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

January 6, 2020 updated by: Pfizer

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3021

Phase

Phase 3

Contacts and Locations

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

Study Locations

Australia
- New South Wales
  - Broadmeadow, New South Wales, Australia, 2292
    - Genesis Research Services
  - Cardiff, New South Wales, Australia, 2285
    - Hunter Imaging Group
  - Kogarah, New South Wales, Australia, 2217
    - Optimus Clinical Research Pty Ltd
  - Miranda, New South Wales, Australia, 2228
    - Southern Radiology
  - Randwick, New South Wales, Australia, 2031
    - Royal Hospital for Women
  - St Leonards, New South Wales, Australia, 2065
    - Royal North Shore Hospital
  - St Leonards, New South Wales, Australia, 2065
    - Castlereagh Imaging
  - Sydney, New South Wales, Australia, 2035
    - Australian Clinical Research Network
  - Sydney, New South Wales, Australia, 2035
    - Spectrum Medical Imaging
- Queensland
  - Sherwood, Queensland, Australia, 4075
    - AusTrials Pty Ltd
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - CMAX Clinical Research Pty Ltd
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital Pharmacy
  - North Adelaide, South Australia, Australia, 5006
    - Bensons Radiology
- Victoria
  - Camberwell, Victoria, Australia, 3124
    - Emeritus Research
  - Melbourne, Victoria, Australia, 3144
    - Capital Radiology-Malvern
  - Melbourne, Victoria, Australia, 3168
    - Capital Radiology-Clayton
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - SKG Radiology Hollywood
  - Victoria Park, Western Australia, Australia, 6100
    - RK Will Pty Ltd
Brazil
- Minas Gerais
  - Juiz de Fora, Minas Gerais, Brazil, 36010-570
    - Cmip-Centro Mineiro de Pesquisa Ltda
- RJ
  - Rio De Janeiro, RJ, Brazil, 22271-100
    - CCBR - Centro de Pesquisas e Analises Clinicas LTDA
- SP
  - Sao Paulo, SP, Brazil, 04266-010
    - CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
Bulgaria
- - Plovdiv, Bulgaria, 4000
    - Diagnostic Consultative Center "Sveti Georgi" EOOD
  - Plovdiv, Bulgaria, 4000
    - Medical Center "Health for all" - EOOD
  - Plovdiv, Bulgaria, 4001
    - UMHAT Kaspela - EOOD Rheumatology Clinic
  - Plovdiv, Bulgaria, 4001
    - UMHAT Kaspela - EOOD
  - Ruse, Bulgaria, 7012
    - "Medical Center Teodora" EOOD
  - Sofia, Bulgaria, 1750
    - UMHAT "Sofiamed" OOD, Block 2
  - Sofia, Bulgaria, 1505
    - Diagnostic Consultative Center 17 Sofia EOOD
  - Sofia, Bulgaria, 1612
    - UMHAT Sveti Ivan Rilski- EAD
  - Sofia, Bulgaria, 1784
    - "Medical Center- Dr. Hayvazov" EOOD
Colombia
- Antioquia
  - Medellin, Antioquia, Colombia, 05001000
    - Centro Integral de Reumatologia REUMALAB S.A.S.
- Bogota DC
  - Bogota, Bogota DC, Colombia, 110221
    - Centro de Investigacion en Reumatologia y Especialidades Medicas SAS CIREEM SAS
Croatia
- - Zagreb, Croatia, 10000
    - Medicinski centar Kuna&Peric
Japan
- - Chiba, Japan, 260-8606
    - National Hospital Organization Chiba Medical Center
  - Fukuoka, Japan, 813-8501
    - Chihaya Hospital
  - Fukuoka, Japan, 814-0165
    - Kuroda Orthopedic Hospital
  - Hiroshima, Japan, 730-8619
    - Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
  - Hiroshima, Japan, 734-8530
    - Hiroshima Prefectural Hospital
  - Kumamoto, Japan, 862-0976
    - Kumamoto Orthopaedic Hospital
  - Osaka, Japan, 547-0016
    - Nagayoshi General Hospital
  - Saitama, Japan, 336-8522
    - Saitama Municipal Hospital
  - Saitama, Japan, 330-0056
    - Iwasaki Orthopedic Surgery
- Aichi
  - Toyohashi, Aichi, Japan, 440-8510
    - National Hospital Organization Toyohashi Medical Center
- Chiba
  - Funabashi, Chiba, Japan, 273-8588
    - Funabashi Municipal Medical Center
  - Matsudo, Chiba, Japan, 270-2296
    - Matsudo City General Hospital
- Fukuoka
  - Kitakyushu, Fukuoka, Japan, 806-0026
    - Kanbara Clinic
  - Kurume, Fukuoka, Japan, 830-0053
    - Hidaka Orthopedic Hospital
  - Miyako-gun, Fukuoka, Japan, 800-0344
    - Obase Hospital
  - Yamegun, Fukuoka, Japan, 834-0115
    - Himeno Hospital
- Fukushima
  - Sukagawa, Fukushima, Japan, 962-0001
    - Ikeda Kinen Hospital
- Gunma
  - Maebashi, Gunma, Japan, 379-2115
    - Zenshukai Hospital
- Hiroshima
  - Aki-gun, Hiroshima, Japan, 735-8585
    - Mazda Hospital
  - Kure, Hiroshima, Japan, 734-0304
    - Medical Corporation Okimoto Clinic
  - Kure, Hiroshima, Japan, 737-0046
    - Medical Corporation Emu Emukai, Matterhorn Rehabilitation Hospital
- Hokkaido
  - Chitose, Hokkaido, Japan, 066-0062
    - Takahashi Orthopedics Clinic
  - Obihiro, Hokkaido, Japan, 080-0802
    - Obihiro Orthopaedic Hospital
- Hyogo
  - Akashi, Hyogo, Japan, 674-0051
    - Okubo Hospital
  - Himeji, Hyogo, Japan, 670-0976
    - Omuro Orthopedic Clinic
  - Kako-gun, Hyogo, Japan, 675-1115
    - Medical corporate corporation hoshikai Onishi medical clinic
  - Kobe, Hyogo, Japan, 651-0073
    - Kobe Red Cross Hospital
- Ibaraki
  - Mito, Ibaraki, Japan, 311-4198
    - Mito Saiseikai General Hospital
- Ishikawa
  - Kanazawa, Ishikawa, Japan, 920-8650
    - National Hospital Organization Kanazawa Medical Center
- Kanagawa
  - Kawasaki, Kanagawa, Japan, 210-0852
    - Kokan Clinic
- Kyoto
  - Yawata, Kyoto, Japan, 614-8366
    - Misugikai Medical Corporation Otokoyama Hospital
- Miyagi
  - Sendai, Miyagi, Japan, 983-0862
    - Nakajo Orthopedic Clinic
- Nagano
  - Matsumoto, Nagano, Japan, 390-8601
    - Marunouchi Hospital
- Oita
  - Yufu, Oita, Japan, 879-5593
    - Oita University Hospital
- Osaka
  - Higashiosaka, Osaka, Japan, 577-0011
    - Sobajima Clinic/Orthopedics
  - Izumisano, Osaka, Japan, 598-8577
    - Rinku General Medical Center
  - Kishiwada, Osaka, Japan, 596-8522
    - Kishiwada Tokushukai Hospital
  - Osaka-shi, Osaka, Japan, 530-0012
    - Social Welfare Organization Saiseikai Imperial Gift Foundation,Inc. Osaka Saiseikai Nakatsu Hospital
  - Suita, Osaka, Japan, 565-0871
    - Osaka University Hospital
- Shimane
  - Izumo, Shimane, Japan, 693-8501
    - Shimane University Hospital
- Shizuoka
  - Fujieda, Shizuoka, Japan, 426-8677
    - Fujieda Municipal General Hospital
  - Hamamatsu, Shizuoka, Japan, 430-0929
    - JA Shizuoka Kohseiren Enshu Hospital
  - Hamamatsu, Shizuoka, Japan, 434-8533
    - Japanese Red Cross Hamamatsu Hospital
- Tokyo
  - Adachi-ku, Tokyo, Japan, 121-0064
    - Sonodakai Joint Replacement Center Hospital
  - Edogawa-ku, Tokyo, Japan, 133-0052
    - Medical Plaza Edogawa
  - Edogawa-ku, Tokyo, Japan, 134-0084
    - Sato Orthopaedic Clinic
  - Fussa, Tokyo, Japan, 197-8511
    - Fussa Hospital
  - Koto-ku, Tokyo, Japan, 136-0073
    - Jukoukai hospital
  - Minato-ku, Tokyo, Japan, 108-8642
    - Kitasato University Kitasato Institute Hospital
  - Setagaya-ku, Tokyo, Japan, 158-0095
    - Tamagawa Hospital
  - Shinagawa-ku, Tokyo, Japan, 140-0014
    - Ohimachi Orthopaedic Clinic
  - Shinagawa-ku, Tokyo, Japan, 140-0001
    - Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital
- Tottori
  - Yonago, Tottori, Japan, 683-8605
    - Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
Korea, Republic of
- - Daegu, Korea, Republic of, 42472
    - Daegu Catholic University Medical Center
  - Daegu, Korea, Republic of, 42472
    - Department of Radiology
  - Daegu, Korea, Republic of, 42472
    - Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University Medical Center
  - Daejeon, Korea, Republic of, 35015
    - Chungnam National University Hospital
  - Daejeon, Korea, Republic of, 35015
    - Clinical Trial Center Pharmacy
  - Daejeon, Korea, Republic of, 35015
    - Department of Radiology
  - Gwangju, Korea, Republic of, 61469
    - Chonnam National University Hospital
  - Gwangju, Korea, Republic of, 61469
    - Department of Radiology
  - Gwangju, Korea, Republic of, 61469
    - Pharmacy of Clinical Trial Center
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05030
    - Konkuk University Medical Center
  - Seoul, Korea, Republic of, 02841
    - Korea University Anam Hospital
  - Seoul, Korea, Republic of, 07985
    - Ewha Womans University Mokdong Hospital
  - Seoul, Korea, Republic of, 06591
    - The Catholic University of Korea Seoul St. Mary'S Hospital
  - Seoul, Korea, Republic of, 07061
    - SMG-SNU Boramae Medical Center
  - Seoul, Korea, Republic of, 03722
    - Yonsei University Health System, Severance Hospital
  - Seoul, Korea, Republic of, 02841
    - Clinical trial Pharmacy
  - Seoul, Korea, Republic of, 02841
    - Department of Radiology
  - Seoul, Korea, Republic of, 03080
    - Clinical Trials Center Pharmacy
  - Seoul, Korea, Republic of, 03722
    - Clinical Trial Center Pharmacy
  - Seoul, Korea, Republic of, 03722
    - Department of Radiology
  - Seoul, Korea, Republic of, 05030
    - Clinical research pharmacy
  - Seoul, Korea, Republic of, 05030
    - Department of Clinical Research Pharmacy, Konkuk University Medical Center
  - Seoul, Korea, Republic of, 05030
    - Department of Radiology
  - Seoul, Korea, Republic of, 05030
    - Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center
  - Seoul, Korea, Republic of, 06351
    - Clinical Trial Center Pharmacy
  - Seoul, Korea, Republic of, 06351
    - Department of Orthopedic Surgery, Samsung Medical Center
  - Seoul, Korea, Republic of, 06591
    - Clinical trial Pharmacy
  - Seoul, Korea, Republic of, 06591
    - Department of Radiology
  - Seoul, Korea, Republic of, 07061
    - Clinical Research Pharmacy, SMG SNU Boramae Medical Center
  - Seoul, Korea, Republic of, 07061
    - Department of Clinical Research Pharmacy, SMG-SNU Boramae Medical Center
  - Seoul, Korea, Republic of, 07061
    - Department of Radiology
  - Seoul, Korea, Republic of, 07985
    - Department of Radiology
  - Yangcheon-gu, Seoul, Korea, Republic of, 07985
    - Clinical trial Pharmacy
Lithuania
- - Kaunas, Lithuania, LT-49449
    - Saules Seimos Medicinos Centras
  - Klaipeda, Lithuania, LT-92288
    - Klaipeda university hospital
  - Siauliai, Lithuania, LT-76231
    - Republican Siauliai Hospital
Mexico
- Jalisco
  - Guadajara, Jalisco, Mexico, 45050
    - Centro Hospitalario Mac, S.A. de C.V.
  - Guadalajara, Jalisco, Mexico, 45040
    - Consultorio Médico del Dr. Federico Galván Villegas
New Zealand
- - Auckland, New Zealand, 1010
    - Optimal Clinical Trials
  - Auckland, New Zealand, 0610
    - South Pacific Clinical Trials
  - Auckland, New Zealand, 0610
    - TRG Imaging Lincoln Road
  - Auckland, New Zealand, 0612
    - Auckland Bone Density Ltd
  - Auckland, New Zealand, 0622
    - North Shore Hospital, Waitemata District Health Board
  - Auckland, New Zealand, 0622
    - Star Unit, North Shore Hospital, Waitemata District Health Board
  - Auckland, New Zealand, 0622
    - The Radiology Group
  - Auckland, New Zealand, 0626
    - Southern Clinical Trials- Waitemata Ltd
  - Auckland, New Zealand, 0632
    - Auckland Bone Density
  - Auckland, New Zealand, 1052
    - Auckland Radiology Parnell Branch
  - Christchurch, New Zealand, 8013
    - Southern Clinical Trials Ltd
  - Nelson, New Zealand, 7010
    - Collingwood Street Pharmacy
  - Nelson, New Zealand, 7010
    - Nelson Radiology
  - Nelson, New Zealand, 7010
    - Porter Rheumatology Ltd
  - Tauranga, New Zealand, 3112
    - Clinical Horizons NZ Ltd
  - Tauranga, New Zealand, 3110
    - Bay Radiology
  - Tauranga, New Zealand, 3110
    - P3 Research Ltd
  - Wellington, New Zealand, 6021
    - P3 Research Ltd
  - Wellington, New Zealand, 6021
    - Pacific Radiology
- BOP
  - Rotorua, BOP, New Zealand, 3010
    - Lakeland Clinical Trials
- Otago
  - Dunedin, Otago, New Zealand, 9010
    - Otago Radiology
  - Dunedin, Otago, New Zealand, 9012
    - RMC Medical Research Ltd
Peru
- - Lima, Peru, 21
    - ABK REUMA S.R.L. de Medicentro Biociencias/BIO CIENCIAS PERU S.R.L.
  - Lima, Peru, 27
    - Centro de Investigación Reumatología CAA-Clinica Anglo Americana
  - Lima, Peru, 27
    - Investigaciones en Reumatologia / Centro Medico Corpac S.A.
  - Lima, Peru, 29
    - Centro de Investigaciones Medicas-Hospital Maria Auxiliadora
  - Lima, Peru, 33
    - Investigaciones Clinicas S.A.C. / Instituto de Ginecologia y Reproduccion S.A.
  - Lima, Peru, 33
    - Investigaciones Clinicas S.A.C./Instituto de Ginecologia y Reproduccion S.A.
- Arequipa
  - Cayma, Arequipa, Peru
    - Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios
- LA Libertad
  - Trujillo, LA Libertad, Peru, 13001
    - Centro De Investigacion Clinica Trujillo EIRL/Clinica Peruano Americana S.A.
Philippines
- - Manila, Philippines, 1000
    - Manila Doctors Hospital
- NCR
  - Manila, NCR, Philippines, 1000
    - Philippine General Hospital
Russian Federation
- - Moscow, Russian Federation, 119049
    - Moscow Municipal Rheumatology Center
  - Moscow, Russian Federation, 119049
    - SBHI "City Clinical Hospital No. 1 n.a N.I. Pirogov"
  - Moscow, Russian Federation, 119049
    - SBHI "City Clinical Hospital No. 1 n.a. N.I. Pirogov"
  - Novosibirsk, Russian Federation, 630117
    - Federal State Budgetary Scientific Institution
  - Novosibirsk, Russian Federation, 630047
    - Federal State Budgetary Scientific Research institution of fundamental and clinical immunology
  - Ryazan, Russian Federation, 390026
    - State Budgetary Institution of Ryazan Region
  - Saint Petersburg, Russian Federation, 191025
    - Medical Technologies Ltd
  - Saint Petersburg, Russian Federation, 194354
    - Limited Liability Company "Medical Center "Reavita Med SPb"
  - Saint Petersburg, Russian Federation, 194356
    - Medinet LLC
  - Saint Petersburg, Russian Federation, 195427
    - FSBI 'SRITO n.a. R.R. Vreden' MoH RF
Serbia
- - Belgrade, Serbia, 11000
    - Institute of Rheumatology
  - Belgrade, Serbia, 11000
    - Institute for Rehabilitation
  - Niska Banja, Serbia, 18205
    - Institute For Treatment and Rehabilitation "Niska Banja"
  - Novi Sad, Serbia, 21000
    - Special Hospital For Rheumatic Diseases Novi Sad
  - Sabac, Serbia, 15000
    - General Hospital "Dr Laza K. Lazarevic" Sabac
Slovakia
- - Bratislava, Slovakia, 820 07
    - Reumatologia s.r.o.
  - Bratislava, Slovakia, 841 04
    - Nestatna Reumatologicka Ambulancia, Poliklinika Karlova Ves
  - Kosice, Slovakia, 040 11
    - MUDr. STRANAI s.r.o.
  - Nove Mesto nad Vahom, Slovakia, 91501
    - Reum.hapi s.r.o.
  - Piestany, Slovakia, 921 01
    - MEDIPA s.r.o.
  - Piestany, Slovakia, 92101
    - Thermium s.r.o.
Taiwan
- - Changhua, Taiwan, 500
    - Changhua Christian Hospital
  - Changhua, Taiwan, 500
    - Changhua Christian Hospital Clinical Trial Pharmacy
  - Kaohsiung, Taiwan, 83301
    - Chang Gung Memorial Hospital-Kaohsiung Branch Clinical Trial Pharmacy
  - Kaohsiung, Taiwan, 83301
    - Chang Gung Memorial Hospital-Kaohsiung Branch
  - Taichung, Taiwan, 40447
    - China Medical University Hospital
  - Taichung, Taiwan, 402
    - Chung Shan Medical University Hospital
  - Taichung, Taiwan, 402
    - Chung Shan Medical University Hospital Clinical Trial Pharmacy
  - Taichung, Taiwan, 40447
    - Department of Pharmacy, China Medical University Hospital
Ukraine
- - Chernivtsi, Ukraine, 58001
    - Regional Communal Institution Chernivtsi Regional Clinical Hospital
  - Kharkiv, Ukraine, 61002
    - Communal Non-profit Institution "City Clinical Hospital No.27" of Kharkiv City Council
  - Kharkiv, Ukraine, 61039
    - Government Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"
  - Kyiv, Ukraine, 01601
    - Chair of Internal Medicine #2
  - Kyiv, Ukraine, 01601
    - Oleksandrivska Clinical Hospital of Kyiv
  - Kyiv, Ukraine, 02125
    - Kyiv City Clinical Hospital 3,Rheumatology Department
  - Kyiv, Ukraine, 03151
    - Clinic of NI "NSC"M.D.Strazhesko Institute of Cardiology" of NAMS of Ukraine,
  - Kyiv, Ukraine, 04050
    - Polyclinic of Administration of Medical Services and Rehabilitation of State Stock Holding Company
  - Kyiv, Ukraine, 04114
    - Clinic of SI "Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine"
  - Kyiv, Ukraine, 04114
    - Clinic of SI Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine
  - Kyiv, Ukraine, 04119
    - National Medical University named after O O Bogomolets,
  - Kyiv, Ukraine, 04119
    - Polyclinic Of Administration of Medical Services and Rehabilitation of SSHC Artem
  - Lviv, Ukraine, 79013
    - Communal Non-profit Institution "City Clinical Hospital #5 of Lviv", Therapeutics Department
  - Odesa, Ukraine, 65025
    - Communal Institution "Odesa Regional Clinical Hospital"
  - Odesa, Ukraine, 65026
    - Multi-field Medical Center (University Clinic No.1) of Odesa National Medical University,
  - Ternopil, Ukraine, 46002
    - Communal Institution Ternopil University Hospital
  - Vinnytsia, Ukraine, 21018
    - Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov, Rheumatology Department,
  - Vinnytsia, Ukraine, 21029
    - Communal Non-commercial Enterprise "Vinnytsia City Clinical Hospital No 1"
  - Vinnytsia, Ukraine, 21029
    - Medical Clinical Investigational Centre of Medical Centre Health Clinic LTD
  - Vinnytsia, Ukraine, 21029
    - Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Medical
  - Vinnytsia, Ukraine, 21029
    - Vinnytsya Medical National University named after M.I. Pyrogov, Chair of Internal Medicine #3
  - Zaporizhzhya, Ukraine, 69600
    - Communal Institution Zaporizhzhya Regional Clinical Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35235
    - Alabama Clinical Therapeutics, LLC
  - Birmingham, Alabama, United States, 35216
    - Achieve Clinical Research, LLC
  - Birmingham, Alabama, United States, 35209
    - Central Alabama Research
  - Birmingham, Alabama, United States, 35235
    - Alabama Orthopaedic Surgeons
  - Huntsville, Alabama, United States, 35801
    - Rheumatology Associates of North Alabama, PC
  - Mobile, Alabama, United States, 36608
    - Coastal Clinical Research, Inc.
- Arizona
  - Mesa, Arizona, United States, 85215
    - Ferguson Family Medicine
  - Phoenix, Arizona, United States, 85053
    - Arizona Research Center
  - Phoenix, Arizona, United States, 85032
    - Arizona Arthritis & Rheumatology Associates, P.C.
  - Scottsdale, Arizona, United States, 85254
    - Valley Pain Consultants
  - Tempe, Arizona, United States, 85283
    - Clinical Research Consortium
  - Tucson, Arizona, United States, 85704
    - Noble Clinical Research, LLC
  - Tucson, Arizona, United States, 85712
    - Quality of Life Medical & Research Centers, LLC
  - Tucson, Arizona, United States, 85712
    - Tucson Orthopaedic Institute - Research Center
- Arkansas
  - Hot Springs, Arkansas, United States, 71913
    - CHI St. Vincent Medical Group Hot Springs
  - Little Rock, Arkansas, United States, 72205
    - Lynn Institute of the Ozarks
  - Little Rock, Arkansas, United States, 72205
    - Chrystal Johnson
  - Little Rock, Arkansas, United States, 72205
    - KLR Business Group, Inc., dba Arkansas Clinical Research
  - Little Rock, Arkansas, United States, 72205
    - Larry Watkins, MD
- California
  - Anaheim, California, United States, 92805
    - Advanced Research Center
  - Anaheim, California, United States, 92801
    - Orange County Research Institute
  - Bellflower, California, United States, 90706
    - CiTrials
  - Beverly Hills, California, United States, 90211
    - Osteoporosis Medical Center
  - Canoga Park, California, United States, 91303
    - HOPE Clinical Research
  - Carmichael, California, United States, 95608
    - Med Center
  - Cerritos, California, United States, 90703
    - Core Healthcare Group
  - Covina, California, United States, 91723
    - Pleitez Medical Clinic
  - El Cajon, California, United States, 92020
    - TriWest Research Associates, LLC
  - Encino, California, United States, 91436
    - T. Joseph Raoof MD, INC/Encino Research Center
  - Escondido, California, United States, 92029
    - San Diego Imaging Escondido
  - Fair Oaks, California, United States, 95628
    - Med Investigations, Inc.
  - Fresno, California, United States, 93710
    - Neuro-Pain Medical Center
  - Fresno, California, United States, 93702
    - Research Center of Fresno, Inc.
  - Garden Grove, California, United States, 92845
    - Collaborative Neuroscience Network, LLC.
  - Gold River, California, United States, 95670
    - Allied Clinical Research
  - Huntington Beach, California, United States, 92647
    - Marvel Clinical Research LLC
  - Huntington Beach, California, United States, 92646
    - HealthCare Partners Clinical Research, LLC.
  - La Mesa, California, United States, 91941
    - BioSolutions Clinical Research Center
  - La Mesa, California, United States, 91942
    - eStudySite
  - La Palma, California, United States, 90723
    - Arthritis & Osteoporosis Medical Center
  - Lakewood, California, United States, 90805
    - Center For United Research, Inc.
  - Long Beach, California, United States, 90806
    - Collaborative Neuroscience Network, LLC.
  - Los Angeles, California, United States, 90017
    - American Institute of Research
  - Los Angeles, California, United States, 90020
    - IMD Medical Group
  - Los Angeles, California, United States, 90010
    - Aeon Research, Inc.
  - Los Angeles, California, United States, 90017
    - InterMed Medical Group
  - Montclair, California, United States, 91763
    - Catalina Research Institute, LLC
  - North Hollywood, California, United States, 91606
    - Providence Clinical Research
  - Northridge, California, United States, 91328
    - Renaissance Imaging Medical Associates, Inc
  - Orange, California, United States, 92868
    - NRC Research Institute
  - Palm Desert, California, United States, 92260
    - Advances in Medicine
  - Riverside, California, United States, 92501
    - Probe Clinical Research Corporation
  - Sacramento, California, United States, 95821
    - Northern California Research
  - Sacramento, California, United States, 95821
    - Clinical Trials Research
  - Sacramento, California, United States, 95817
    - University of California, Davis Medical Center
  - Sacramento, California, United States, 95823
    - Center for Clinical Trials of Sacramento, Inc.
  - Sacramento, California, United States, 95817
    - University of California, Davis Health System
  - San Diego, California, United States, 92103
    - Artemis Institute for Clinical Research
  - San Diego, California, United States, 92123
    - San Diego Imaging, Kearny Mesa
  - San Diego, California, United States, 92123
    - Sharp and Children's MRI Center, LLC
  - San Marcos, California, United States, 92078
    - Artemis Institute for Clinical Research
  - Santa Ana, California, United States, 92705
    - Syrentis Clinical Research
  - Santa Ana, California, United States, 92705
    - CiTrials
  - Thousand Oaks, California, United States, 91360
    - Westlake Medical Research
  - Thousand Oaks, California, United States, 91360
    - Shariar Cohen, MD Corp.
  - Valley Village, California, United States, 91607
    - Bayview Research Group
  - Van Nuys, California, United States, 91405
    - Renaissance Imaging Medical Associates, Inc
  - West Covina, California, United States, 91790
    - Buhay & Maglunog MDS
  - West Hills, California, United States, 91303
    - Prohealth Advanced Imaging
  - Westminster, California, United States, 92683
    - Advanced Rx Clinical Research Group, Inc
  - Whittier, California, United States, 90602
    - Medvin Clinical Research
  - Wildomar, California, United States, 92595
    - Elite Clinical Trials
- Colorado
  - Denver, Colorado, United States, 80209
    - Mountain View Clinical Research, Inc.
  - Denver, Colorado, United States, 80209
    - Mountain View Clinical Research, Inc
- Connecticut
  - Bridgeport, Connecticut, United States, 06606
    - New England Research Associates, LLC
  - Danbury, Connecticut, United States, 06810
    - Clinical Research Center of Ct
  - Stamford, Connecticut, United States, 06905
    - Stamford Therapeutics Consortium
- Delaware
  - Lewes, Delaware, United States, 19958
    - Delaware Arthritis
  - Newark, Delaware, United States, 19713
    - Javed Rheumatology Associates, Inc.
- Florida
  - Atlantis, Florida, United States, 33462
    - JEM Research Institute
  - Aventura, Florida, United States, 33180
    - AARDS Research, Inc.
  - Boca Raton, Florida, United States, 33486
    - RASF-Clinical Research, Inc
  - Boynton Beach, Florida, United States, 33472
    - Orthopedic Research Institute
  - Brooksville, Florida, United States, 34601
    - Meridien Research
  - Clearwater, Florida, United States, 33761
    - Tampa Bay Medical Research, Inc
  - Clearwater, Florida, United States, 33756
    - Orthopaedic Associates of West Florida
  - DeLand, Florida, United States, 32720
    - Midland Florida Clinical Research Center, LLC
  - Fort Lauderdale, Florida, United States, 33309
    - Centre for Rheumatology, Immunology and Arthritis
  - Fort Lauderdale, Florida, United States, 33306
    - S&W Clinical Research
  - Fort Myers, Florida, United States, 33912
    - Clinical Physiology Associates
  - Fort Myers, Florida, United States, 33912
    - IMA
  - Gainesville, Florida, United States, 32607
    - SIMEDHealth, LLC
  - Hialeah, Florida, United States, 33016
    - South Florida Clinical Trials
  - Hollywood, Florida, United States, 33024
    - Pines Clinical Research Inc.
  - Jacksonville, Florida, United States, 32216
    - Jacksonville Center for Clinical Research
  - Jacksonville, Florida, United States, 32256
    - Clinical Neuroscience Solutions, Inc.
  - Jacksonville, Florida, United States, 32218
    - Care Partners Clinical Research
  - Miami, Florida, United States, 33183
    - International Research Associates, LLC
  - Miami, Florida, United States, 33175
    - New Horizon Research Center
  - Miami, Florida, United States, 33126
    - Pharmax Research Clinic, Inc.
  - Miami, Florida, United States, 33125
    - Columbus Clinical Services LLC
  - Miami, Florida, United States, 33185
    - M&M Medical Center, Inc.
  - Miami, Florida, United States, 33173
    - Center for Arthritis and Rheumatic Diseases
  - Miami, Florida, United States, 33135
    - Clintex Research Group
  - Miami, Florida, United States, 33186
    - Quality Research & Medical Center LLC
  - Miami, Florida, United States, 33173
    - Larkin Imaging Center
  - Ocala, Florida, United States, 34470
    - Renstar Medical Research
  - Ocala, Florida, United States, 34471
    - American Family Medical
  - Ocoee, Florida, United States, 34761
    - Sensible Healthcare, LLC.
  - Oldsmar, Florida, United States, 34677
    - Journey Research, Inc.
  - Opa-locka, Florida, United States, 33054
    - Sunshine Research Center
  - Orlando, Florida, United States, 32806
    - Compass Research, LLC
  - Orlando, Florida, United States, 32810
    - Omega Research Consultants, LLC
  - Orlando, Florida, United States, 32806
    - Rheumatology Associates of Central Florida, P.A.
  - Oviedo, Florida, United States, 32765
    - Oviedo Medical Research, LLC
  - Pensacola, Florida, United States, 32503
    - Pensacola Research Consultants, Inc., d.b.a. Avanza Medical Research Center
  - Pensacola, Florida, United States, 32503
    - Sacred Heart Orthopedics
  - Plantation, Florida, United States, 33324
    - Orthopaedic Center of South Florida
  - Ponte Vedra, Florida, United States, 32081
    - St. Johns Center for Clinical Research
  - Port Orange, Florida, United States, 32129
    - Accord Clinical Research, LLC
  - Port Orange, Florida, United States, 32127
    - Progressive Medical Research
  - Saint Petersburg, Florida, United States, 33709
    - Meridien Research
  - Sarasota, Florida, United States, 34232
    - Gulfcoast Research Institute, Llc
  - Sarasota, Florida, United States, 34232
    - Kennedy White Orthopaedic Center
  - Sunrise, Florida, United States, 33351
    - Precision Clinical Research, LLC.
  - Tamarac, Florida, United States, 33321
    - Phoenix Clinical Research, LLC.
  - Tampa, Florida, United States, 33613
    - Stedman Clinical Trials
  - Tampa, Florida, United States, 33603
    - Clinical Research of West Florida, Inc.
  - Tampa, Florida, United States, 33614
    - BayCare Medical Group, Inc
  - The Villages, Florida, United States, 32162
    - Compass Research North LLC
  - West Palm Beach, Florida, United States, 33409
    - Palm Beach Research Center
- Georgia
  - Atlanta, Georgia, United States, 30331
    - Atlanta Center for Medical Research
  - Atlanta, Georgia, United States, 30338
    - Perimeter Institute for Clinical Research, Inc. DBA:/PICR Clinic
  - Augusta, Georgia, United States, 30909
    - Masters of Clinical Research, Inc.
  - Blue Ridge, Georgia, United States, 30513
    - River Birch Research Alliance, LLC
  - Gainesville, Georgia, United States, 30501
    - Arthritis Center of North Georgia
  - Gainesville, Georgia, United States, 30501
    - Center for Advanced Research & Education
  - Marietta, Georgia, United States, 30060
    - Drug Studies America
  - Newnan, Georgia, United States, 30265
    - Better Health Clinical Research, Inc.
  - Stockbridge, Georgia, United States, 30281
    - Atlanta Orthopaedic Institute, LLC
  - Suwanee, Georgia, United States, 30024
    - Herman Clinical Research, LLC
  - Woodstock, Georgia, United States, 30189
    - North Georgia Clinical Research
  - Woodstock, Georgia, United States, 30189
    - North Georgia Internal Medicine
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - East-West Medical Research Institute
- Idaho
  - Boise, Idaho, United States, 83713
    - Injury Care Research, LLC
  - Boise, Idaho, United States, 83706
    - Idaho Sports Medicine Institute
  - Idaho Falls, Idaho, United States, 83404
    - Institute of Arthritis Research
  - Meridian, Idaho, United States, 83642
    - Advanced Clinical Research
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60611
    - Northwestern University Feinberg School of Medicine
  - Chicago, Illinois, United States, 60640
    - Great Lakes Clinical Trials
  - Chicago, Illinois, United States, 60602
    - Medex Healthcare Research, Inc.
  - Chicago, Illinois, United States, 60607
    - Chicago Clinical Research Institute Inc.
  - Chicago, Illinois, United States, 60611
    - Northwestern Memorial Hospital-Arkes Pavilion, Diagnostic Testing Center
  - Oak Lawn, Illinois, United States, 60453
    - Affinity Clinical Research Institute
  - Oak Lawn, Illinois, United States, 60453
    - Southwest Center for Healthy Joints, S.C.
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61602
    - Methodist Research Administration Office
  - Peoria, Illinois, United States, 61602
    - UnityPoint Clinic Rheumatology
  - Rockford, Illinois, United States, 61114
    - OrthoIllinois
  - Rockford, Illinois, United States, 61114
    - Quest Diagnostics
- Indiana
  - Evansville, Indiana, United States, 47714
    - MediSphere Medical Research Center, LLC
  - Valparaiso, Indiana, United States, 46383
    - Buynak Clinical Research, P.C.
- Kansas
  - Overland Park, Kansas, United States, 66210
    - Mid-America Physiatrists, P.A.
  - Prairie Village, Kansas, United States, 66208
    - Phoenix Medical Research, Inc.
  - Wichita, Kansas, United States, 67207
    - Heartland Research Associates, LLC
  - Wichita, Kansas, United States, 67205-1138
    - Professional Research Network of Kansas, LLC
- Kentucky
  - Edgewood, Kentucky, United States, 41017
    - Otrimed Corporation
  - Lexington, Kentucky, United States, 40509
    - Central Kentucky Research Associates, Inc.
- Louisiana
  - Baton Rouge, Louisiana, United States, 70806
    - Baton Rouge General Medical Center-Internal Medicine Clinic
  - Baton Rouge, Louisiana, United States, 70806
    - Baton Rouge General Medical Center-Midcity
  - Baton Rouge, Louisiana, United States, 70809
    - Baton Rouge General Medical Center-Bluebonnet
  - Baton Rouge, Louisiana, United States, 70809
    - Baton Rouge General Medical Center-Clinical Trials Office
  - Lake Charles, Louisiana, United States, 70601
    - Centex Studies, Inc.
- Maryland
  - Cumberland, Maryland, United States, 21502
    - Klein & Associates, M.D., P.A.
  - Frederick, Maryland, United States, 21702
    - Arthritis Treatment Center
  - Hagerstown, Maryland, United States, 21740
    - Klein & Associates, M.D., P.A.
  - Wheaton, Maryland, United States, 20902
    - The Center for Rheumatology and Bone Research
- Massachusetts
  - Quincy, Massachusetts, United States, 02169
    - Beacon Clinical Research, LLC
  - Watertown, Massachusetts, United States, 02472
    - MedVadis Research Corporation
- Michigan
  - Bay City, Michigan, United States, 48706
    - Great Lakes Research Group, Incorporated
  - Caro, Michigan, United States, 48723
    - Onyx Clinical Research
  - Grand Rapids, Michigan, United States, 49525
    - Orthopaedic Associates of Michigan, PC
  - Lansing, Michigan, United States, 48910
    - June D.O. PC
  - Pinconning, Michigan, United States, 48650
    - Great Lakes Research Group
  - Rochester Hills, Michigan, United States, 48307
    - Michigan Orthopaedic Spine Surgeons
  - Traverse City, Michigan, United States, 49686
    - Medical Research Associates Inc.
  - Troy, Michigan, United States, 48085
    - Oakland Medical Research Center
- Mississippi
  - Olive Branch, Mississippi, United States, 38654
    - Olive Branch Family Medical Center
  - Southaven, Mississippi, United States, 38671
    - Landmark Internal Medicine
- Missouri
  - Columbia, Missouri, United States, 65212
    - University of Missouri Health Care
  - Columbia, Missouri, United States, 65212
    - University of Missouri Health Care-Investigational Pharmacy
  - Columbia, Missouri, United States, 65212
    - University of Missouri School of Medicine- Clinical Research Center
  - Saint Louis, Missouri, United States, 63117
    - Medex Healthcare Research, Inc.
  - Saint Louis, Missouri, United States, 63109
    - Advance Clinical Research, Inc.
- Nebraska
  - Lincoln, Nebraska, United States, 68516
    - Physician Research Collaboration, LLC
- Nevada
  - Las Vegas, Nevada, United States, 89119
    - Clinical Research Consortium
  - Las Vegas, Nevada, United States, 89123
    - Advanced Biomedical Research of America
  - Las Vegas, Nevada, United States, 89106
    - Impact Clinical Trials
  - Las Vegas, Nevada, United States, 89128
    - G. Timothy Kelly, MD
  - Las Vegas, Nevada, United States, 89119
    - Office of Robert P. Kaplan, DO
  - Las Vegas, Nevada, United States, 89106
    - Affiliated Clinical Research, Inc.
  - Las Vegas, Nevada, United States, 89117
    - Office of Stephen H. Miller, MD
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - ActivMed Practices & Research, Inc.
- New Jersey
  - Toms River, New Jersey, United States, 08755
    - Ocean Rheumatology, PA
  - Trenton, New Jersey, United States, 08611
    - Premier Research
  - Voorhees, New Jersey, United States, 08043
    - Arthritis, Rheumatic and Back Disease Associates, PA
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Albuquerque Clinical Trials, Inc.
  - Albuquerque, New Mexico, United States, 87106
    - New Mexico Clinical Research & Osteoporosis Center, Inc.
  - Albuquerque, New Mexico, United States, 87108
    - Lovelace Scientific Resources Inc.
- New York
  - Brooklyn, New York, United States, 11235
    - SPRI Clinical Trials, LLC
  - Brooklyn, New York, United States, 11201
    - NYU Langone Ambulatory Care Brooklyn Heights
  - Brooklyn, New York, United States, 11230
    - Drug Trials Brooklyn
  - Hartsdale, New York, United States, 10530
    - Drug Trials America
  - Lake Success, New York, United States, 11042
    - NYU Langone Rheumatology Associates Long Island
  - Lake Success, New York, United States, 11042
    - NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center, Infusion Center
  - Lake Success, New York, United States, 11042
    - NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center
  - New York, New York, United States, 10128
    - The Medical Research Network, LLC
  - New York, New York, United States, 10016
    - Manhattan Medical Research Practice PLLC
  - New York, New York, United States, 10016
    - Lenox Hill Radiology
  - Rochester, New York, United States, 14618
    - AAIR Research Center
  - Williamsville, New York, United States, 14221
    - Upstate Clinical Research Associates, LLC
- North Carolina
  - Lenoir, North Carolina, United States, 28645
    - Northstate Clinical Research, PLLC
  - Raleigh, North Carolina, United States, 27612
    - Wake Research Associates, LLC
  - Raleigh, North Carolina, United States, 27612
    - Wake Internal Medicine Consultants, Inc
  - Winston-Salem, North Carolina, United States, 27103
    - The Center for Clinical Research
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Plains Clinical Research Center, LLC
  - Fargo, North Dakota, United States, 58103
    - Lillestol Research, LLC
- Ohio
  - Centerville, Ohio, United States, 45459
    - Valley Medical Research/Valley Medical Primary Care
  - Cincinnati, Ohio, United States, 45242
    - New Horizons Clinical Research
  - Cincinnati, Ohio, United States, 45224
    - Hightop Medical Research Center
  - Cincinnati, Ohio, United States, 45255
    - CTI Clinical Research Center
  - Columbus, Ohio, United States, 43235
    - Optimed Research Ltd
  - Columbus, Ohio, United States, 43215
    - Remington-Davis, Incorporated
  - Columbus, Ohio, United States, 43213
    - Aventiv Research Inc.
  - Dayton, Ohio, United States, 45406
    - Dayton Clinical Research
  - Dayton, Ohio, United States, 45419
    - PriMED Clinical Research
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Springboro, Ohio, United States, 45066
    - Springboro Health Center
  - Tiffin, Ohio, United States, 44883
    - AC Clinical Research
  - Toledo, Ohio, United States, 43614
    - Glendale Medical Center
  - Toledo, Ohio, United States, 43623
    - Bone Joint & Spine Surgeons, Inc.
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Lynn Health Science Institute
  - Oklahoma City, Oklahoma, United States, 73103
    - Health Research of Oklahoma
- Pennsylvania
  - Altoona, Pennsylvania, United States, 16602
    - University Orthopedics Center
  - Beaver, Pennsylvania, United States, 15009
    - Heritage Valley Medical Group, Inc.
  - Downingtown, Pennsylvania, United States, 19335
    - Brandywine Clinical Research
  - Duncansville, Pennsylvania, United States, 16635
    - Altoona Center for Clinical Research
  - Jenkintown, Pennsylvania, United States, 19046
    - The Clinical Trial Center LLC
  - Philadelphia, Pennsylvania, United States, 19152
    - The Arthritis Group
  - Philadelphia, Pennsylvania, United States, 19114
    - Founders Research Corporation
  - Wyomissing, Pennsylvania, United States, 19610
    - Clinical Research Center of Reading, LLC
- South Carolina
  - Little River, South Carolina, United States, 29566
    - Main Street Physician's Care - Waterway
  - Loris, South Carolina, United States, 29569
    - Main Street Physician's Care - Loris
  - North Myrtle Beach, South Carolina, United States, 29582
    - North Myrtle Beach Family Practice
- Tennessee
  - Jackson, Tennessee, United States, 38305
    - Clinical Research Solutions
  - Jackson, Tennessee, United States, 38305
    - Physicians Quality Care
  - Jefferson City, Tennessee, United States, 37760
    - PMG Research, Inc. d/b/a PMG Research of Knoxville
  - Knoxville, Tennessee, United States, 37909
    - PCET Research Center, LLC
  - Memphis, Tennessee, United States, 38119
    - Diagnostic Imaging PC
- Texas
  - Austin, Texas, United States, 78745
    - Tekton Research, Inc.
  - Austin, Texas, United States, 78726
    - ARC Clinical Research at Wilson Parke
  - Baytown, Texas, United States, 77521
    - Urgent Care MD's
  - Bedford, Texas, United States, 76021
    - Texas Orthopedic Specialists, PLLC
  - Dallas, Texas, United States, 75251
    - Galenos Research
  - Houston, Texas, United States, 77058
    - Centex Studies, Inc.
  - Houston, Texas, United States, 77084
    - BI Research Center
  - Houston, Texas, United States, 77030
    - Advances in Health
  - Houston, Texas, United States, 77024
    - Abigail R. Neiman, MD, PA
  - Houston, Texas, United States, 77036
    - Mercury Clinical Research, Inc.
  - Houston, Texas, United States, 77079
    - Memorial Pulmonology
  - Plano, Texas, United States, 75075
    - Clinical Investigations Of Texas
  - Richardson, Texas, United States, 75080
    - ClinRx Research
  - San Antonio, Texas, United States, 78229
    - Diagnostics Research Group
  - San Antonio, Texas, United States, 78213
    - Progressive Clinical Research, PA
  - San Antonio, Texas, United States, 78215
    - Sun Research Institute
  - San Antonio, Texas, United States, 78209
    - Quality Research, Inc.
  - San Antonio, Texas, United States, 78228
    - Panacea Clinical Research
  - San Antonio, Texas, United States, 78258
    - South Texas Radiology Imaging Centers
  - San Antonio, Texas, United States, 78230
    - Victorium Clinical Research
  - San Antonio, Texas, United States, 78258
    - DCT-Stone Oak, LLC dba Discovery Clinical Trials
  - San Antonio, Texas, United States, 78213
    - Lee Medical Associates PA
  - San Antonio, Texas, United States, 78229
    - Accurate Clinical Research Inc.
  - Southlake, Texas, United States, 76092
    - Envision Imaging
  - Sugar Land, Texas, United States, 77479
    - Oakbend Medical Center
  - Waxahachie, Texas, United States, 75165
    - ClinPoint Trials
  - Webester, Texas, United States, 77598
    - Mercury Clinical Research
  - Wichita Falls, Texas, United States, 76309
    - Grayline Clinical Drug Trials
  - Wichita Falls, Texas, United States, 76302
    - Clinics of North Texas
- Utah
  - Riverton, Utah, United States, 84065
    - Granger Medical Clinic-Riverton
- Virginia
  - Arlington, Virginia, United States, 22207
    - Millennium Clinical Trials, LLC
  - Charlottesville, Virginia, United States, 22911
    - Charlottesville Medical Research Center, LLC
  - Fairfax, Virginia, United States, 22031
    - Millennium Clinical Trials
  - Norfolk, Virginia, United States, 23502
    - National Clinical Research-Norfolk, Inc.
- Washington
  - Bellevue, Washington, United States, 98007
    - Northwest Clinical Research Center
  - Bellingham, Washington, United States, 98225
    - Optimed Research, LTD
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center
  - Seattle, Washington, United States, 98122
    - Seattle Rheumatology Associates
  - Seattle, Washington, United States, 98104
    - Swedish Medical Center Investigational Drug Services Pharmacy

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader
Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period
WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening
Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study
Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements

Exclusion Criteria:

Subjects exceeding protocol defined BMI or body weight limits
History of other diseases specified in the protocol (eg, inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments
Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer
A history of osteonecrosis or osteoporotic fracture
History of significant trauma or surgery to a knee, hip or shoulder within the previous year
Planned surgical procedure during the duration of the study
Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain
Signs or symptoms of carpal tunnel syndrome in the year prior to Screening
Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required
Contraindications to magnetic resonance imaging
History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or diclofenac) the subject could be randomized to receive or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of this NSAID is contraindicated
History of intolerance or hypersensitivity to acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated
Use of prohibited medications without the appropriate washout period prior to Screening or Initial Pain Assessment Period
History of cancer within 5 years of Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
Subjects with signs and symptoms of clinically significant cardiac disease as described in the protocol
Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities
History, diagnosis, or signs and symptoms of clinically significant neurological disease such as but not limited to peripheral or autonomic neuropathy
History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
History of known alcohol, analgesic or drug abuse within 2 years of Screening
Previous exposure to exogenous NGF or to an anti-NGF antibody
History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein
Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening
Evidence of protocol defined orthostatic hypotension at Screening
Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening
Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits
Presence of drugs of abuse in screening urine toxicology panel
Positive hepatitis B, hepatitis C or HIV test results indicative of current infection
Participation in other investigational drug studies within protocol defined time limits
Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study

Study Plan

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

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: NSAID Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks	Drug: NSAID Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
EXPERIMENTAL: Tanezumab 2.5 mg Subcutaneous injection of tanezumab 2.5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac ER) twice daily for 56 weeks	Biological: Tanezumab 2.5 mg Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks
EXPERIMENTAL: Tanezumab 5 mg Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac) twice daily for 56 weeks	Biological: Tanezumab 5 mg Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome Time Frame: Baseline up to Week 80	Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to [>=] 2 millimeters [mm]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.	Baseline up to Week 80
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome Time Frame: Baseline up to Week 80	Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.	Baseline up to Week 80
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 Time Frame: Baseline, Week 16	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.	Baseline, Week 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 Time Frame: Baseline, Week 16	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.	Baseline, Week 16
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16 Time Frame: Baseline, Week 16	PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome Time Frame: Baseline up to Week 80	Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.	Baseline up to Week 80
Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome Time Frame: Baseline up to Week 80	Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.	Baseline up to Week 80
Percentage of Participants With Individual Adjudicated Joint Safety Outcome Time Frame: Baseline up to Week 80	Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW >=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.	Baseline up to Week 80
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome Time Frame: Baseline up to Week 80	Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.	Baseline up to Week 80
Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome Time Frame: Baseline up to Week 80	Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture.	Baseline up to Week 80
Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome Time Frame: Baseline up to Week 80	Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.	Baseline up to Week 80
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Time Frame: Baseline, Weeks 56 and 80	Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral).	Baseline, Weeks 56 and 80
Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Time Frame: Baseline, Weeks 56 and 80	Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.	Baseline, Weeks 56 and 80
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Time Frame: Weeks 56 and 80	Progression of OA according to Bland-Altman as defined by a decrease JSW >=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function.	Weeks 56 and 80
Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Time Frame: Weeks 56 and 80	Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW >=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.	Weeks 56 and 80
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Time Frame: Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Change From Baseline in WOMAC Pain Subscale at Week 64 Time Frame: Baseline, Week 64	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.	Baseline, Week 64
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Time Frame: Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.	Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Change From Baseline in WOMAC Physical Function Subscale at Week 64 Time Frame: Baseline, Week 64	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.	Baseline, Week 64
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Time Frame: Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56	PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition.	Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 Time Frame: Baseline, Week 64	PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition.	Baseline, Week 64
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64	Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was >=50 percent and >= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and PGA of OA (score: 1 [very good] to 5 [very poor], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).	Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64	Percentage of participants with reduction in WOMAC pain intensity of >= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.	Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Time Frame: Baseline, Weeks 16, 24 and 56	WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than [>] 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.	Baseline, Weeks 16, 24 and 56
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64	Percentage of participants with reduction in WOMAC physical function of >=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.	Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Time Frame: Baseline, Weeks 16, 24 and 56	Percentage of participants with cumulative reduction (as percent) (> 0 %; >= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.	Baseline, Weeks 16, 24 and 56
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64	PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF.	Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56	Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.	Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56
Change From Baseline in Average Pain Score in the Index Joint at Week 64 Time Frame: Baseline, Week 64	Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.	Baseline, Week 64
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 Time Frame: Baseline, Week 64	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.	Baseline, Week 64
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 Time Frame: Baseline, Week 64	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.	Baseline, Week 64
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, 16, 24, 32, 40, 48 and 56 Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 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 Week 64 Time Frame: Baseline, Week 64	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.	Baseline, Week 64
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, 16, 24, 32, 40, 48 and 56 Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.	Baseline, Weeks 2, 4, 8, 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 Week 64 Time Frame: Baseline, Week 64	WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.	Baseline, Week 64
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Time Frame: Weeks 16, 24 and 56	WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.	Weeks 16, 24 and 56
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Time Frame: Baseline, Week 64	WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.	Baseline, Week 64
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Time Frame: Baseline, Weeks 8, 16, 24, 40, 56 and 64	Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.	Baseline, Weeks 8, 16, 24, 40, 56 and 64
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Time Frame: Baseline, Weeks 8, 16, 24, 40, 56 and 64	Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.	Baseline, Weeks 8, 16, 24, 40, 56 and 64
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Time Frame: Baseline, Weeks 8, 16, 24, 40, 56 and 64	Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.	Baseline, Weeks 8, 16, 24, 40, 56 and 64
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Time Frame: Baseline, Weeks 8, 16, 24, 40, 56 and 64	Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.	Baseline, Weeks 8, 16, 24, 40, 56 and 64
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Time Frame: Baseline, Weeks 8, 16, 24, 40, 56 and 64	Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.	Baseline, Weeks 8, 16, 24, 40, 56 and 64
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value Time Frame: Baseline, Weeks 8, 16, 24, 40, 56 and 64	EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.	Baseline, Weeks 8, 16, 24, 40, 56 and 64
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Time Frame: Weeks 16 and 56	TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied] and 1 question on 2 point scale [0 =No, 1=Yes]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction.	Weeks 16 and 56
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Time Frame: Weeks 16 and 56	The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Number of participants who responded for the specified question were reported.	Weeks 16 and 56
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Time Frame: Weeks 16 and 56	The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product. Number of participants who responded for the specified question were reported.	Weeks 16 and 56
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Time Frame: Weeks 16 and 56	The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess participant willingness to use drug again, participants responded using IRT on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Number of participants who responded for the specified question were reported.	Weeks 16 and 56
Number of Participants Who Withdrew Due to Lack of Efficacy Time Frame: Baseline up to Week 56	Number of participants who withdrew from treatment due to lack of efficacy have been reported here.	Baseline up to Week 56
Time to Discontinuation Due to Lack of Efficacy Time Frame: Baseline up to Week 56	Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.	Baseline up to Week 56
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56	In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.	Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Number of Participants Who Took Rescue Medication During Week 64 Time Frame: Week 64	In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during Week 64 were summarized.	Week 64
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56	In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.	Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Number of Days of Rescue Medication Used During Week 64 Time Frame: Week 64	In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 were summarized.	Week 64
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 Time Frame: Weeks 2, 4, 8 and 16	In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.	Weeks 2, 4, 8 and 16
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Time Frame: Baseline, Weeks 64 and 80	OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.	Baseline, Weeks 64 and 80
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis Time Frame: Baseline, Weeks 64 and 80	OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA.	Baseline, Weeks 64 and 80
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis Time Frame: Baseline, Weeks 64 and 80	Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA.	Baseline, Weeks 64 and 80
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis Time Frame: Baseline, Weeks 64 and 80	OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA.	Baseline, Weeks 64 and 80
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis Time Frame: Baseline, Weeks 64 and 80	OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA.	Baseline, Weeks 64 and 80
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Time Frame: Baseline, Weeks 64 and 80	OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.	Baseline, Weeks 64 and 80
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis Time Frame: Baseline, Weeks 64 and 80	OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA.	Baseline, Weeks 64 and 80
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis Time Frame: Baseline, Weeks 64 and 80	OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA.	Baseline, Weeks 64 and 80
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Time Frame: Baseline, Weeks 4, 8, 16, 24, 56 and 80	The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change >0), No change and worsening (Change less than [<] 0).	Baseline, Weeks 4, 8, 16, 24, 56 and 80
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 Time Frame: Baseline, Weeks 16 and 56	Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).	Baseline, Weeks 16 and 56
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 Time Frame: Baseline, Weeks 16 and 56	An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).	Baseline, Weeks 16 and 56
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 Time Frame: Baseline, Weeks 16 and 56	An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {<1500} counts moderate (1,500 - <6500 counts), and vigorous (>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).	Baseline, Weeks 16 and 56
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 Time Frame: Baseline, Weeks 16 and 56	An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - <1,500 counts) moderate (1,500 - <6,500 counts), and vigorous (>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A "bout" of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold.	Baseline, Weeks 16 and 56
Change From Baseline in Average Daily Step Count at Weeks 16 and 56 Time Frame: Baseline, Weeks 16 and 56	Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).	Baseline, Weeks 16 and 56
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Time Frame: Baseline up to Week 80	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs.	Baseline up to Week 80
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Time Frame: Baseline up to Week 80	Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.	Baseline up to Week 80
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline Time Frame: Baseline up to Week 80	Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9LLN, >1.1upper limit of normal(ULN); platelets <0.5LLN,>1.75ULN; Leukocytes <0.6LLN, >1.5ULN; Lymphocytes, Neutrophils <0.8LLN, >1.2ULN; Basophils,Eosinophils,Monocytes>1.2ULN; Prothrombin time/Intl. normalized ratio>1.1ULN; total bilirubin>1.5ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0ULN; total protein; albumin<0.8LLN, >1.2ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3ULN; Urate>1.2ULN; sodium<0.95LLN,>1.05ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9LLN, >1.1ULN; phosphate<0.8LLN, >1.2ULN; glucose<0.6LLN, >1.5ULN; HGB A1C >1.3ULN; creatine kinase>2.0ULN, specific gravity<1.003, >1.030; pH<4.5, >8;Urine erythrocytes,Leukocytes>=20.	Baseline up to Week 80
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline Time Frame: Baseline up to Week 80	Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9LLN, >1.1ULN; platelets <0.5LLN,>1.75upper limit of normal (ULN); white blood cell count<0.6LLN, >1.5ULN; Lymphocytes, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes <0.8LLN, >1.2ULN; Basophils, Eosinophils, Monocytes >1.2ULN; total bilirubin>1.5ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0ULN; total protein; albumin<0.8LLN, >1.2ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3ULN; Urate >1.2ULN; sodium <0.95LLN,>1.05ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9LLN, >1.1ULN; phosphate <0.8LLN, >1.2ULN; glucose <0.6LLN, >1.5ULN; Hemoglobin A1C >1.3ULN; creatine kinase >2.0ULN; specific gravity<1.003, >1.030; Urine erythrocytes,Leukocytes>=20; Hyaline Casts>=1.	Baseline up to Week 80
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80	Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80	Heart rate (pulse rate) was measured at sitting position.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 Time Frame: Baseline, Weeks 56 and 80	A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.	Baseline, Weeks 56 and 80
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 Time Frame: Baseline, Weeks 56 and 80	Heart rate was measured at sitting position.	Baseline, Weeks 56 and 80
Number of Participants With Confirmed Orthostatic Hypotension Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80	Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Time Frame: Baseline, Weeks 24, 56 and 80	The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.	Baseline, Weeks 24, 56 and 80
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80	NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Number of Participants With Anti-Tanezumab Antibodies Time Frame: Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80	Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).	Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

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

General Publications

Helpful Links

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

Study record dates

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

Study Major Dates

Study Start (ACTUAL)

July 21, 2015

Primary Completion (ACTUAL)

October 5, 2018

Study Completion (ACTUAL)

February 27, 2019

Study Registration Dates

First Submitted

July 19, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (ESTIMATE)

August 19, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A4091058
2012-003721-22 (EUDRACT_NUMBER)
OA 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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

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

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations