Chronic Pain Clinical Trial
Official title:
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
| Verified date | December 2019 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 3021 |
| Est. completion date | February 27, 2019 |
| Est. primary completion date | October 5, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | CMAX Clinical Research Pty Ltd | Adelaide | South Australia |
| Australia | Royal Adelaide Hospital Pharmacy | Adelaide | South Australia |
| Australia | Genesis Research Services | Broadmeadow | New South Wales |
| Australia | Emeritus Research | Camberwell | Victoria |
| Australia | Hunter Imaging Group | Cardiff | New South Wales |
| Australia | Optimus Clinical Research Pty Ltd | Kogarah | New South Wales |
| Australia | Capital Radiology-Clayton | Melbourne | Victoria |
| Australia | Capital Radiology-Malvern | Melbourne | Victoria |
| Australia | Southern Radiology | Miranda | New South Wales |
| Australia | SKG Radiology Hollywood | Nedlands | Western Australia |
| Australia | Bensons Radiology | North Adelaide | South Australia |
| Australia | Royal Hospital for Women | Randwick | New South Wales |
| Australia | AusTrials Pty Ltd | Sherwood | Queensland |
| Australia | Castlereagh Imaging | St Leonards | New South Wales |
| Australia | Royal North Shore Hospital | St Leonards | New South Wales |
| Australia | Australian Clinical Research Network | Sydney | New South Wales |
| Australia | Spectrum Medical Imaging | Sydney | New South Wales |
| Australia | RK Will Pty Ltd | Victoria Park | Western Australia |
| Brazil | CMIP-Centro Mineiro de Pesquisa LTDA | Juiz de Fora | Minas Gerais |
| Brazil | CCBR - Centro de Pesquisas e Analises Clinicas LTDA | Rio De Janeiro | RJ |
| Brazil | CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda | Sao Paulo | SP |
| Bulgaria | Diagnostic Consultative Center "Sveti Georgi" EOOD | Plovdiv | |
| Bulgaria | Medical Center "Health for all" - EOOD | Plovdiv | |
| Bulgaria | UMHAT Kaspela - EOOD | Plovdiv | |
| Bulgaria | UMHAT Kaspela - EOOD Rheumatology Clinic | Plovdiv | |
| Bulgaria | "Medical Center Teodora" EOOD | Ruse | |
| Bulgaria | "Medical Center- Dr. Hayvazov" EOOD | Sofia | |
| Bulgaria | Diagnostic Consultative Center 17 Sofia EOOD | Sofia | |
| Bulgaria | UMHAT "Sofiamed" OOD, Block 2 | Sofia | |
| Bulgaria | UMHAT Sveti Ivan Rilski- EAD | Sofia | |
| Colombia | Centro de Investigacion en Reumatologia y Especialidades Medicas SAS CIREEM SAS | Bogota | Bogota DC |
| Colombia | Centro Integral de Reumatologia Reumalab S.A.S. | Medellin | Antioquia |
| Croatia | Medicinski centar Kuna&Peric | Zagreb | |
| Japan | Sonodakai Joint Replacement Center Hospital | Adachi-ku | Tokyo |
| Japan | Okubo Hospital | Akashi | Hyogo |
| Japan | Mazda Hospital | Aki-gun | Hiroshima |
| Japan | National Hospital Organization Chiba Medical Center | Chiba | |
| Japan | Takahashi Orthopedics Clinic | Chitose | Hokkaido |
| Japan | Medical Plaza Edogawa | Edogawa-ku | Tokyo |
| Japan | Sato Orthopaedic Clinic | Edogawa-ku | Tokyo |
| Japan | Fujieda Municipal General Hospital | Fujieda | Shizuoka |
| Japan | Chihaya Hospital | Fukuoka | |
| Japan | Kuroda Orthopedic Hospital | Fukuoka | |
| Japan | Funabashi Municipal Medical Center | Funabashi | Chiba |
| Japan | Fussa Hospital | Fussa | Tokyo |
| Japan | JA Shizuoka Kohseiren Enshu Hospital | Hamamatsu | Shizuoka |
| Japan | Japanese Red Cross Hamamatsu Hospital | Hamamatsu | Shizuoka |
| Japan | Sobajima Clinic/Orthopedics | Higashiosaka | Osaka |
| Japan | Omuro Orthopedic Clinic | Himeji | Hyogo |
| Japan | Hiroshima Prefectural Hospital | Hiroshima | |
| Japan | Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | Hiroshima | |
| Japan | Rinku General Medical Center | Izumisano | Osaka |
| Japan | Shimane University Hospital | Izumo | Shimane |
| Japan | Medical corporate corporation hoshikai Onishi medical clinic | Kako-gun | Hyogo |
| Japan | National Hospital Organization Kanazawa Medical Center | Kanazawa | Ishikawa |
| Japan | Kokan Clinic | Kawasaki | Kanagawa |
| Japan | Kishiwada Tokushukai Hospital | Kishiwada | Osaka |
| Japan | Kanbara Clinic | Kitakyushu | Fukuoka |
| Japan | Kobe Red Cross Hospital | Kobe | Hyogo |
| Japan | Jukoukai hospital | Koto-ku | Tokyo |
| Japan | Kumamoto Orthopaedic Hospital | Kumamoto | |
| Japan | Medical Corporation Emu Emukai, Matterhorn Rehabilitation Hospital | Kure | Hiroshima |
| Japan | Medical Corporation Okimoto Clinic | Kure | Hiroshima |
| Japan | Hidaka Orthopedic Hospital | Kurume | Fukuoka |
| Japan | Zenshukai Hospital | Maebashi | Gunma |
| Japan | Matsudo City General Hospital | Matsudo | Chiba |
| Japan | Marunouchi Hospital | Matsumoto | Nagano |
| Japan | Kitasato University Kitasato Institute Hospital | Minato-ku | Tokyo |
| Japan | Mito Saiseikai General Hospital | Mito | Ibaraki |
| Japan | Obase Hospital | Miyako-gun | Fukuoka |
| Japan | Obihiro Orthopaedic Hospital | Obihiro | Hokkaido |
| Japan | Nagayoshi General Hospital | Osaka | |
| Japan | Social Welfare Organization Saiseikai Imperial Gift Foundation,Inc. Osaka Saiseikai Nakatsu Hospital | Osaka-shi | Osaka |
| Japan | Iwasaki Orthopedic Surgery | Saitama | |
| Japan | Saitama Municipal Hospital | Saitama | |
| Japan | Nakajo Orthopedic Clinic | Sendai | Miyagi |
| Japan | Tamagawa Hospital | Setagaya-ku | Tokyo |
| Japan | Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital | Shinagawa-ku | Tokyo |
| Japan | Ohimachi Orthopaedic Clinic | Shinagawa-ku | Tokyo |
| Japan | Osaka University Hospital | Suita | Osaka |
| Japan | Ikeda Kinen Hospital | Sukagawa | Fukushima |
| Japan | National Hospital Organization Toyohashi Medical Center | Toyohashi | Aichi |
| Japan | Himeno Hospital | Yamegun | Fukuoka |
| Japan | Misugikai Medical Corporation Otokoyama Hospital | Yawata | Kyoto |
| Japan | Japan Organization of Occupational Health and Safety Sanin Rosai Hospital | Yonago | Tottori |
| Japan | Oita University Hospital | Yufu | Oita |
| Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
| Korea, Republic of | Department of Radiology | Daegu | |
| Korea, Republic of | Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University Medical Center | Daegu | |
| Korea, Republic of | Chungnam National University Hospital | Daejeon | |
| Korea, Republic of | Clinical Trial Center Pharmacy | Daejeon | |
| Korea, Republic of | Department of Radiology | Daejeon | |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Department of Radiology | Gwangju | |
| Korea, Republic of | Pharmacy of Clinical Trial Center | Gwangju | |
| Korea, Republic of | Clinical Research Pharmacy | Seoul | |
| Korea, Republic of | Clinical Research Pharmacy, SMG SNU Boramae Medical Center | Seoul | |
| Korea, Republic of | Clinical Trial Center Pharmacy | Seoul | |
| Korea, Republic of | Clinical Trial Center Pharmacy | Seoul | |
| Korea, Republic of | Clinical Trial Pharmacy | Seoul | |
| Korea, Republic of | Clinical Trial Pharmacy | Seoul | |
| Korea, Republic of | Clinical Trials Center Pharmacy | Seoul | |
| Korea, Republic of | Department of Clinical Research Pharmacy, Konkuk University Medical Center | Seoul | |
| Korea, Republic of | Department of Clinical Research Pharmacy, SMG-SNU Boramae Medical Center | Seoul | |
| Korea, Republic of | Department of Orthopedic Surgery, Samsung Medical Center | Seoul | |
| Korea, Republic of | Department of Radiology | Seoul | |
| Korea, Republic of | Department of Radiology | Seoul | |
| Korea, Republic of | Department of Radiology | Seoul | |
| Korea, Republic of | Department of Radiology | Seoul | |
| Korea, Republic of | Department of Radiology | Seoul | |
| Korea, Republic of | Department of Radiology | Seoul | |
| Korea, Republic of | Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center | Seoul | |
| Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul | |
| Korea, Republic of | Konkuk University Medical Center | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | SMG-SNU Boramae Medical Center | Seoul | |
| Korea, Republic of | The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | |
| Korea, Republic of | Yonsei University Health System, Severance Hospital | Seoul | |
| Korea, Republic of | Clinical Trial Pharmacy | Yangcheon-gu, Seoul | |
| Lithuania | Saules seimos medicinos centras | Kaunas | |
| Lithuania | Klaipeda University Hospital | Klaipeda | |
| Lithuania | Republican Siauliai Hospital | Siauliai | |
| Mexico | Centro Hospitalario Mac, S.A. de C.V. | Guadajara | Jalisco |
| Mexico | Consultorio Medico del Dr. Federico Galvan Villegas | Guadalajara | Jalisco |
| New Zealand | Auckland Bone Density | Auckland | |
| New Zealand | Auckland Bone Density Ltd | Auckland | |
| New Zealand | Auckland Radiology Parnell Branch | Auckland | |
| New Zealand | North Shore Hospital, Waitemata District Health Board | Auckland | |
| New Zealand | Optimal Clinical Trials | Auckland | |
| New Zealand | South Pacific Clinical Trials | Auckland | |
| New Zealand | Southern Clinical Trials- Waitemata Ltd | Auckland | |
| New Zealand | Star Unit, North Shore Hospital, Waitemata District Health Board | Auckland | |
| New Zealand | The Radiology Group | Auckland | |
| New Zealand | TRG Imaging Lincoln Road | Auckland | |
| New Zealand | Southern Clinical Trials Ltd | Christchurch | |
| New Zealand | Otago Radiology | Dunedin | Otago |
| New Zealand | RMC Medical Research Ltd | Dunedin | Otago |
| New Zealand | Collingwood Street Pharmacy | Nelson | |
| New Zealand | Nelson Radiology | Nelson | |
| New Zealand | Porter Rheumatology Ltd | Nelson | |
| New Zealand | Lakeland Clinical Trials | Rotorua | BOP |
| New Zealand | Bay Radiology | Tauranga | |
| New Zealand | Clinical Horizons NZ Ltd | Tauranga | |
| New Zealand | P3 Research Ltd | Tauranga | |
| New Zealand | P3 Research Ltd | Wellington | |
| New Zealand | Pacific Radiology | Wellington | |
| Peru | Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios | Cayma | Arequipa |
| Peru | ABK REUMA S.R.L. de Medicentro Biociencias/BIO CIENCIAS PERU S.R.L. | Lima | |
| Peru | Centro de Investigación Reumatología CAA-Clinica Anglo Americana | Lima | |
| Peru | Centro de Investigaciones Medicas-Hospital Maria Auxiliadora | Lima | |
| Peru | Investigaciones Clinicas S.A.C. / Instituto de Ginecologia y Reproduccion S.A. | Lima | |
| Peru | Investigaciones Clinicas S.A.C./Instituto de Ginecologia y Reproduccion S.A. | Lima | |
| Peru | Investigaciones en Reumatologia / Centro Medico Corpac S.A. | Lima | |
| Peru | Centro De Investigacion Clinica Trujillo EIRL/Clinica Peruano Americana S.A. | Trujillo | LA Libertad |
| Philippines | Manila Doctors Hospital | Manila | |
| Philippines | Philippine General Hospital | Manila | NCR |
| Russian Federation | Moscow Municipal Rheumatology Center | Moscow | |
| Russian Federation | SBHI "City Clinical Hospital No. 1 n.a N.I. Pirogov" | Moscow | |
| Russian Federation | SBHI "City Clinical Hospital No. 1 n.a. N.I. Pirogov" | Moscow | |
| Russian Federation | Federal State Budgetary Scientific Institution | Novosibirsk | |
| Russian Federation | Federal State Budgetary Scientific Research institution of fundamental and clinical immunology | Novosibirsk | |
| Russian Federation | State Budgetary Institution of Ryazan Region | Ryazan | |
| Russian Federation | FSBI 'SRITO n.a. R.R. Vreden' MoH RF | Saint Petersburg | |
| Russian Federation | Limited Liability Company "Medical Center "Reavita Med SPb" | Saint Petersburg | |
| Russian Federation | Medical Technologies Ltd | Saint Petersburg | |
| Russian Federation | Medinet LLC | Saint Petersburg | |
| Serbia | Institute for Rehabilitation | Belgrade | |
| Serbia | Institute of Rheumatology | Belgrade | |
| Serbia | Institute for treatment and rehabilitation "Niska Banja" | Niska Banja | |
| Serbia | Special Hospital for Rheumatic Diseases Novi Sad | Novi Sad | |
| Serbia | General hospital "Dr Laza K. Lazarevic" Sabac | Sabac | |
| Slovakia | Nestatna Reumatologicka Ambulancia, Poliklinika Karlova Ves | Bratislava | |
| Slovakia | Reumatologia s.r.o. | Bratislava | |
| Slovakia | MUDr. STRANAI s.r.o. | Kosice | |
| Slovakia | Reum.hapi s.r.o. | Nove Mesto nad Vahom | |
| Slovakia | MEDIPA s.r.o. | Piestany | |
| Slovakia | Thermium s.r.o. | Piestany | |
| Taiwan | Changhua Christian Hospital | Changhua | |
| Taiwan | Changhua Christian Hospital Clinical Trial Pharmacy | Changhua | |
| Taiwan | Chang Gung Memorial Hospital-Kaohsiung Branch | Kaohsiung | |
| Taiwan | Chang Gung Memorial Hospital-Kaohsiung Branch Clinical Trial Pharmacy | Kaohsiung | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | Chung Shan Medical University Hospital | Taichung | |
| Taiwan | Chung Shan Medical University Hospital Clinical Trial Pharmacy | Taichung | |
| Taiwan | Department of Pharmacy, China Medical University Hospital | Taichung | |
| Ukraine | Regional Communal Institution Chernivtsi Regional Clinical Hospital | Chernivtsi | |
| Ukraine | Communal Non-profit Institution "City Clinical Hospital No.27" of Kharkiv City Council | Kharkiv | |
| Ukraine | Government Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine" | Kharkiv | |
| Ukraine | Chair of Internal Medicine #2 | Kyiv | |
| Ukraine | Clinic of NI "NSC"M.D.Strazhesko Institute of Cardiology" of NAMS of Ukraine, | Kyiv | |
| Ukraine | Clinic of SI "Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine" | Kyiv | |
| Ukraine | Clinic of SI Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine | Kyiv | |
| Ukraine | Kyiv City Clinical Hospital 3,Rheumatology Department | Kyiv | |
| Ukraine | National Medical University named after O O Bogomolets, | Kyiv | |
| Ukraine | Oleksandrivska Clinical Hospital Of Kyiv | Kyiv | |
| Ukraine | Polyclinic Of Administration of Medical Services and Rehabilitation of SSHC Artem | Kyiv | |
| Ukraine | Polyclinic of Administration of Medical Services and Rehabilitation of State Stock Holding Company | Kyiv | |
| Ukraine | Communal Non-profit Institution "City Clinical Hospital #5 of Lviv", Therapeutics Department | Lviv | |
| Ukraine | Communal Institution "Odesa Regional Clinical Hospital" | Odesa | |
| Ukraine | Multi-field Medical Center (University Clinic No.1) of Odesa National Medical University, | Odesa | |
| Ukraine | Communal Institution Ternopil University Hospital | Ternopil | |
| Ukraine | Communal Non-commercial Enterprise "Vinnytsia City Clinical Hospital No 1" | Vinnytsia | |
| Ukraine | Medical Clinical Investigational Centre of Medical Centre Health Clinic LTD | Vinnytsia | |
| Ukraine | Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Medical | Vinnytsia | |
| Ukraine | Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov, Rheumatology Department, | Vinnytsia | |
| Ukraine | Vinnytsya Medical National University named after M.I. Pyrogov, Chair of Internal Medicine #3 | Vinnytsia | |
| Ukraine | Communal Institution Zaporizhzhya Regional Clinical Hospital | Zaporizhzhya | |
| United States | Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico |
| United States | Lovelace Scientific Resources Inc. | Albuquerque | New Mexico |
| United States | New Mexico Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico |
| United States | University Orthopedics Center | Altoona | Pennsylvania |
| United States | Advanced Research Center | Anaheim | California |
| United States | Orange County Research Institute | Anaheim | California |
| United States | Millennium Clinical Trials, LLC | Arlington | Virginia |
| United States | Atlanta Center for Medical Research | Atlanta | Georgia |
| United States | Perimeter Institute for Clinical Research, Inc. DBA:/PICR Clinic | Atlanta | Georgia |
| United States | JEM Research Institute | Atlantis | Florida |
| United States | Masters of Clinical Research, Inc. | Augusta | Georgia |
| United States | ARC Clinical Research at Wilson Parke | Austin | Texas |
| United States | Tekton Research, Inc. | Austin | Texas |
| United States | AARDS Research, Inc. | Aventura | Florida |
| United States | Baton Rouge General Medical Center-Bluebonnet | Baton Rouge | Louisiana |
| United States | Baton Rouge General Medical Center-Clinical Trials Office | Baton Rouge | Louisiana |
| United States | Baton Rouge General Medical Center-Internal Medicine Clinic | Baton Rouge | Louisiana |
| United States | Baton Rouge General Medical Center-Midcity | Baton Rouge | Louisiana |
| United States | Great Lakes Research Group, Incorporated | Bay City | Michigan |
| United States | Urgent Care MD's | Baytown | Texas |
| United States | Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania |
| United States | Texas Orthopedic Specialists, PLLC | Bedford | Texas |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | CITrials | Bellflower | California |
| United States | Optimed Research, LTD | Bellingham | Washington |
| United States | Osteoporosis Medical Center | Beverly Hills | California |
| United States | Achieve Clinical Research, LLC | Birmingham | Alabama |
| United States | Alabama Clinical Therapeutics, LLC | Birmingham | Alabama |
| United States | Alabama Orthopaedic Surgeons | Birmingham | Alabama |
| United States | Central Alabama Research | Birmingham | Alabama |
| United States | River Birch Research Alliance, LLC | Blue Ridge | Georgia |
| United States | RASF-Clinical Research, Inc | Boca Raton | Florida |
| United States | Idaho Sports Medicine Institute | Boise | Idaho |
| United States | Injury Care Research, LLC | Boise | Idaho |
| United States | Orthopedic Research Institute | Boynton Beach | Florida |
| United States | New England Research Associates, LLC | Bridgeport | Connecticut |
| United States | Drug Trials Brooklyn | Brooklyn | New York |
| United States | NYU Langone Ambulatory Care Brooklyn Heights | Brooklyn | New York |
| United States | SPRI Clinical Trials, LLC | Brooklyn | New York |
| United States | Meridien Research | Brooksville | Florida |
| United States | Hope Clinical Research | Canoga Park | California |
| United States | Med Center | Carmichael | California |
| United States | Onyx Clinical Research | Caro | Michigan |
| United States | Valley Medical Research/Valley Medical Primary Care | Centerville | Ohio |
| United States | Core Healthcare Group | Cerritos | California |
| United States | Charlottesville Medical Research Center, LLC | Charlottesville | Virginia |
| United States | Chicago Clinical Research Institute Inc. | Chicago | Illinois |
| United States | Great Lakes Clinical Trials | Chicago | Illinois |
| United States | Medex Healthcare Research, Inc. | Chicago | Illinois |
| United States | Northwestern Memorial Hospital-Arkes Pavilion, Diagnostic Testing Center | Chicago | Illinois |
| United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | CTI Clinical Research Center | Cincinnati | Ohio |
| United States | Hightop Medical Research Center | Cincinnati | Ohio |
| United States | New Horizons Clinical Research | Cincinnati | Ohio |
| United States | Orthopaedic Associates of West Florida | Clearwater | Florida |
| United States | Tampa Bay Medical Research, Inc | Clearwater | Florida |
| United States | University of Missouri Health Care | Columbia | Missouri |
| United States | University of Missouri Health Care-Investigational Pharmacy | Columbia | Missouri |
| United States | University of Missouri School of Medicine- Clinical Research Center | Columbia | Missouri |
| United States | Aventiv Research Inc. | Columbus | Ohio |
| United States | Optimed Research LTD | Columbus | Ohio |
| United States | Remington-Davis, Incorporated | Columbus | Ohio |
| United States | Pleitez Medical Clinic | Covina | California |
| United States | Klein & Associates, M.D., P.A. | Cumberland | Maryland |
| United States | Galenos Research | Dallas | Texas |
| United States | Clinical Research Center of CT | Danbury | Connecticut |
| United States | Dayton Clinical Research | Dayton | Ohio |
| United States | PriMed Clinical Research | Dayton | Ohio |
| United States | Midland Florida Clinical Research Center, LLC | DeLand | Florida |
| United States | Mountain View Clinical Research, Inc | Denver | Colorado |
| United States | Mountain View Clinical Research, Inc. | Denver | Colorado |
| United States | Brandywine Clinical Research | Downingtown | Pennsylvania |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | Otrimed Corporation | Edgewood | Kentucky |
| United States | Triwest Research Associates, LLC | El Cajon | California |
| United States | T. Joseph Raoof MD, INC/Encino Research Center | Encino | California |
| United States | San Diego Imaging Escondido | Escondido | California |
| United States | MediSphere Medical Research Center, LLC | Evansville | Indiana |
| United States | Med Investigations, Inc. | Fair Oaks | California |
| United States | Millennium Clinical Trials | Fairfax | Virginia |
| United States | Lillestol Research, LLC | Fargo | North Dakota |
| United States | Plains Clinical Research Center, LLC | Fargo | North Dakota |
| United States | Centre for Rheumatology, Immunology and Arthritis | Fort Lauderdale | Florida |
| United States | S&W Clinical Research | Fort Lauderdale | Florida |
| United States | Clinical Physiology Associates | Fort Myers | Florida |
| United States | IMA | Fort Myers | Florida |
| United States | Arthritis Treatment Center | Frederick | Maryland |
| United States | Neuro-Pain Medical Center | Fresno | California |
| United States | Research Center of Fresno, Inc. | Fresno | California |
| United States | Arthritis Center of North Georgia | Gainesville | Georgia |
| United States | Center for Advanced Research & Education | Gainesville | Georgia |
| United States | SIMEDHealth, LLC | Gainesville | Florida |
| United States | Collaborative Neuroscience Network, LLC. | Garden Grove | California |
| United States | Allied Clinical Research | Gold River | California |
| United States | Orthopaedic Associates of Michigan, PC | Grand Rapids | Michigan |
| United States | Klein & Associates, M.D., P.A. | Hagerstown | Maryland |
| United States | Drug Trials America | Hartsdale | New York |
| United States | South Florida Clinical Trials | Hialeah | Florida |
| United States | Pines Clinical Research Inc. | Hollywood | Florida |
| United States | East-West Medical Research Institute | Honolulu | Hawaii |
| United States | CHI St. Vincent Medical Group Hot Springs | Hot Springs | Arkansas |
| United States | Abigail R. Neiman, MD, PA | Houston | Texas |
| United States | Advances in Health | Houston | Texas |
| United States | BI Research Center | Houston | Texas |
| United States | Centex Studies, Inc. | Houston | Texas |
| United States | Memorial Pulmonology | Houston | Texas |
| United States | Mercury Clinical Research, Inc. | Houston | Texas |
| United States | HealthCare Partners Clinical Research, LLC. | Huntington Beach | California |
| United States | Marvel Clinical Research LLC | Huntington Beach | California |
| United States | Rheumatology Associates of North Alabama, PC | Huntsville | Alabama |
| United States | Institute Of Arthritis Research | Idaho Falls | Idaho |
| United States | Clinical Research Solutions | Jackson | Tennessee |
| United States | Physicians Quality Care | Jackson | Tennessee |
| United States | Care Partners Clinical Research | Jacksonville | Florida |
| United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | PMG Research, Inc. d/b/a PMG Research of Knoxville | Jefferson City | Tennessee |
| United States | The Clinical Trial Center LLC | Jenkintown | Pennsylvania |
| United States | Kettering Medical Center | Kettering | Ohio |
| United States | PCET Research Center, LLC | Knoxville | Tennessee |
| United States | BioSolutions Clinical Research Center | La Mesa | California |
| United States | eStudySite | La Mesa | California |
| United States | Arthritis & Osteoporosis Medical Center | La Palma | California |
| United States | Centex Studies, Inc. | Lake Charles | Louisiana |
| United States | NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center | Lake Success | New York |
| United States | NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center, Infusion Center | Lake Success | New York |
| United States | NYU Langone Rheumatology Associates Long Island | Lake Success | New York |
| United States | Center For United Research, Inc. | Lakewood | California |
| United States | June D.O. PC | Lansing | Michigan |
| United States | Advanced Biomedical Research of America | Las Vegas | Nevada |
| United States | Affiliated Clinical Research, Inc. | Las Vegas | Nevada |
| United States | Clinical Research Consortium | Las Vegas | Nevada |
| United States | G. Timothy Kelly, MD | Las Vegas | Nevada |
| United States | Impact Clinical Trials | Las Vegas | Nevada |
| United States | Office of Robert P. Kaplan, DO | Las Vegas | Nevada |
| United States | Office of Stephen H. Miller, MD | Las Vegas | Nevada |
| United States | Northstate Clinical Research, PLLC | Lenoir | North Carolina |
| United States | Delaware Arthritis | Lewes | Delaware |
| United States | Central Kentucky Research Associates, Inc. | Lexington | Kentucky |
| United States | Physician Research Collaboration, LLC | Lincoln | Nebraska |
| United States | Main Street Physician's Care - Waterway | Little River | South Carolina |
| United States | Chrystal Johnson | Little Rock | Arkansas |
| United States | KLR Business Group, Inc., dba Arkansas Clinical Research | Little Rock | Arkansas |
| United States | Larry Watkins, MD | Little Rock | Arkansas |
| United States | Lynn Institute of the Ozarks | Little Rock | Arkansas |
| United States | Collaborative Neuroscience Network, LLC. | Long Beach | California |
| United States | Main Street Physician's Care - Loris | Loris | South Carolina |
| United States | Aeon Research, Inc. | Los Angeles | California |
| United States | American Institute of Research | Los Angeles | California |
| United States | IMD Medical Group | Los Angeles | California |
| United States | InterMed Medical Group | Los Angeles | California |
| United States | Drug Studies America | Marietta | Georgia |
| United States | Diagnostic Imaging PC | Memphis | Tennessee |
| United States | Advanced Clinical Research | Meridian | Idaho |
| United States | Ferguson Family Medicine | Mesa | Arizona |
| United States | Center for Arthritis and Rheumatic Diseases | Miami | Florida |
| United States | Clintex Research Group | Miami | Florida |
| United States | Columbus Clinical Services LLC | Miami | Florida |
| United States | International Research Associates, LLC | Miami | Florida |
| United States | Larkin Imaging Center | Miami | Florida |
| United States | M&M Medical Center, Inc. | Miami | Florida |
| United States | New Horizon Research Center | Miami | Florida |
| United States | Pharmax Research Clinic, Inc. | Miami | Florida |
| United States | Quality Research & Medical Center LLC | Miami | Florida |
| United States | Coastal Clinical Research, Inc. | Mobile | Alabama |
| United States | Catalina Research Institute, LLC | Montclair | California |
| United States | Lenox Hill Radiology | New York | New York |
| United States | Manhattan Medical Research Practice PLLC | New York | New York |
| United States | The Medical Research Network, LLC | New York | New York |
| United States | Javed Rheumatology Associates, Inc. | Newark | Delaware |
| United States | Better Health Clinical Research, Inc. | Newnan | Georgia |
| United States | National Clinical Research-Norfolk, Inc. | Norfolk | Virginia |
| United States | Providence Clinical Research | North Hollywood | California |
| United States | North Myrtle Beach Family Practice | North Myrtle Beach | South Carolina |
| United States | Renaissance Imaging Medical Associates, Inc | Northridge | California |
| United States | Affinity Clinical Research Institute | Oak Lawn | Illinois |
| United States | Southwest Center for Healthy Joints, S.C. | Oak Lawn | Illinois |
| United States | American Family Medical | Ocala | Florida |
| United States | Renstar Medical Research | Ocala | Florida |
| United States | Sensible Healthcare, LLC. | Ocoee | Florida |
| United States | Health Research of Oklahoma | Oklahoma City | Oklahoma |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Journey Research, Inc. | Oldsmar | Florida |
| United States | Olive Branch Family Medical Center | Olive Branch | Mississippi |
| United States | Sunshine Research Center | Opa-locka | Florida |
| United States | NRC Research Institute | Orange | California |
| United States | Compass Research, LLC | Orlando | Florida |
| United States | Omega Research Consultants, LLC | Orlando | Florida |
| United States | Rheumatology Associates of Central Florida, P.A. | Orlando | Florida |
| United States | Mid-America Physiatrists, P.A. | Overland Park | Kansas |
| United States | Oviedo Medical Research, LLC | Oviedo | Florida |
| United States | Advances in Medicine | Palm Desert | California |
| United States | Pensacola Research Consultants, Inc., d.b.a. Avanza Medical Research Center | Pensacola | Florida |
| United States | Sacred Heart Orthopedics | Pensacola | Florida |
| United States | Methodist Medical Center of Illinois | Peoria | Illinois |
| United States | Methodist Research Administration Office | Peoria | Illinois |
| United States | UnityPoint Clinic Rheumatology | Peoria | Illinois |
| United States | Founders Research Corporation | Philadelphia | Pennsylvania |
| United States | The Arthritis Group | Philadelphia | Pennsylvania |
| United States | Arizona Arthritis & Rheumatology Associates, P.C. | Phoenix | Arizona |
| United States | Arizona Research Center | Phoenix | Arizona |
| United States | Great Lakes Research Group | Pinconning | Michigan |
| United States | Clinical Investigations of Texas | Plano | Texas |
| United States | Orthopaedic Center of South Florida | Plantation | Florida |
| United States | St. Johns Center for Clinical Research | Ponte Vedra | Florida |
| United States | Accord Clinical Research, LLC | Port Orange | Florida |
| United States | Progressive Medical Research | Port Orange | Florida |
| United States | ActivMed Practices & Research, Inc. | Portsmouth | New Hampshire |
| United States | Phoenix Medical Research, Inc. | Prairie Village | Kansas |
| United States | Beacon Clinical Research, LLC | Quincy | Massachusetts |
| United States | Wake Internal Medicine Consultants, Inc | Raleigh | North Carolina |
| United States | Wake Research Associates, LLC | Raleigh | North Carolina |
| United States | ClinRX Research | Richardson | Texas |
| United States | Probe Clinical Research Corporation | Riverside | California |
| United States | Granger Medical Clinic-Riverton | Riverton | Utah |
| United States | AAIR Research Center | Rochester | New York |
| United States | Michigan Orthopaedic Spine Surgeons | Rochester Hills | Michigan |
| United States | OrthoIllinois | Rockford | Illinois |
| United States | Quest Diagnostics | Rockford | Illinois |
| United States | Center for Clinical Trials of Sacramento, Inc. | Sacramento | California |
| United States | Clinical Trials Research | Sacramento | California |
| United States | Northern California Research | Sacramento | California |
| United States | University of California, Davis Health System | Sacramento | California |
| United States | University of California, Davis Medical Center | Sacramento | California |
| United States | Advance Clinical Research, Inc. | Saint Louis | Missouri |
| United States | Medex Healthcare Research, Inc. | Saint Louis | Missouri |
| United States | Meridien Research | Saint Petersburg | Florida |
| United States | Accurate Clinical Research Inc. | San Antonio | Texas |
| United States | DCT-Stone Oak, LLC dba Discovery Clinical Trials | San Antonio | Texas |
| United States | Diagnostics Research Group | San Antonio | Texas |
| United States | Lee Medical Associates PA | San Antonio | Texas |
| United States | Panacea Clinical Research | San Antonio | Texas |
| United States | Progressive Clinical Research, PA | San Antonio | Texas |
| United States | Quality Research, Inc. | San Antonio | Texas |
| United States | South Texas Radiology Imaging Centers | San Antonio | Texas |
| United States | Sun Research Institute | San Antonio | Texas |
| United States | Victorium Clinical Research | San Antonio | Texas |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | San Diego Imaging, Kearny Mesa | San Diego | California |
| United States | Sharp and Children's MRI Center, LLC | San Diego | California |
| United States | Artemis Institute for Clinical Research | San Marcos | California |
| United States | CITrials | Santa Ana | California |
| United States | Syrentis Clinical Research | Santa Ana | California |
| United States | Gulfcoast Research Institute, LLC | Sarasota | Florida |
| United States | Kennedy White Orthopaedic Center | Sarasota | Florida |
| United States | Valley Pain Consultants | Scottsdale | Arizona |
| United States | Seattle Rheumatology Associates | Seattle | Washington |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | Swedish Medical Center Investigational Drug Services Pharmacy | Seattle | Washington |
| United States | Landmark Internal Medicine | Southaven | Mississippi |
| United States | Envision Imaging | Southlake | Texas |
| United States | Springboro Health Center | Springboro | Ohio |
| United States | Stamford Therapeutics Consortium | Stamford | Connecticut |
| United States | Atlanta Orthopaedic Institute, LLC | Stockbridge | Georgia |
| United States | Oakbend Medical Center | Sugar Land | Texas |
| United States | Precision Clinical Research, LLC. | Sunrise | Florida |
| United States | Herman Clinical Research, LLC | Suwanee | Georgia |
| United States | Phoenix Clinical Research, LLC. | Tamarac | Florida |
| United States | BayCare Medical Group, Inc | Tampa | Florida |
| United States | Clinical Research of West Florida, Inc. | Tampa | Florida |
| United States | Stedman Clinical Trials | Tampa | Florida |
| United States | Clinical Research Consortium | Tempe | Arizona |
| United States | Compass Research North LLC | The Villages | Florida |
| United States | Shariar Cohen, MD Corp. | Thousand Oaks | California |
| United States | Westlake Medical Research | Thousand Oaks | California |
| United States | AC Clinical Research | Tiffin | Ohio |
| United States | Bone Joint & Spine Surgeons, Inc. | Toledo | Ohio |
| United States | Glendale Medical Center | Toledo | Ohio |
| United States | Ocean Rheumatology, PA | Toms River | New Jersey |
| United States | Medical Research Associates Inc. | Traverse City | Michigan |
| United States | Premier Research | Trenton | New Jersey |
| United States | Oakland Medical Research Center | Troy | Michigan |
| United States | Noble Clinical Research, LLC | Tucson | Arizona |
| United States | Quality of Life Medical & Research Centers, LLC | Tucson | Arizona |
| United States | Tucson Orthopaedic Institute - Research Center | Tucson | Arizona |
| United States | Bayview Research Group | Valley Village | California |
| United States | Buynak Clinical Research, P.C. | Valparaiso | Indiana |
| United States | Renaissance Imaging Medical Associates, Inc | Van Nuys | California |
| United States | Arthritis, Rheumatic and Back Disease Associates, PA | Voorhees | New Jersey |
| United States | MedVadis Research Corporation | Watertown | Massachusetts |
| United States | ClinPoint Trials | Waxahachie | Texas |
| United States | Mercury Clinical Research | Webester | Texas |
| United States | Buhay & Maglunog MDS | West Covina | California |
| United States | Prohealth Advanced Imaging | West Hills | California |
| United States | Palm Beach Research Center | West Palm Beach | Florida |
| United States | Advanced Rx Clinical Research Group, Inc | Westminster | California |
| United States | The Center for Rheumatology and Bone Research | Wheaton | Maryland |
| United States | Medvin Clinical Research | Whittier | California |
| United States | Heartland Research Associates, LLC | Wichita | Kansas |
| United States | Professional Research Network of Kansas, LLC | Wichita | Kansas |
| United States | Clinics of North Texas | Wichita Falls | Texas |
| United States | Grayline Clinical Drug Trials | Wichita Falls | Texas |
| United States | Elite Clinical Trials | Wildomar | California |
| United States | Upstate Clinical Research Associates, LLC | Williamsville | New York |
| United States | The Center for Clinical Research | Winston-Salem | North Carolina |
| United States | North Georgia Clinical Research | Woodstock | Georgia |
| United States | North Georgia Internal Medicine | Woodstock | Georgia |
| United States | Clinical Research Center of Reading, LLC | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Brazil, Bulgaria, Colombia, Croatia, Japan, Korea, Republic of, Lithuania, Mexico, New Zealand, Peru, Philippines, Russian Federation, Serbia, Slovakia, Taiwan, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome | 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 | |
| Primary | Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome | 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 | |
| Primary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at 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 | |
| Primary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at 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 | |
| Primary | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at 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 | Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome | 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 | |
| Secondary | Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome | 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 | |
| Secondary | Percentage of Participants With Individual Adjudicated Joint Safety Outcome | 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 | |
| Secondary | Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome | 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 | |
| Secondary | Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | 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 | |
| Secondary | Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome | 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 | |
| Secondary | 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 | 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 | |
| Secondary | Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | Change From Baseline in WOMAC Pain Subscale at 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 | |
| Secondary | Change From Baseline in WOMAC Pain Subscale at 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 | |
| Secondary | Change From Baseline in WOMAC Physical Function Subscale at 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 | |
| Secondary | Change From Baseline in WOMAC Physical Function Subscale at 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 | |
| Secondary | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at 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 | |
| Secondary | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | Change From Baseline in Average Pain Score in the Index Joint at 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 | |
| Secondary | 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 | 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 | |
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at 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 | |
| Secondary | 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 | 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 | |
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at 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 | |
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 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 | |
| Secondary | 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 | 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 | |
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 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 | |
| Secondary | 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 | 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 | |
| Secondary | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at 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 | |
| Secondary | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at 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 | |
| Secondary | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain | 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 | |
| Secondary | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain | 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 | |
| Secondary | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain | 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 | |
| Secondary | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain | 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 | |
| Secondary | Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain | 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 | |
| Secondary | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | 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 | |
| Secondary | Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses | 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 | |
| Secondary | 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? | 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 | |
| Secondary | 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? | 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 | |
| Secondary | 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? | 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 | |
| Secondary | Number of Participants Who Withdrew Due to Lack of Efficacy | Number of participants who withdrew from treatment due to lack of efficacy have been reported here. | Baseline up to Week 56 | |
| Secondary | Time to Discontinuation Due to Lack of Efficacy | Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy. | Baseline up to Week 56 | |
| Secondary | Number of Participants Who Took Rescue Medication During 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 | |
| Secondary | Number of Participants Who Took Rescue Medication During 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 | |
| Secondary | Number of Days of Rescue Medication Used During 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 | |
| Secondary | Number of Days of Rescue Medication Used During 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 | |
| Secondary | Amount of Rescue Medication Used During 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 | |
| Secondary | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | 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 | |
| Secondary | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | 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 | |
| Secondary | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | 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 | |
| Secondary | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | 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 | |
| Secondary | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | 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 | |
| Secondary | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis | 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 | |
| Secondary | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | 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 | |
| Secondary | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | 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 | |
| Secondary | Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at 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 | |
| Secondary | Change From Baseline in Average Daily Minutes of Physical Activity at 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 | |
| Secondary | Change From Baseline in Average Daily Physical Activity Counts at 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 | |
| Secondary | Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at 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 | |
| Secondary | Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at 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 | |
| Secondary | Change From Baseline in Average Daily Step Count at 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 | |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 | |
| Secondary | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 | |
| Secondary | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN; Leukocytes <0.6*LLN, >1.5*ULN; Lymphocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN; Prothrombin time/Intl. normalized ratio>1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN; sodium<0.95*LLN,>1.05*ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN, >1.2*ULN; glucose<0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN, specific gravity<1.003, >1.030; pH<4.5, >8;Urine erythrocytes,Leukocytes>=20. | Baseline up to Week 80 | |
| Secondary | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; specific gravity<1.003, >1.030; Urine erythrocytes,Leukocytes>=20; Hyaline Casts>=1. | Baseline up to Week 80 | |
| Secondary | Change From Baseline in Blood Pressure (BP) at 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 | |
| Secondary | Change From Baseline in Heart Rate at 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 | |
| Secondary | Change From Baseline in Electrocardiogram (ECG) Parameters at 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 | |
| Secondary | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 | Heart rate was measured at sitting position. | Baseline, Weeks 56 and 80 | |
| Secondary | Number of Participants With Confirmed Orthostatic Hypotension | 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 | |
| Secondary | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at 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 | |
| Secondary | Change From Baseline in Neuropathy Impairment Score (NIS) at 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 | |
| Secondary | Number of Participants With Anti-Tanezumab Antibodies | 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 |
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