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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00809354
Other study ID # A4091025
Secondary ID 2008-004815-37OA
Status Terminated
Phase Phase 3
First received
Last updated
Start date February 12, 2009
Est. completion date January 12, 2011

Study information

Verified date June 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2720
Est. completion date January 12, 2011
Est. primary completion date October 28, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Biological:
tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48)
Drug:
NSAID
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Biological:
tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 48)
Drug:
NSAID
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Locations

Country Name City State
Canada MAC Research Inc. Hamilton Ontario
Canada KW Musculoskeletal Research Inc. Kitchener Ontario
Canada Office of Diane Wilson Lunenburg Nova Scotia
Canada SKDS Research Inc. Newmarket Ontario
Canada The Arthritis Program Research Group Newmarket Ontario
Canada Clinique Medicale St-Louis Quebec
Canada Groupe de Recherche en Rhumatologie et Maladies Osseuses Quebec
Canada Diex Research Sherbrooke Inc. Sherbrooke Quebec
Canada Dr. Saeed Shaikh St. Catharines Ontario
Canada Polyclinique St. Eustache St. Eustache Quebec
Canada Dr. Anil Gupta Toronto Ontario
Canada Centre de Recherche Musculo-Squelettique Trois-Rivieres Quebec
Colombia Centro Integral de Reumatologia e Inmunologia CIREI Bogota Cundinamarca
Colombia Riesgo de Fractura S.A. Bogota-Cundinamarca
Colombia Clinica Las Americas Medellin
Colombia Hospital Pablo Tobon Uribe Medellin Antioquia
Colombia Reumatologya S.A. Medellin
India ChanRe Rheumatology & Immunology Center & Research Bangalore Karnataka
India M.S. Ramaiah Memorial Hospital, Department of Orthopaedics Bangalore Karnataka
India St. Johns Medical College Hospital, Department of Orthopaedics Bangalore Karnataka
India PSG Institute of Medical Sciences and Research Coimbatore Tamilnadu
India CSM Medical University, Department of Rheumatology Lucknow UP
India KMC Hospital, Department of Orthopaedics Mangalore Karnataka
India Sancheti Hospital Pune Maharashtra
India Krishna Institute of Medical Sciences Ltd., Department of Rheumatology Secunderabad Andhra Pradesh
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of Hanyang University Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul St.Mary's Hospital Seoul
Mexico Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C. Coahuila
Mexico Hospital General de Culiacan, S.S., "Dr. Bernardo Gastelum". Culiacan Sinaloa
Mexico URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de Guadalajara"Fray Antonio Alcalde" Guadalajara Jalisco
Mexico Hospital Aranda de la Parra Leon Gto
Mexico Beneficencia Espanola de la Laguna Torreon Coahuila
Netherlands READE Amsterdam
Netherlands UMC St. Radboud Nijmegen
Netherlands UMC Utrecht Utrecht
Philippines Cebu Orthopedic Institute Cebu City
Philippines Chong Hua Hospital, Medical Arts Center Cebu City
Philippines Diaz Building Cebu City
Philippines Davao Doctors Hospital Davao City
Philippines Davao Doctors Hospital, Medical Tower Davao City
Philippines Chinese General Hospital and Medical Center, Out Patient Department Manila
Philippines Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center Manila
Philippines Asian Hospital and Medical Center Muntinlupa
Russian Federation Institution Of Russian Academy of Medical Sciences Moscow
Russian Federation State Healthcare Institution Moscow City Clinical Hospital #4 Moscow
Russian Federation State Healthcare Institution: Moscow City Clinical Hospital #7 Moscow
Russian Federation Saint Petersburg State Medical University named after Pavlov Saint Petersburg
Russian Federation Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov Saint-Petersburg
Russian Federation Saint-Petersburg State Healthcare Institution "City Hospital #26" Saint-Petersburg
South Africa Tiervlei Trial Center Bellville
South Africa Worthwhile Clinical Trials Benoni
South Africa Josha Research Bloemfontein
South Africa Vincent Pallotti Hospital Cape Town
South Africa Private Practice Durban
South Africa Randles Road Medical Center Durban
South Africa A. Briel Durbanville
South Africa Origin Clinical Research Johannesburg
South Africa Clinresco Centres (Pty) Ltd Kempton Park
South Africa Phelang Private Hospital Research Unit Mamelodi East Pretoria
South Africa Paarl Research Center Paarl
South Africa 136 Panorama Medical Center Panorama Cape Town
South Africa TREAD Research Parrowvalley
South Africa Clinical Research Unit Pretoria
Spain Complejo Hospitalario Universitario de A Coruna A Coruna
Spain Hospital de Cruces, Servicio de Reumatologia Barakaldo (Vizcaya)
Spain Clinica CIMA Barcelona
Spain Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA Barcelona
Spain Hospital El Tomillar Dos Hermanas Sevilla
Spain Hospital Universitario La Paz, Servicio de Reumatologia Madrid
Spain Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia Sabadell Barcelona
Spain Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia Santiago De Compostela, A Coruna
Spain Hospital Nuestra Senora de Valme, Servicio de Reumatologia Sevilla
Ukraine Chernivtsi Regional Clinical Hospital Chernivtsi
Ukraine City Clinical Hospital #5 Donetsk
Ukraine V.K. Gusak Institute of Urgent and Recovery Surgery Donetsk
Ukraine Kiev City Clinical Hospital #3 Kiev
Ukraine Kiev City Oleksandrivska Clinical Hospital Kiev
Ukraine State Institution "Institute of Gerontology AMS of Ukraine" Kiev
Ukraine State Institution "Research Centre for Radiation Medicine AMS of Ukraine" Kiev
Ukraine Municipal institution :Zaporizhzhya Regional Clinical Hospital Zaporizhzhya
United States Abilene Arthritis Center Abilene Texas
United States Daystar Clinical Research, Inc. Akron Ohio
United States The Center for Rheumatology, LLP Albany New York
United States Blair Orthopedics Associates Altoona Pennsylvania
United States Advanced Clinical Research Institute Anaheim California
United States Orange County Clinical Trials, Inc. Anaheim California
United States Laureate Clinical Research Group Atlanta Georgia
United States Perimeter Institute for Clinical Reseach, Inc. Atlanta Georgia
United States Dr. Paul K. Pickrell (Physician's Office) Austin Texas
United States Tekton Research, Inc. Austin Texas
United States Arthritis and Rheumatic Disease Specialties Aventura Florida
United States International Physicans Research Aventura Florida
United States Surgery Center of Aventura Aventura Florida
United States American Health Network of Indiana, LLC Avon Indiana
United States Gulf Coast Research, LLC Baton Rouge Louisiana
United States The Bone and Joint Clinic Baton Rouge Louisiana
United States Northwest Clinical Research Center Bellevue Washington
United States Bend Memorial Clinic Bend Oregon
United States Bend Memorial Clinic Bend Oregon
United States The Center for Clinical Trials Biloxi Mississippi
United States Quest Research Institute Bingham Farms Michigan
United States Alliance Clinical Research Birmingham Alabama
United States Radiant Research Birmingham Alabama
United States Rheumatology Associates, P.C. Birmingham Alabama
United States Shades Mountain Imaging Birmingham Alabama
United States HeartCare Bradenton Florida
United States Joao MA Nascimento, MD Bridgeport Connecticut
United States Beacon Clinical Research Brockton Massachusetts
United States SPRI Bronx LLC Bronx New York
United States Arthritis and Osteoporosis Associates of Brooklyn Heights Brooklyn New York
United States Med Center Carmichael California
United States Radiant Research - Phoenix Southeast Chandler Arizona
United States Rehabilitation Institute of Chicago Chicago Illinois
United States eStudySite Chula Vista California
United States Doctor's Urgent Care Offices Cincinnati Ohio
United States New Horizons Clinical Research Cincinnati Ohio
United States Sterling Research Group Cincinnati Ohio
United States Clinical Research of West Florida, Inc. Clearwater Florida
United States The Family Healthcare Center, PA Clinton South Carolina
United States Colorado Springs Family Practice Colorado Springs Colorado
United States Lynn Institute of the Rockies Colorado Springs Colorado
United States Columbia Arthritis Center P.A. Columbia South Carolina
United States Southern Orthopaedic Sports Medicine Columbia South Carolina
United States Columbus Clinical Research, Inc. Columbus Ohio
United States Optimed Research, LTD Columbus Ohio
United States Nature Coast Clinical Research Crystal River Florida
United States Homestead Clinical Research Group, P.A. Cutler Bay Florida
United States Metroplex Clinical Research Center Dallas Texas
United States Dayton Science Institute (DSI) Dayton Ohio
United States Hometown Urgent Care and Research Dayton Ohio
United States PHP - Center for Clinical Research Dayton Ohio
United States STAT Research, Inc. Dayton Ohio
United States Covance CRU, Inc. Daytona Beach Florida
United States Robert W. Levin MD Dunedin Florida
United States Anderson and Collins Clinical Research Inc. Edison New Jersey
United States Central Jersey Medical Research Center Elizabeth New Jersey
United States Center for Arthritis and Osteoporosis Elizabethtown Kentucky
United States Colorado Arthritis Center, PC Englewood Colorado
United States MediSphere Medical Research Center, LLC Evansville Indiana
United States Med Investigations, Inc. Fair Oaks California
United States Internal Medicine Associates Fargo North Dakota
United States Lillestol Research, LLC Fargo North Dakota
United States No. County Internal Medicine & Rheumatology Florissant Missouri
United States Clinical Physiology Associates, Clinical Study Center Fort Myers Florida
United States Internal Medicine Associates Fort Myers Florida
United States Arthritis & Osteoporosis Associates, P.A. Freehold New Jersey
United States Dedicated Clinical Research Goodyear Arizona
United States Eclipse Clinical Research Green Valley Arizona
United States Physicians East P. A. Greenville North Carolina
United States Physicians East, PA Greenville North Carolina
United States Radiant Research Inc Greer South Carolina
United States Mark Fisher, MD, FACRUC Haddon Heights New Jersey
United States Palm Springs Research Institute Hialeah Florida
United States Research Consultants Group Hialeah Florida
United States Clinical Trials of America, Inc Hickory North Carolina
United States Piedmont Rheumatology Hickory North Carolina
United States Peters Medical Research High Point North Carolina
United States East-West Medical Research Institute Honolulu Hawaii
United States Accurate Clinical Research Houston Texas
United States DM Clinical Research Houston Texas
United States Miracle Medical Center Houston Texas
United States One Step Diagnostic Houston Texas
United States Rheumatology Associates of North Alabama, PC Huntsville Alabama
United States Saadat Ansari, MD Office Huntsville Alabama
United States Institute of Arthritis Research Idaho Falls Idaho
United States Arthritis Clinic Jackson Tennessee
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States Rheumatology PC Kalamazoo Michigan
United States Dynamic Clinical Research, Inc. Kansas City Missouri
United States Joan Prouty Moore Kansas City Missouri
United States Orthopaedic & Occupational Medicine Kansas City Missouri
United States Triwest Research La Mesa California
United States Midwest Internal Medicine, PLLC Lake Havasu City Arizona
United States Florida Arthritis Lake Mary Florida
United States Lakewood Orthopedic Medical & Surgical Group Lakewood California
United States Premier Clinical Research LLC. Lakewood California
United States Justus J Fiechtner, MD Lansing Michigan
United States PCM Medical Services Lansing Michigan
United States Rheumatology Consultants of Delaware/Delaware Arthritis Lewes Delaware
United States Pain Treatment Center of the Bluegrass Lexington Kentucky
United States Pasadena Pharmacy Lexington Kentucky
United States Physician Research Collaboration, LLC Lincoln Nebraska
United States Little Rock Diagnostic Clinic, PA Little Rock Arkansas
United States Little Rock Family Practice Clinic Little Rock Arkansas
United States Prohealth Partners Long Beach California
United States Peak Health Medical Group, Inc. Los Angeles California
United States Gill Orthopedic Center Lubbock Texas
United States Robert R. King, M.D. Lubbock Texas
United States Commonwealth Biomedical Research, LLC Madisonville Kentucky
United States Multicare Specialists Madisonville Kentucky
United States David R. Mandel, MD, Inc Mayfield Ohio
United States Ramesh C. Gupta, M.D. Memphis Tennessee
United States Idaho Arthritis & Osteoporosis Center, PC Meridian Idaho
United States Arizona Arthritis & Rheumatology Associates, P.C. Mesa Arizona
United States Pivotal Research Centers Mesa Arizona
United States Southwest Rheumatology, PA Mesquite Texas
United States Community Research Foundation Miami Florida
United States International Research Associates, LLC Miami Florida
United States Pharmax Research Clinic, Inc. Miami Florida
United States Southwest Rheumatology and Research Group, LLC Middleburg Heights Ohio
United States Pivotal Research Centers Midvale Utah
United States Coastal Clinical Research, Inc. Mobile Alabama
United States Office of Vaughn H. Mancha, Jr., MD Montgomery Alabama
United States Saltzer Medical Group PA Nampa Idaho
United States Jeffrey Alper MD Research Naples Florida
United States Synergy Clinical Research Center National City California
United States Hill Country Medical Associates New Braunfels Texas
United States Neurology Clinic of Central Texas New Braunfels Texas
United States NYU Hospital for Joint Diseases New York New York
United States Central Sooner Research Norman Oklahoma
United States Elise Wiesner, MD Norman Oklahoma
United States Integris Family Care of Norman Norman Oklahoma
United States LION Research Norman Oklahoma
United States McBride Clinic Norman Oklahoma
United States McBride Clinic, Inc Norman Oklahoma
United States American Family Medicine Ocala Florida
United States Renstar Medical Research Ocala Florida
United States eStudySite Oceanside California
United States Associated Orthopedics, Inc. Oklahoma City Oklahoma
United States Bone and Joint Hospital at St. Anthony Oklahoma City Oklahoma
United States Christine Codding, MD Oklahoma City Oklahoma
United States Health Research of Oklahoma Oklahoma City Oklahoma
United States Hillcrest Clinical Research Oklahoma City Oklahoma
United States Lynn Health Science Institute Oklahoma City Oklahoma
United States Mc Bride Clinic Oklahoma City Oklahoma
United States McBride Clinic, Inc Oklahoma City Oklahoma
United States Olive Branch Family Medical Center Olive Branch Mississippi
United States Westroads Medical Group Omaha Nebraska
United States Gundersen Clinic Ltd. Onalaska Wisconsin
United States Sunshine Research Center Opa-locka Florida
United States Arthritis Associates Orlando Florida
United States Vince and Associates Clinical Research Overland Park Kansas
United States Vince and Associates Clinical Research Overland Park Kansas
United States MD Medical Research Oxon Hill Maryland
United States Arthritis Research of Florida, Inc. Palm Harbor Florida
United States Desert Medical Group Inc., Desert Oasis Healthcare Palm Springs California
United States Arizona Arthritis & Rheumatology Research, PLLC Paradise Valley Arizona
United States Philip Blum Pasadena Texas
United States New Jersey Physicians, LLC Passaic New Jersey
United States Pearland Primary Care Associates Pearland Texas
United States Southwest Clinical Research Centers, LLC Pearland Texas
United States University Clinical Research Pembroke Pines Florida
United States Pembroke Clinical Trials Pemkbroke Pines Florida
United States Pivotal Research Centers Peoria Arizona
United States Arizona Arthritis & Rheumatology Associates, P.C. Phoenix Arizona
United States Elite Clinical Studies, LLC Phoenix Arizona
United States Highland Community Hospital Picayune Mississippi
United States Mississippi Medical Research Picayune Mississippi
United States Advent Clinical Research Center Inc Pinellas Park Florida
United States Advent Clinical Research Centers Pinellas Park Florida
United States Clinical Trials Research Services, LLC Pittsburgh Pennsylvania
United States Berkshire Rheumatology Pittsfield Massachusetts
United States Prem C. Chatpar, MD, LLC Plainview New York
United States Advanced Family Medical Care Plano Texas
United States Plano Primary Care Clinic Plano Texas
United States Berma Research Group Plantation Florida
United States Accord Clinical Research, LLC Port Orange Florida
United States Doris M. Rice, M.D., F.A.C.R. Portsmouth Virginia
United States Wake Internal Medicine Consultants Inc Raleigh North Carolina
United States Wake Research Associates Raleigh North Carolina
United States Advances in Medicine Rancho Mirage California
United States Regional Health Clinical Research Rapid City South Dakota
United States Regional Medical Clinical-Rheumatology Rapid City South Dakota
United States National Clinical Research Richmond Inc. Richmond Virginia
United States Hypothe Test, LLC Roanoke Virginia
United States The Carolina Center for Rheumatology and Arthritis Care, PA Rock Hill South Carolina
United States Rockford Orthopedic Associates Rockford Illinois
United States ACCR/Internal Medicine Roswell Georgia
United States Mercy Imaging Center Sacramento California
United States Northern Clinical Research Sacramento California
United States A & A Pain Institute Saint Louis Missouri
United States Arthritis Consultants Inc. Saint Louis Missouri
United States Medex Healthcare Research, Inc. Saint Louis Missouri
United States Rheumatology and Internal Medicine Associates of West County, P.C. Saint Louis Missouri
United States Dale G. Bramlet, MD, P.L. Saint Petersburg Florida
United States Crescent Medical Research Salisbury North Carolina
United States Optimum Clinical Research, Inc. Salt Lake City Utah
United States Radiant Research, Inc. Salt Lake City Utah
United States Alamo Clinical Research Associates San Antonio Texas
United States Alamo Clinical Research Consultants San Antonio Texas
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States Innovative Clinical Trials San Antonio Texas
United States Radiant Research San Antonio San Antonio Texas
United States SAM Clinical Research Center San Antonio Texas
United States San Antonio Preventive & Diagnostic Medicine, PA San Antonio Texas
United States South Texas Radiology Imaging Center San Antonio Texas
United States Texas Arthritis Research Center, PA San Antonio Texas
United States The Rehab Group San Antonio Texas
United States California Research Foundation San Diego California
United States San Diego Arthritis Medical Clinic San Diego California
United States Kaiser Permanente Medical Center San Francisco California
United States eStudySite San Jose California
United States Apex Research Institute Santa Ana California
United States Trinity Clinical Trials Santa Ana California
United States HeartCare Research Sarasota Florida
United States Kennedy-White Orthopaedic Center Sarasota Florida
United States Lovelace Scientific Resources Sarasota Florida
United States Sarasota Center for Clinical Research Sarasota Florida
United States The Arthritis Specialty Centre Sarasota Florida
United States Cochise Clinical Research Sierra Vista Arizona
United States Springfield Clinic Springfield Illinois
United States Springfield Clinical Research Department Springfield Illinois
United States St. Joseph Medical Associates Stockton California
United States Sugar Land Med-Ped, PA Sugar Land Texas
United States Tacoma Center for Arthritis Research, PS Tacoma Washington
United States Soutwest Florida Clinical Research Center Tampa Florida
United States Stedman Clinical Trials Tampa Florida
United States Tampa Medical Group, PA Tampa Florida
United States Rheumatology Associates of North Jersey Teaneck New Jersey
United States Premiere Phamaceutical Research, LLC Tempe Arizona
United States Scott & White Healthcare Temple Texas
United States Martin Diagnostic Clinic Tomball Texas
United States Arthritis & Osteoporosis Associates Toms River New Jersey
United States Medical Research Associates Traverse City Michigan
United States Premier Research Trenton New Jersey
United States New England Research Associates, LLC Trumbull Connecticut
United States Arizona Research Associates Tucson Arizona
United States Quality of Life Medical and Research Center Tucson Arizona
United States Radiant Research Tucson Arizona
United States Tucson Orthopaedic Institute Tucson Arizona
United States Rheumatology Associates Inc Tulsa Oklahoma
United States Deerbrook Medical Associates Vernon Hills Illinois
United States Arthritis, Rheumatic & Back Disease Associates Voorhees New Jersey
United States Omega Medical Research Warwick Rhode Island
United States MedVadis Research Corporation Watertown Massachusetts
United States Integrated Clinical Trial Services, Inc West Des Moines Iowa
United States Southgate Medical Group West Seneca New York
United States Westlake Medical Center Westlake Village California
United States Aquilo Clinical Research Yukon Oklahoma
United States Florida Medical Clinic, PA Zephyrhills Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  India,  Korea, Republic of,  Mexico,  Netherlands,  Philippines,  Russian Federation,  South Africa,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Number of Participants Who Had Discontinued Study Due to Lack of Efficacy Baseline up to Week 56
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 Baseline, Week 56
Secondary Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 Baseline, Week 56
Secondary 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
Secondary 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
Secondary 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
Secondary Plasma Trough (Pre-dose) Concentration of Tanezumab Predose on Day 1, Weeks 16, 24, 40, and 56
Secondary 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
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