Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.
NCT ID: NCT02709486
Last Updated: 2019-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
849 participants
INTERVENTIONAL
2016-03-02
2018-11-14
Brief Summary
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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.
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Detailed Description
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1. tanezumab 2.5 mg;
2. tanezumab 5 mg;
3. Placebo to match tanezumab. The study is designed with a total (post-randomization) duration of 48 weeks and will consist of three periods: Screening (up to 37 days), Double-blind Treatment (24 weeks) and Safety Follow-up (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting a minimum of 2 days for all prohibited pain medications), if required, and an Initial Pain Assessment Period (the 7 days prior to Randomization/Baseline).
Week 24 is the landmark analysis in this study. Subjects who do not complete the Double-blind Treatment period will enter and complete the 24-week Early-termination follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose
Investigational product
Tanezumab
2.5 mg
High dose
Investigational product
Tanezumab
5 mg
Placebo
Investigational product
Placebo
Placebo
Interventions
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Tanezumab
2.5 mg
Tanezumab
5 mg
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Nuhr Medical Center
Senftenberg, , Austria
Rheuma Zentrum Favoriten
Vienna, , Austria
Medical Center BLAGOEVGRAD 2009, EOOD
Blagoevgrad, , Bulgaria
DCC St. Pantaleimon OOD
Pleven, , Bulgaria
Medical Center " Health for all" EOOD
Plovdiv, , Bulgaria
UMHAT Kaspela
Plovdiv, , Bulgaria
"Medical Center Teodora" EOOD
Rousse, , Bulgaria
Multiprofile Hospital for Active Treatment-Silistra AD
Silistra, , Bulgaria
"Medical Center- Smolyan" OOD
Smolyan, , Bulgaria
NMTH 'Tsar Boris III". Clinic of Internal Diseases
Sofia, , Bulgaria
Multiprofile hospital for active treatment - "Lyulin" EAD
Sofia, , Bulgaria
Diagnostic Consultative Center XIV- Sofia EOOD
Sofia, , Bulgaria
Medical Center-Avicena EOOD
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski - EAD
Sofia, , Bulgaria
UMHAT "Sofiamed" OOD, Block 2
Sofia, , Bulgaria
"Medical Center - Dr. Hayvazov" EOOD
Sofia, , Bulgaria
UMHAT "Prof. Dr. Stoyan Kirkovich" AD
Stara Zagora, , Bulgaria
Multiprofile Hospital for active treatment "SVETA PETKA" AD
Vidin, , Bulgaria
Dextra Oy/Pihlajalinna Ite Kuopio
Kuopio, , Finland
Oulu Deaconess Institute
Oulu, , Finland
Hôpital Edouard Herriot
Lyon, , France
Unite Clinique Therapeutique des Maladies Osteoarticulaires
Montpellier, , France
CHR Orleans La Source
Orléans, , France
Hopital Lariboisiere
Paris, , France
Hopital Saint-Antoine
Paris, , France
Hôpital Cochin
Paris, , France
Hopital Cochin
Paris, , France
Praxis Dr. Kronung
Offenbach, Hesse, Germany
Rheumapraxis
Aachen, , Germany
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, , Germany
Kerckhoff Klinik GmbH
Bad Nauheim, , Germany
Charite Universitaetsmedizin Berlin
Berlin, , Germany
CIRI GmbH
Frankfurt am Main, , Germany
Bekes Megyei Központi Korhaz Dr Rethy Pal Tagkorhaz, Reumatologia Szakrendeles
Békéscsaba, , Hungary
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
Qualiclinic Kft.
Budapest, , Hungary
Jutrix Kft
Kecskemét, , Hungary
Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly
Szekszárd, , Hungary
Farmacia AOUC Settore Sperimentazione Farmaci
Florence, FI, Italy
Istituto Clinico Humanitas Unita Operativa di Medicina Generale e Reumatologia -
Rozzano, Milan, Italy
Azienda Ospedaliera-Universitaria S.Orsola-Malpighi
Bologna, , Italy
Farmacia Clinica Puggioli
Bologna, , Italy
AZ OSPEDALIERO - UNIVERSITARIA CAREGGI-SOD Reumatologia - Dip. Medicina Sperimentale e Clinica
Florence, , Italy
Dipartmento di diagnostica per immagini
Florence, , Italy
AOU Maggiore della Carita di Novara - S.C. Medicina Fisica e Riabilitativa
Novara, , Italy
Dipartimento Immagini Radiologia
Novara, , Italy
Farmacia Ospedaliera
Novara, , Italy
Azienda Ospedaliero-Universitaria E Policlinico Umberto I
Rome, , Italy
Azienda Ospedaliera Universitaria Senese - UOC Reumatologia,
Siena, , Italy
U.O.C. Farmacia - Gestione medicinali per la sperimentazione clinica
Siena, , Italy
Ospedale Civile Maggiore Borgo Trento
Verona, , Italy
Sato Orthopedic Clinic
Ichikawa, Chiba, Japan
Kamagaya General Hospital
Kamagaya, Chiba, Japan
Fukuoka Mirai Hospital
Higashi-ku,Fukuoka, Fukuoka, Japan
Shinkokura Hospital
Kitakyushu, Fukuoka, Japan
Obase Hospital
Miyako-gun, Fukuoka, Japan
Takagi Hospital
Ōkawa, Fukuoka, Japan
Himeno Hospital
Yamegun, Fukuoka, Japan
Takahashi Orthopedics Clinic
Chitose, Hokkaido, Japan
Hakodate Central General Hospital
Hakodate, Hokkaido, Japan
Hakodate Ohmura Orthopedic Hospital
Hakodate, Hokkaido, Japan
Obihiro Orthopaedic Hospital
Obihiro, Hokkaido, Japan
Okubo Hospital
Akashi, Hyōgo, Japan
Kobe Kaisei Hospital
Kobe, Hyōgo, Japan
Kobe Konan Yamate clinic
Kobe, Hyōgo, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
Medical Corporation Association Sankikai, Yokohama Shinmidori General Hospital
Yokohama, Kanagawa, Japan
Marunouchi Hospital
Matsumoto, Nagano, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan
Sobajima Clinic/Orthopedics
Higashiosaka, Osaka, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan
Hamamatsu Medical Center
Hamamatsu, Shizuoka, Japan
National Hospital Organization Utsunomiya national Hospital
Utsunomiya, Tochigi, Japan
Sonodakai Joint Replacement Center Hospital
Adachi-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan
Ohimachi Orthopaedic Clinic
Shinagawa-ku, Tokyo, Japan
Akita City Hospital
Akita, , Japan
Kyushu Central Hospital
Fukuoka, , Japan
Hiroshima Clinic
Hiroshima, , Japan
Jujo Takeda Rehabilitation Hospital
Kyoto, , Japan
Nagayoshi General Hospital
Osaka, , Japan
NZOZ OSTEO-MEDIC s.c. A. Racewicz, J. Supronik
Bialystok, , Poland
ClinicMed Daniluk, Nowak Społka Jawna
Bialystok, , Poland
Centrum Kliniczno - Badawcze J. Brzezicki, B. Gornikiewicz - Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Centrum Medyczne Pratia Gdynia
Gdynia, , Poland
Centrum Medyczne Pratia Krakow
Krakow, , Poland
Malopolskie Centrum Medyczne S.C
Krakow, , Poland
Centrum Terapii Wspolczesnej J.M Jasnorzewska
Lodz, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
REUMATIKA - Centrum Reumatologii NZOZ
Warsaw, , Poland
Hospital Conde de Bertiandos
Ponte de Lima, Viana do Castelo District, Portugal
Centro Hospitalar Lisboa Ocidental, E.P.E., Hospital Egas Moniz
Lisbon, , Portugal
Hospital Egas Moniz
Lisbon, , Portugal
SC Duo Medical SRL
Bucharest, Sector 1, Romania
Centrul Medical SANA S.R.L.
Bucharest, Sector 1, Romania
Spitalul Judetean de Urgenta Bacau
Bacau, , Romania
Spitalul Clinic "Sf. Maria"
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
Constanța, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, , Romania
AB-BA ambulancia s.r.o.
Bratislava, , Slovakia
ROMJAN s.r.o.
Bratislava, , Slovakia
Kompan, s.r.o
Dolny Kubín, , Slovakia
ALGMED s.r.o.
Košice, , Slovakia
Reum. hapi s.r.o.
Nové Mesto nad Váhom, , Slovakia
Medipa s.r.o.
Piešťany, , Slovakia
MUDr. Viliam Cibik, PhD, s.r.o.
Pruské, , Slovakia
Reumex s.r.o
Rimavská Sobota, , Slovakia
Hospital La Esperanza
Santiago de Compostela, A Coruna, Spain
Corporacio Sanitaria Parc Tauli de Sabadell
Sabadell, Barcelona, Spain
Corporació Sanitaria Parc Taulí de Sabadell
Sabadell, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Complejo Hospital Universitario A Coruna (CHUAC)
A Coruña, , Spain
Hospital La Esperanza
A Coruña, , Spain
Instituto de Ciencias Medicas
Alicante, , Spain
Instituto de Ciencias Médicas
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital CIMA Sanitas
Barcelona, , Spain
Hospital Universitario Reina Sofia.
Córdoba, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario de Getafe
Getafe, Madrid, , Spain
Hospital General Universitario de Guadalajara
Guadalajara, , Spain
Hospital Universitario La Princesa Farmacia - Ensayos Clinicos
Madrid, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario La Paz Servicio de Farmacia
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Malaga. Farmacia del Hospital Civil
Málaga, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Infanta Luisa
Seville, , Spain
Ladulaas Kliniska Studier
Borås, , Sweden
CTC (Clinical Trial Center), Sahlgrenska University Hospital
Gothenburg, , Sweden
ProbarE i Lund AB
Lund, , Sweden
PharmaSite
Malmo, , Sweden
Avdelningen for kliniska provningar, S-huset
Örebro, , Sweden
ProbarE
Stockholm, , Sweden
Karolinska Trial Alliance, Fas 1
Stockholm, , Sweden
Karolinska Trial Alliance, KTA.
Stockholm, , Sweden
The Alverton Practice
Penzance, Cornwall, United Kingdom
Brannel Surgery
St Austell, Cornwall, United Kingdom
Knowle House Surgery
Plymouth, Devon, United Kingdom
Western General Hospital
Edinburgh, Midlothian, United Kingdom
Clinical Trials, Bradford on Avon Health Centre
Bradford-on-Avon, , United Kingdom
Health Centre, Bradford on Avon & Melksham Health Partnership
Bradford-on-Avon, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Headington, Oxford, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, , United Kingdom
Nuffield Department of Orthopaedics
Oxford, , United Kingdom
Countries
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References
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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.
Guermazi 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.
Carrino 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.
Shoji 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.
Brown 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.
Colloca 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.
Hunter 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.
Atkinson 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.
Mease 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.
Schnitzer 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.
Conaghan 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.
Conaghan 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.
Berenbaum 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.
Berenbaum 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.
Berenbaum 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.
Berenbaum 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
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Other Identifiers
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2013-004508-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OA 6-MONTH EU STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
A4091057
Identifier Type: -
Identifier Source: org_study_id
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