STAT Research, Inc.
    • Dayton, Ohio, United States, 45415
      • Dayton Science Institute (DSI)
    • Dayton, Ohio, United States, 45439
      • PHP - Center for Clinical Research
    • Mayfield, Ohio, United States, 44143
      • David R. Mandel, MD, Inc
    • Middleburg Heights, Ohio, United States, 44130
      • Southwest Rheumatology and Research Group, LLC
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
    • Norman, Oklahoma, United States, 73069
      • Lion Research
    • Norman, Oklahoma, United States, 73069
      • Integris Family Care of Norman
    • Norman, Oklahoma, United States, 73071
      • Elise Wiesner, MD
    • Norman, Oklahoma, United States, 73072
      • McBride Clinic, Inc
    • Norman, Oklahoma, United States, 73072
      • McBride Clinic
    • 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, 73119
      • Hillcrest Clinical Research
    • Oklahoma City, Oklahoma, United States, 73103
      • Christine Codding, MD
    • Oklahoma City, Oklahoma, United States, 73013
      • McBride Clinic, Inc
    • Oklahoma City, Oklahoma, United States, 73103
      • Bone and Joint Hospital at St. Anthony
    • Oklahoma City, Oklahoma, United States, 73103
      • Mc Bride Clinic
    • Oklahoma City, Oklahoma, United States, 73119
      • Associated Orthopedics, Inc.
    • Tulsa, Oklahoma, United States, 74136
      • Rheumatology Associates Inc
    • Yukon, Oklahoma, United States, 73099
      • Aquilo Clinical Research
  • Oregon
    • Bend, Oregon, United States, 97701
      • Bend Memorial Clinic
    • Bend, Oregon, United States, 97702
      • Bend Memorial Clinic
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Blair Orthopedics Associates
    • Pittsburgh, Pennsylvania, United States, 15206
      • Clinical Trials Research Services, LLC
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Clinton, South Carolina, United States, 29325
      • The Family Healthcare Center, PA
    • 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 Inc
    • Rock Hill, South Carolina, United States, 29732
      • The Carolina Center for Rheumatology and Arthritis Care, PA
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Regional Health Clinical Research
    • Rapid City, South Dakota, United States, 57701
      • Regional Medical Clinical-Rheumatology
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Arthritis Clinic
    • Memphis, Tennessee, United States, 38119
      • Ramesh C. Gupta, M.D.
  • Texas
    • Abilene, Texas, United States, 79601
      • Abilene Arthritis Center
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc.
    • Austin, Texas, United States, 78746
      • Dr. Paul K. Pickrell (Physician's Office)
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Houston, Texas, United States, 77034
      • Accurate Clinical Research
    • Houston, Texas, United States, 77030
      • One Step Diagnostic
    • Houston, Texas, United States, 77055
      • Miracle Medical Center
    • Houston, Texas, United States, 77070
      • DM Clinical Research
    • Lubbock, Texas, United States, 79410
      • Gill Orthopedic Center
    • Lubbock, Texas, United States, 79410
      • Robert R. King, M.D.
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology, PA
    • New Braunfels, Texas, United States, 78130
      • Hill Country Medical Associates
    • New Braunfels, Texas, United States, 78130
      • Neurology Clinic of Central Texas
    • Pasadena, Texas, United States, 77504
      • Philip Blum
    • Pearland, Texas, United States, 77584
      • Pearland Primary Care Associates
    • Pearland, Texas, United States, 77584
      • Southwest Clinical Research Centers, Llc
    • Plano, Texas, United States, 75075
      • Plano Primary Care Clinic
    • Plano, Texas, United States, 75093
      • Advanced Family Medical Care
    • San Antonio, Texas, United States, 78217
      • Texas Arthritis Research Center, PA
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78229
      • Sam Clinical Research Center
    • San Antonio, Texas, United States, 78229
      • Innovative Clinical Trials
    • San Antonio, Texas, United States, 78229
      • Radiant Research San Antonio
    • San Antonio, Texas, United States, 78212
      • Alamo Clinical Research Associates
    • San Antonio, Texas, United States, 78212
      • Alamo Clinical Research Consultants
    • San Antonio, Texas, United States, 78229
      • San Antonio Preventive & Diagnostic Medicine, PA
    • San Antonio, Texas, United States, 78229
      • South Texas Radiology Imaging Center
    • San Antonio, Texas, United States, 78229
      • The Rehab Group
    • Sugar Land, Texas, United States, 77479
      • Sugar Land Med-Ped, PA
    • Temple, Texas, United States, 76508
      • Scott & White Healthcare
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic
  • Utah
    • Midvale, Utah, United States, 84047
      • Pivotal Research Centers
    • Salt Lake City, Utah, United States, 84102
      • Optimum Clinical Research, Inc.
    • Salt Lake City, Utah, United States, 84107
      • Radiant Research, Inc.
  • Virginia
    • Portsmouth, Virginia, United States, 23701
      • Doris M. Rice, M.D., F.A.C.R.
    • Richmond, Virginia, United States, 23294
      • National Clinical Research Richmond Inc.
    • Roanoke, Virginia, United States, 24018
      • Hypothe Test, LLC
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Tacoma, Washington, United States, 98405-2308
      • Tacoma Center for Arthritis Research, PS
  • Wisconsin
    • Onalaska, Wisconsin, United States, 54650
      • Gundersen Clinic Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.
• Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
• Pain level and function levels as required by the protocol at Screening and Baseline.
• Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol.
• Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

• Pregnant women.
• BMI greater than 39.
• Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA.
• Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening.
• Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
• History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
• At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women).
• Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
• Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: IV Placebo + NSAID; Oral NSAID	Drug: NSAID; IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks; Drug: NSAID; Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
EXPERIMENTAL: Tanezumab 5 mg; IV tanezumab 5 mg every 8 weeks (through Week 48)	Biological: tanezumab; IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56; Biological: tanezumab; IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56; Biological: tanezumab; IV tanezumab 5 mg every 8 weeks (through Week 48); Biological: tanezumab; IV tanezumab 10 mg every 8 weeks (through Week 48)
EXPERIMENTAL: Tanezumab 10 mg; IV tanezumab 10 mg every 8 weeks (through Week 48)	Biological: tanezumab; IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56; Biological: tanezumab; IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56; Biological: tanezumab; IV tanezumab 5 mg every 8 weeks (through Week 48); Biological: tanezumab; IV tanezumab 10 mg every 8 weeks (through Week 48)
EXPERIMENTAL: Tanezumab 5 mg + NSAID; IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks	Drug: NSAID; IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks; Drug: NSAID; Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks; Biological: tanezumab; IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56; Biological: tanezumab; IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56; Biological: tanezumab; IV tanezumab 5 mg every 8 weeks (through Week 48); Biological: tanezumab; IV tanezumab 10 mg every 8 weeks (through Week 48)
EXPERIMENTAL: Tanezumab 10 mg + NSAID; IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks	Drug: NSAID; IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks; Drug: NSAID; Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks; Biological: tanezumab; IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56; Biological: tanezumab; IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56; Biological: tanezumab; IV tanezumab 5 mg every 8 weeks (through Week 48); Biological: tanezumab; IV tanezumab 10 mg every 8 weeks (through Week 48)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Week 16
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.	Baseline, Week 16
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16	Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 12, and 24
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.	Baseline, Weeks 2, 4, 8, 12, and 24
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.	Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)	Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.	Baseline, Weeks 2, 4, 8, 12, and 24
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)	Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.	Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)	Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).	Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)	Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).	Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30%, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.	Baseline, Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30 percent, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.	Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.	Baseline, Week 16
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.	Baseline, Week 16
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)	Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.	Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF)	Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.	Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.	Baseline, Weeks 2, 4, 8, 12, 16, and 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.	Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.	Baseline, Weeks 2, 4, 8, 12, 16, and 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.	Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 12, 16, and 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 12, 16, and 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)	The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.	Baseline, Weeks 12 and 24
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)	The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.	Baseline, Weeks 12, 24, 40, and 56
Number of Participants Who Had Discontinued Study Due to Lack of Efficacy		Baseline up to Week 56
Time to Discontinuation Due to Lack of Efficacy	Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.	Baseline up to Week 56
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)	The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.	Baseline, Week 24
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)	The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.	Baseline, Week 24 and 56
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)	The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.	Baseline, Week 24
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)	The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.	Baseline, Weeks 24 and 56
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF	The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.	Baseline, Week 24
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF	The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.	Baseline, Weeks 24 and 56
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)	The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.	Baseline, Week 24
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)	The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.	Baseline, Weeks 24, and 56
Percentage of Participants Who Used Rescue Medication: Observed Data	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.	Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.	Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56
Amount of Rescue Medication Used	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized.	Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56
Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56		Baseline, Week 56
Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56		Baseline, Week 56
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.	Baseline up to Week 64
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data	The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.	Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)	The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.	Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Plasma Trough (Pre-dose) Concentration of Tanezumab		Predose on Day 1, Weeks 16, 24, 40, and 56
Number of Participants With Intravenous (IV) Doses of Study Medication	Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.	Baseline up to Week 48

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Anti-Drug Antibody (ADA) Response	Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for tanezumab were considered ADA positive.	Baseline, Weeks 16, 40, 24, and 56
Number of Participants With Positive Urine or Serum Pregnancy Test	Female participants, who reported positive in urine or serum pregnancy test were reported.	Baseline up to Week 56

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019. Erratum In: J Pain Res. 2020 Sep 14;13:2267-2268.
• 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.
• Schnitzer TJ, Ekman EF, Spierings EL, Greenberg HS, Smith MD, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Ann Rheum Dis. 2015 Jun;74(6):1202-11. doi: 10.1136/annrheumdis-2013-204905. Epub 2014 Mar 13.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2009
• Primary Completion (ACTUAL): October 28, 2010
• Study Completion (ACTUAL): January 12, 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): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: monoclonal antibody; anti-NGF; osteoarthritis (OA); RN624; PF-04383119; tanezumab; nerve growth factor (NGF)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Tanezumab; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: A4091025; 2008-004815-37 (EUDRACT_NUMBER); OA CONTROLLED SAFETY STUDY (OTHER: 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.