Clinical trial NCT02709486: Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee
Keywords: Osteoarthritis, pain, tanezumab.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2016-03-16
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a randomized, double blind, placebo controlled, parallel group multicenter Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for 24 weeks compared to placebo in subjects with osteoarthritis of the knee or hip. A total of approximately 810 subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (ie, 270/group). The randomization will be stratified by index joint (hip or knee), and most severe Kellgren-Lawrence grade (of any knee or hip joint) at study entry (grade 2, 3 or 4). Subjects will receive up to three SC doses of one of the following treatments at an 8-week interval between each injection:

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.

Eligibility criteria: 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 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 2, 4, 8, 12 and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32
timeFrame: Baseline, Week 32
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 2, 4, 8, 12 and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32
timeFrame: Baseline, Week 32
measure: Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 2, 4, 8, 12 and 16
measure: Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32
timeFrame: Baseline, Week 32
measure: Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
timeFrame: Weeks 2, 4, 8, 12, 16, 24 and 32
measure: Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response
timeFrame: Week 2, 4, 8, 12, 16, 24 and 32
measure: Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response
timeFrame: Weeks 2, 4, 8, 12, 16, 24 and 32
measure: Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
timeFrame: Weeks 2, 4, 8, 12, 16, 24 and 32
measure: Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24
measure: Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32
timeFrame: Baseline, Weeks 28 and 32
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16 and 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32
timeFrame: Baseline, Week 32
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16 and 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32
timeFrame: Baseline, Week 32
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, 16 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16 and 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32
timeFrame: Baseline, Week 32
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Weeks 2, 4, 8, 12, 16 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16 and 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32
timeFrame: Baseline, Week 32
measure: Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline
timeFrame: Baseline
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
timeFrame: Baseline, Weeks 8, 16 and 24
measure: European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study?
timeFrame: Weeks 16 and 24
measure: Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling?
timeFrame: Weeks 16 and 24
measure: Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
timeFrame: Weeks 16 and 24
measure: Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain?
timeFrame: Weeks 16 and 24
measure: Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
timeFrame: Baseline, Weeks 32 and 48
measure: Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
timeFrame: Baseline, Weeks 32 and 48
measure: Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
timeFrame: Baseline, Weeks 32 and 48
measure: Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
timeFrame: Baseline, Weeks 32 and 48
measure: Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis
timeFrame: Baseline, Weeks 32 and 48
measure: Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
timeFrame: Baseline, Weeks 32 and 48
measure: Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
timeFrame: Baseline, Weeks 32 and 48
measure: Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
timeFrame: Baseline, Weeks 32 and 48
measure: Number of Participants Who Withdrew Due to Lack of Efficacy
timeFrame: Baseline up to Week 24
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 24
measure: Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24
timeFrame: Weeks 2, 4, 8, 12, 16 and 24
measure: Number of Participants Who Took Rescue Medication During Week 32
timeFrame: Week 32
measure: Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24
timeFrame: Weeks 2, 4, 8, 12, 16 and 24
measure: Number of Days of Rescue Medication Used at Week 32
timeFrame: Week 32
measure: Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24
timeFrame: Weeks 2, 4, 8, 12, 16 and 24
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study
timeFrame: Baseline up to Week 48
measure: Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study
timeFrame: Baseline up to Week 48
measure: Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
timeFrame: Baseline up to Week 48
measure: Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
timeFrame: Baseline up to Week 48
measure: Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48
measure: Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48
timeFrame: Baseline, Weeks 2, 4, 8, 12,16, 24, 32 and 48
measure: Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48
timeFrame: Baseline, Weeks 24 and 48
measure: Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48
timeFrame: Baseline, Weeks 24 and 48
measure: Percentage of Participants With Adjudicated Joint Safety Outcomes
timeFrame: Baseline up to Week 48
measure: Percentage of Participants With Total Joint Replacements
timeFrame: Baseline up to Week 48
measure: Number of Participants With Confirmed Orthostatic Hypotension
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48
measure: Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48
measure: Number of Participants With Anti Tanezumab Antibodies
timeFrame: Baseline, Weeks 8,16, 24, 32 and 48
Other outcomes:
Locations:
city: Senftenberg
country: Austria
facility: Nuhr Medical Center
city: Wien
country: Austria
facility: Rheuma Zentrum Favoriten
city: Blagoevgrad
country: Bulgaria
facility: Medical Center BLAGOEVGRAD 2009, EOOD
city: Pleven
country: Bulgaria
facility: DCC St. Pantaleimon OOD
city: Plovdiv
country: Bulgaria
facility: Medical Center " Health for all" EOOD
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela
city: Ruse
country: Bulgaria
facility: "Medical Center Teodora" EOOD
city: Silistra
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment-Silistra AD
city: Smolyan
country: Bulgaria
facility: "Medical Center- Smolyan" OOD
city: Sofia
country: Bulgaria
facility: NMTH 'Tsar Boris III". Clinic of Internal Diseases
city: Sofia
country: Bulgaria
facility: Multiprofile hospital for active treatment - "Lyulin" EAD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center XIV- Sofia EOOD
city: Sofia
country: Bulgaria
facility: Medical Center-Avicena EOOD
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski - EAD
city: Sofia
country: Bulgaria
facility: UMHAT "Sofiamed" OOD, Block 2
city: Sofia
country: Bulgaria
facility: "Medical Center - Dr. Hayvazov" EOOD
city: Stara Zagora
country: Bulgaria
facility: UMHAT "Prof. Dr. Stoyan Kirkovich" AD
city: Vidin
country: Bulgaria
facility: Multiprofile Hospital for active treatment "SVETA PETKA" AD
city: Kuopio
country: Finland
facility: Dextra Oy/Pihlajalinna Ite Kuopio
city: Oulu
country: Finland
facility: Oulu Deaconess Institute
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Montpellier Cedex 5
country: France
facility: Unite Clinique Therapeutique des Maladies Osteoarticulaires
city: Orleans
country: France
facility: CHR Orleans La Source
city: Paris cedex 10
country: France
facility: Hopital Lariboisiere
city: Paris cedex 12
country: France
facility: Hopital Saint-Antoine
city: Paris cedex 14
country: France
facility: Hôpital Cochin
city: Paris cedex 14
country: France
facility: Hopital Cochin
city: Offenbach
country: Germany
facility: Praxis Dr. Kronung
state: Hesse
city: Aachen
country: Germany
facility: Rheumapraxis
city: Bad Doberan
country: Germany
facility: Rheumazentrum Prof. Dr. med Gunther Neeck
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik GmbH
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Frankfurt am Main
country: Germany
facility: CIRI GmbH
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Központi Korhaz Dr Rethy Pal Tagkorhaz, Reumatologia Szakrendeles
city: Budapest
country: Hungary
facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Kecskemét
country: Hungary
facility: Jutrix Kft
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly
city: Firenze
country: Italy
facility: Farmacia AOUC Settore Sperimentazione Farmaci
state: FI
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Unita Operativa di Medicina Generale e Reumatologia -
state: Milan
city: Bologna
country: Italy
facility: Azienda Ospedaliera-Universitaria S.Orsola-Malpighi
city: Bologna
country: Italy
facility: Farmacia Clinica Puggioli
city: Firenze
country: Italy
facility: AZ OSPEDALIERO - UNIVERSITARIA CAREGGI-SOD Reumatologia - Dip. Medicina Sperimentale e Clinica
city: Firenze
country: Italy
facility: Dipartmento di diagnostica per immagini
city: Novara
country: Italy
facility: AOU Maggiore della Carita di Novara - S.C. Medicina Fisica e Riabilitativa
city: Novara
country: Italy
facility: Dipartimento Immagini Radiologia
city: Novara
country: Italy
facility: Farmacia Ospedaliera
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria E Policlinico Umberto I
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese - UOC Reumatologia,
city: Siena
country: Italy
facility: U.O.C. Farmacia - Gestione medicinali per la sperimentazione clinica
city: Verona
country: Italy
facility: Ospedale Civile Maggiore Borgo Trento
city: Ichikawa
country: Japan
facility: Sato Orthopedic Clinic
state: Chiba
city: Kamagaya
country: Japan
facility: Kamagaya General Hospital
state: Chiba
city: Higashi-ku,Fukuoka
country: Japan
facility: Fukuoka Mirai Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Shinkokura Hospital
state: Fukuoka
city: Miyako-gun
country: Japan
facility: Obase Hospital
state: Fukuoka
city: Okawa
country: Japan
facility: Takagi Hospital
state: Fukuoka
city: Yamegun
country: Japan
facility: Himeno Hospital
state: Fukuoka
city: Chitose
country: Japan
facility: Takahashi Orthopedics Clinic
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Central General Hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Ohmura Orthopedic Hospital
state: Hokkaido
city: Obihiro
country: Japan
facility: Obihiro Orthopaedic Hospital
state: Hokkaido
city: Akashi
country: Japan
facility: Okubo Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe Kaisei Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe Konan Yamate clinic
state: Hyogo
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Medical Corporation Association Sankikai, Yokohama Shinmidori General Hospital
state: Kanagawa
city: Matsumoto
country: Japan
facility: Marunouchi Hospital
state: Nagano
city: Omura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Higashiosaka
country: Japan
facility: Sobajima Clinic/Orthopedics
state: Osaka
city: Kawachinagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu Medical Center
state: Shizuoka
city: Utsunomiya
country: Japan
facility: National Hospital Organization Utsunomiya national Hospital
state: Tochigi
city: Adachi-ku
country: Japan
facility: Sonodakai Joint Replacement Center Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Ohimachi Orthopaedic Clinic
state: Tokyo
city: Akita
country: Japan
facility: Akita City Hospital
city: Fukuoka
country: Japan
facility: Kyushu Central Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Clinic
city: Kyoto
country: Japan
facility: Jujo Takeda Rehabilitation Hospital
city: Osaka
country: Japan
facility: Nagayoshi General Hospital
city: Bialystok
country: Poland
facility: NZOZ OSTEO-MEDIC s.c. A. Racewicz, J. Supronik
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Społka Jawna
city: Elblag
country: Poland
facility: Centrum Kliniczno - Badawcze J. Brzezicki, B. Gornikiewicz - Brzezicka Lekarze Spolka Partnerska
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
city: Krakow
country: Poland
facility: Centrum Medyczne Pratia Krakow
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne S.C
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M Jasnorzewska
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Warszawa
country: Poland
facility: REUMATIKA - Centrum Reumatologii NZOZ
city: Ponte De Lima
country: Portugal
facility: Hospital Conde de Bertiandos
state: Viana DO Castelo
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental, E.P.E., Hospital Egas Moniz
city: Lisboa
country: Portugal
facility: Hospital Egas Moniz
city: Bucuresti
country: Romania
facility: SC Duo Medical SRL
state: Sector 1
city: Bucuresti
country: Romania
facility: Centrul Medical SANA S.R.L.
state: Sector 1
city: Bacau
country: Romania
facility: Spitalul Judetean de Urgenta Bacau
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Sf. Maria"
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Bratislava
country: Slovakia
facility: AB-BA ambulancia s.r.o.
city: Bratislava
country: Slovakia
facility: ROMJAN s.r.o.
city: Dolny Kubín
country: Slovakia
facility: Kompan, s.r.o
city: Kosice
country: Slovakia
facility: ALGMED s.r.o.
city: Nove Mesto nad Vahom
country: Slovakia
facility: Reum. hapi s.r.o.
city: Piestany
country: Slovakia
facility: Medipa s.r.o.
city: Pruske
country: Slovakia
facility: MUDr. Viliam Cibik, PhD, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: Reumex s.r.o
city: Santiago de Compostela
country: Spain
facility: Hospital La Esperanza
state: A Coruna
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli de Sabadell
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí de Sabadell
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: A Coruna
country: Spain
facility: Complejo Hospital Universitario A Coruna (CHUAC)
city: A Coruña
country: Spain
facility: Hospital La Esperanza
city: Alicante
country: Spain
facility: Instituto de Ciencias Medicas
city: Alicante
country: Spain
facility: Instituto de Ciencias Médicas
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital CIMA Sanitas
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia.
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Getafe, Madrid
country: Spain
facility: Hospital Universitario de Getafe
city: Guadalajara
country: Spain
facility: Hospital General Universitario de Guadalajara
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa Farmacia - Ensayos Clinicos
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz Servicio de Farmacia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga. Farmacia del Hospital Civil
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
city: Boras
country: Sweden
facility: Ladulaas Kliniska Studier
city: Gothenburg
country: Sweden
facility: CTC (Clinical Trial Center), Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: ProbarE i Lund AB
city: Malmo
country: Sweden
facility: PharmaSite
city: Orebro
country: Sweden
facility: Avdelningen for kliniska provningar, S-huset
city: Stockholm
country: Sweden
facility: ProbarE
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance, Fas 1
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance, KTA.
city: Penzance
country: United Kingdom
facility: The Alverton Practice
state: Cornwall
city: St. Austell
country: United Kingdom
facility: Brannel Surgery
state: Cornwall
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
state: Devon
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Midlothian
city: Bradford on Avon
country: United Kingdom
facility: Clinical Trials, Bradford on Avon Health Centre
city: Bradford on Avon
country: United Kingdom
facility: Health Centre, Bradford on Avon & Melksham Health Partnership
city: Headington, Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Nuffield Department of Orthopaedics
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.