Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
3 other identifiers
interventional
849
15 countries
148
Brief Summary
Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions. The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2016
Typical duration for phase_3
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2016
CompletedStudy Start
First participant enrolled
March 2, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2018
CompletedResults Posted
Study results publicly available
June 26, 2019
CompletedJune 26, 2019
June 1, 2019
2.3 years
February 26, 2016
June 6, 2019
June 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (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 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 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
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 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 24
Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24
PGA of OA was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) 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 worsening of condition.
Baseline, Week 24
Secondary Outcomes (59)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16
Baseline, Weeks 2, 4, 8, 12 and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32
Baseline, Week 32
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16
Baseline, Weeks 2, 4, 8, 12 and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32
Baseline, Week 32
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16
Baseline, Weeks 2, 4, 8, 12 and 16
- +54 more secondary outcomes
Study Arms (3)
Low dose
EXPERIMENTALInvestigational product
High dose
EXPERIMENTALInvestigational product
Placebo
PLACEBO COMPARATORInvestigational product
Interventions
Eligibility Criteria
You may qualify if:
- A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence x-ray Grade of at least 2 as diagnosed by the Central Reader
- A history of insufficient pain relief from acetaminophen along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking NSAIDs, and tramadol or opioid treatments.
- WOMAC Pain subscale score of at least 5 in the index hip or knee 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.
You may not qualify if:
- Subjects exceeding protocol defined BMI or body weight limits.
- History of other diseases specified in the protocol (e.g. 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 (e.g. fibromyalgia, 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.
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Eli Lilly and Companycollaborator
Study Sites (148)
Nuhr Medical Center
Senftenberg, 3541, Austria
Rheuma Zentrum Favoriten
Vienna, 1100, Austria
Medical Center BLAGOEVGRAD 2009, EOOD
Blagoevgrad, 2700, Bulgaria
DCC St. Pantaleimon OOD
Pleven, 5800, Bulgaria
Medical Center " Health for all" EOOD
Plovdiv, 4000, Bulgaria
UMHAT Kaspela
Plovdiv, 4002, Bulgaria
"Medical Center Teodora" EOOD
Rousse, 7012, Bulgaria
Multiprofile Hospital for Active Treatment-Silistra AD
Silistra, 7500, Bulgaria
"Medical Center- Smolyan" OOD
Smolyan, 4700, Bulgaria
NMTH 'Tsar Boris III". Clinic of Internal Diseases
Sofia, 1233, Bulgaria
Multiprofile hospital for active treatment - "Lyulin" EAD
Sofia, 1336, Bulgaria
Diagnostic Consultative Center XIV- Sofia EOOD
Sofia, 1408, Bulgaria
Medical Center-Avicena EOOD
Sofia, 1408, Bulgaria
UMHAT Sveti Ivan Rilski - EAD
Sofia, 1612, Bulgaria
UMHAT "Sofiamed" OOD, Block 2
Sofia, 1750, Bulgaria
"Medical Center - Dr. Hayvazov" EOOD
Sofia, 1784, Bulgaria
UMHAT "Prof. Dr. Stoyan Kirkovich" AD
Stara Zagora, 6000, Bulgaria
Multiprofile Hospital for active treatment "SVETA PETKA" AD
Vidin, 3700, Bulgaria
Dextra Oy/Pihlajalinna Ite Kuopio
Kuopio, 70100, Finland
Oulu Deaconess Institute
Oulu, 90100, Finland
Hôpital Edouard Herriot
Lyon, 69003, France
Unite Clinique Therapeutique des Maladies Osteoarticulaires
Montpellier, 34295, France
CHR Orleans La Source
Orléans, 45067, France
Hopital Lariboisiere
Paris, 75475, France
Hopital Saint-Antoine
Paris, 75571, France
Hôpital Cochin
Paris, 75659, France
Hopital Cochin
Paris, 75679, France
Praxis Dr. Kronung
Offenbach, Hesse, 63073, Germany
Rheumapraxis
Aachen, 52064, Germany
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, 18209, Germany
Kerckhoff Klinik GmbH
Bad Nauheim, 61231, Germany
Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
CIRI GmbH
Frankfurt am Main, 60590, Germany
Bekes Megyei Központi Korhaz Dr Rethy Pal Tagkorhaz, Reumatologia Szakrendeles
Békéscsaba, 5600, Hungary
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
Budapest, 1033, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Qualiclinic Kft.
Budapest, 1036, Hungary
Jutrix Kft
Kecskemét, 6000, Hungary
Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly
Szekszárd, 7100, Hungary
Farmacia AOUC Settore Sperimentazione Farmaci
Florence, FI, 50134, Italy
Istituto Clinico Humanitas Unita Operativa di Medicina Generale e Reumatologia -
Rozzano, Milan, 20089, Italy
Azienda Ospedaliera-Universitaria S.Orsola-Malpighi
Bologna, 40138, Italy
Farmacia Clinica Puggioli
Bologna, 40138, Italy
AZ OSPEDALIERO - UNIVERSITARIA CAREGGI-SOD Reumatologia - Dip. Medicina Sperimentale e Clinica
Florence, 50134, Italy
Dipartmento di diagnostica per immagini
Florence, 50134, Italy
AOU Maggiore della Carita di Novara - S.C. Medicina Fisica e Riabilitativa
Novara, 28100, Italy
Dipartimento Immagini Radiologia
Novara, 28100, Italy
Farmacia Ospedaliera
Novara, 28100, Italy
Azienda Ospedaliero-Universitaria E Policlinico Umberto I
Rome, 00161, Italy
Azienda Ospedaliera Universitaria Senese - UOC Reumatologia,
Siena, 53100, Italy
U.O.C. Farmacia - Gestione medicinali per la sperimentazione clinica
Siena, 53100, Italy
Ospedale Civile Maggiore Borgo Trento
Verona, 37126, Italy
Sato Orthopedic Clinic
Ichikawa, Chiba, 272-0021, Japan
Kamagaya General Hospital
Kamagaya, Chiba, 273-0121, Japan
Fukuoka Mirai Hospital
Higashi-ku,Fukuoka, Fukuoka, 813-0017, Japan
Shinkokura Hospital
Kitakyushu, Fukuoka, 803-8505, Japan
Obase Hospital
Miyako-gun, Fukuoka, 800-0344, Japan
Takagi Hospital
Ōkawa, Fukuoka, 831-0016, Japan
Himeno Hospital
Yamegun, Fukuoka, 834-0115, Japan
Takahashi Orthopedics Clinic
Chitose, Hokkaido, 066-0062, Japan
Hakodate Central General Hospital
Hakodate, Hokkaido, 040-8585, Japan
Hakodate Ohmura Orthopedic Hospital
Hakodate, Hokkaido, 041-0802, Japan
Obihiro Orthopaedic Hospital
Obihiro, Hokkaido, 080-0802, Japan
Okubo Hospital
Akashi, Hyōgo, 674-0051, Japan
Kobe Kaisei Hospital
Kobe, Hyōgo, 657-0068, Japan
Kobe Konan Yamate clinic
Kobe, Hyōgo, 658-0011, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, 252-0392, Japan
Medical Corporation Association Sankikai, Yokohama Shinmidori General Hospital
Yokohama, Kanagawa, 226-0025, Japan
Marunouchi Hospital
Matsumoto, Nagano, 390-8601, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, 856-8562, Japan
Sobajima Clinic/Orthopedics
Higashiosaka, Osaka, 577-0011, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, 586-8521, Japan
Hamamatsu Medical Center
Hamamatsu, Shizuoka, 432-8580, Japan
National Hospital Organization Utsunomiya national Hospital
Utsunomiya, Tochigi, 329-1193, Japan
Sonodakai Joint Replacement Center Hospital
Adachi-ku, Tokyo, 121-0064, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
Ohimachi Orthopaedic Clinic
Shinagawa-ku, Tokyo, 140-0014, Japan
Akita City Hospital
Akita, 010-0933, Japan
Kyushu Central Hospital
Fukuoka, 815-8588, Japan
Hiroshima Clinic
Hiroshima, 733-0032, Japan
Jujo Takeda Rehabilitation Hospital
Kyoto, 601-8325, Japan
Nagayoshi General Hospital
Osaka, 547-0016, Japan
NZOZ OSTEO-MEDIC s.c. A. Racewicz, J. Supronik
Bialystok, 15-351, Poland
ClinicMed Daniluk, Nowak Społka Jawna
Bialystok, 15-879, Poland
Centrum Kliniczno - Badawcze J. Brzezicki, B. Gornikiewicz - Brzezicka Lekarze Spolka Partnerska
Elblag, 82-300, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338, Poland
Centrum Medyczne Pratia Krakow
Krakow, 30-002, Poland
Malopolskie Centrum Medyczne S.C
Krakow, 30-510, Poland
Centrum Terapii Wspolczesnej J.M Jasnorzewska
Lodz, 90-242, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
REUMATIKA - Centrum Reumatologii NZOZ
Warsaw, 02-691, Poland
Hospital Conde de Bertiandos
Ponte de Lima, Viana do Castelo District, 4990-041, Portugal
Centro Hospitalar Lisboa Ocidental, E.P.E., Hospital Egas Moniz
Lisbon, 1349-019, Portugal
Hospital Egas Moniz
Lisbon, 1349-019, Portugal
SC Duo Medical SRL
Bucharest, Sector 1, 010584, Romania
Centrul Medical SANA S.R.L.
Bucharest, Sector 1, 011025, Romania
Spitalul Judetean de Urgenta Bacau
Bacau, 600114, Romania
Spitalul Clinic "Sf. Maria"
Bucharest, 011172, Romania
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
Constanța, 900591, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245, Romania
AB-BA ambulancia s.r.o.
Bratislava, 851 07, Slovakia
ROMJAN s.r.o.
Bratislava, 85101, Slovakia
Kompan, s.r.o
Dolny Kubín, 02601, Slovakia
ALGMED s.r.o.
Košice, 040 01, Slovakia
Reum. hapi s.r.o.
Nové Mesto nad Váhom, 915 01, Slovakia
Medipa s.r.o.
Piešťany, 921 01, Slovakia
MUDr. Viliam Cibik, PhD, s.r.o.
Pruské, 018 52, Slovakia
Reumex s.r.o
Rimavská Sobota, 979 01, Slovakia
Hospital La Esperanza
Santiago de Compostela, A Coruna, 15705, Spain
Corporacio Sanitaria Parc Tauli de Sabadell
Sabadell, Barcelona, 08208, Spain
Corporació Sanitaria Parc Taulí de Sabadell
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario de Getafe
Getafe, Madrid, 28905, Spain
Complejo Hospital Universitario A Coruna (CHUAC)
A Coruña, 15006, Spain
Hospital La Esperanza
A Coruña, 15705, Spain
Instituto de Ciencias Medicas
Alicante, 03004, Spain
Instituto de Ciencias Médicas
Alicante, 03004, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital CIMA Sanitas
Barcelona, 08034, Spain
Hospital Universitario Reina Sofia.
Córdoba, 14004, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario de Getafe
Getafe, Madrid, 28905, Spain
Hospital General Universitario de Guadalajara
Guadalajara, 19002, Spain
Hospital Universitario La Princesa Farmacia - Ensayos Clinicos
Madrid, 28006, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz Servicio de Farmacia
Madrid, 28046, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Regional Universitario de Malaga. Farmacia del Hospital Civil
Málaga, 29009, Spain
Hospital Regional Universitario de Malaga
Málaga, 29009, Spain
Hospital Infanta Luisa
Seville, 41010, Spain
Ladulaas Kliniska Studier
Borås, SE-50630, Sweden
CTC (Clinical Trial Center), Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
ProbarE i Lund AB
Lund, 222 22, Sweden
PharmaSite
Malmo, 211 52, Sweden
Avdelningen for kliniska provningar, S-huset
Örebro, 703 62, Sweden
ProbarE
Stockholm, 11137, Sweden
Karolinska Trial Alliance, Fas 1
Stockholm, 141 86, Sweden
Karolinska Trial Alliance, KTA.
Stockholm, 141 86, Sweden
The Alverton Practice
Penzance, Cornwall, TR18 4JH, United Kingdom
Brannel Surgery
St Austell, Cornwall, PL26 7RL, United Kingdom
Knowle House Surgery
Plymouth, Devon, PL5 3JB, United Kingdom
Western General Hospital
Edinburgh, Midlothian, EH4 2XU, United Kingdom
Clinical Trials, Bradford on Avon Health Centre
Bradford-on-Avon, BA13 1DQ, United Kingdom
Health Centre, Bradford on Avon & Melksham Health Partnership
Bradford-on-Avon, BA15 1DQ, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Headington, Oxford, OX3 7LD, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, NE29 8NH, United Kingdom
Nuffield Department of Orthopaedics
Oxford, OX3 7HE, United Kingdom
Related Publications (16)
Schnitzer TJ, Conaghan PG, Berenbaum F, Abraham L, Cappelleri JC, Bushmakin AG, Viktrup L, Yang R, Brown MT. Effect size varies based on calculation method and may affect interpretation of treatment effect: an illustration using randomised clinical trials in osteoarthritis. Adv Rheumatol. 2024 Apr 22;64(1):31. doi: 10.1186/s42358-024-00358-y.
PMID: 38650049DERIVEDGuermazi A, Roemer FW, Kompel AJ, Diaz LE, Crema MD, Brown MT, Hickman A, Pixton GC, Viktrup L, Fountaine RJ, Burr A, Sherlock SP, West CR. Inter-Reader Consistency and Exclusionary Findings During Radiographic Screening for Phase 3 Trials of Tanezumab in Patients With Osteoarthritis. Osteoarthr Imaging. 2022 Sep-Dec;2(3-4):100082. doi: 10.1016/j.ostima.2022.100082. Epub 2022 Nov 15.
PMID: 38343426DERIVEDCarrino JA, McAlindon TE, Schnitzer TJ, Guermazi A, Hochberg MC, Conaghan PG, Brown MT, Burr A, Fountaine RJ, Pixton GC, Viktrup L, Verburg KM, West CR. Characterization of adverse joint outcomes in patients with osteoarthritis treated with subcutaneous tanezumab. Osteoarthritis Cartilage. 2023 Dec;31(12):1612-1626. doi: 10.1016/j.joca.2023.08.010. Epub 2023 Aug 29.
PMID: 37652258DERIVEDShoji S, Suzuki A, Nouri P, Cai CH, Gaitonde P, Marshall S. Prediction of relative change in free nerve growth factor following subcutaneous administration of tanezumab, a novel monoclonal antibody to nerve growth factor. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1358-1370. doi: 10.1002/psp4.13015. Epub 2023 Jul 31.
PMID: 37470295DERIVEDBrown MT, Cornblath DR, Koltzenburg M, Gorson KC, Hickman A, Pixton GC, Gaitonde P, Viktrup L, West CR. Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis. Clin Drug Investig. 2023 Jul;43(7):551-563. doi: 10.1007/s40261-023-01286-3. Epub 2023 Jul 18.
PMID: 37460782DERIVEDColloca L, Dworkin RH, Farrar JT, Tive L, Yang J, Viktrup L, Dasic G, West CR, Whalen E, Brown MT, Gilbert SA, Verburg KM. Predicting Treatment Responses in Patients With Osteoarthritis: Results From Two Phase III Tanezumab Randomized Clinical Trials. Clin Pharmacol Ther. 2023 Apr;113(4):878-886. doi: 10.1002/cpt.2842. Epub 2023 Jan 31.
PMID: 36621827DERIVEDHunter DJ, Schnitzer TJ, Hall J, Semel D, Davignon I, Cappelleri JC, Bushmakin AG, Abraham L. Time to first and sustained improvement in WOMAC domains among patients with osteoarthritis receiving tanezumab. Osteoarthr Cartil Open. 2022 Jul 2;4(3):100294. doi: 10.1016/j.ocarto.2022.100294. eCollection 2022 Sep.
PMID: 36474952DERIVEDAtkinson J, Edwards RA, Bonfanti G, Barroso J, Schnitzer TJ. A Two-Step, Trajectory-Focused, Analytics Approach to Attempt Prediction of Analgesic Response in Patients with Moderate-to-Severe Osteoarthritis. Adv Ther. 2023 Jan;40(1):252-264. doi: 10.1007/s12325-022-02336-6. Epub 2022 Oct 27.
PMID: 36301512DERIVEDMease P, Kuritzky L, Wright WL, Mallick-Searle T, Fountaine R, Yang R, Sadrarhami M, Faison W, Johnston E, Viktrup L. Efficacy and safety of tanezumab, NSAIDs, and placebo in patients with moderate to severe hip or knee osteoarthritis and a history of depression, anxiety, or insomnia: post-hoc analysis of phase 3 trials. Curr Med Res Opin. 2022 Nov;38(11):1909-1922. doi: 10.1080/03007995.2022.2113689. Epub 2022 Aug 28.
PMID: 35980115DERIVEDSchnitzer TJ, Bonfanti G, Atkinson J, Donevan S, Viktrup L, Barroso J, Whalen E, Edwards RA. Characterizing 16-Week Responder Profiles Using Group-Based Trajectory Modeling in Over 4300 Clinical Trial Participants Receiving Pharmaceutical Treatment for Moderate to Severe Osteoarthritis. Adv Ther. 2022 Oct;39(10):4742-4756. doi: 10.1007/s12325-022-02290-3. Epub 2022 Aug 12.
PMID: 35960482DERIVEDConaghan PG, Dworkin RH, Schnitzer TJ, Berenbaum F, Bushmakin AG, Cappelleri JC, Viktrup L, Abraham L. WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. J Rheumatol. 2022 Jun;49(6):615-621. doi: 10.3899/jrheum.210543. Epub 2022 Mar 1.
PMID: 35232805DERIVEDConaghan PG, Abraham L, Viktrup L, Cislo P. Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis. BMC Musculoskelet Disord. 2022 Feb 1;23(1):106. doi: 10.1186/s12891-022-05029-x.
PMID: 35105318DERIVEDBerenbaum F, Schnitzer T, Kivitz A, Viktrup L, Johnston E, Yang R, Whalen E, Tive L, Semel D. Gender, age, disease severity, body mass index and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo-controlled trials. Int J Clin Pract. 2021 Dec;75(12):e14975. doi: 10.1111/ijcp.14975. Epub 2021 Oct 21.
PMID: 34626502DERIVEDBerenbaum F, Schnitzer TJ, Kivitz AJ, Viktrup L, Hickman A, Pixton G, Brown MT, Davignon I, West CR. General Safety and Tolerability of Subcutaneous Tanezumab for Osteoarthritis: A Pooled Analysis of Three Randomized, Placebo-Controlled Trials. Arthritis Care Res (Hoboken). 2022 Jun;74(6):918-928. doi: 10.1002/acr.24637. Epub 2022 Mar 25.
PMID: 33973384DERIVEDBerenbaum F, Langford R, Perrot S, Miki K, Blanco FJ, Yamabe T, Isogawa N, Junor R, Carey W, Viktrup L, West CR, Brown MT, Verburg KM. Subcutaneous tanezumab for osteoarthritis: Is the early improvement in pain and function meaningful and sustained? Eur J Pain. 2021 Aug;25(7):1525-1539. doi: 10.1002/ejp.1764. Epub 2021 May 3.
PMID: 33728717DERIVEDBerenbaum F, Blanco FJ, Guermazi A, Miki K, Yamabe T, Viktrup L, Junor R, Carey W, Brown MT, West CR, Verburg KM. Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period. Ann Rheum Dis. 2020 Jun;79(6):800-810. doi: 10.1136/annrheumdis-2019-216296. Epub 2020 Mar 31.
PMID: 32234715DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2016
First Posted
March 16, 2016
Study Start
March 2, 2016
Primary Completion
June 8, 2018
Study Completion
November 14, 2018
Last Updated
June 26, 2019
Results First Posted
June 26, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.