Clinical trial NCT00809354: Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
Official title: A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF THE LONG-TERM ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ALONE OR IN COMBINATION WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) VERSUS NSAIDS ALONE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Arthritis
Keywords: monoclonal antibody
nerve growth factor (NGF)
anti-NGF
tanezumab
PF-04383119
RN624
osteoarthritis (OA)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 2720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.

Detailed description: This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.
* Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
* Pain level and function levels as required by the protocol at Screening and Baseline.
* Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol.
* Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

* Pregnant women.
* BMI greater than 39.
* Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA.
* Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening.
* Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
* History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
* At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women).
* Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
* Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.

Primary outcomes:
measure: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 24
measure: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
measure: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 24
measure: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56
measure: Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 24
measure: Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
measure: Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)
timeFrame: Weeks 2, 4, 8, 12, 16, and 24
measure: Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
measure: Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
measure: Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
measure: Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 16
measure: Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Weeks 2, 4, 8, 12, 16, and 24
measure: Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF)
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
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 Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
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 Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
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: Baseline Observation Carried Forward (BOCF)
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 Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
measure: 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, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
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 Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 12 and 24
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 12, 24, 40, and 56
measure: Number of Participants Who Had Discontinued Study Due to Lack of Efficacy
timeFrame: Baseline up to Week 56
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 56
measure: Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 24
measure: Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 24 and 56
measure: Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 24
measure: Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 24 and 56
measure: Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF
timeFrame: Baseline, Weeks 24 and 56
measure: Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 24, and 56
measure: Percentage of Participants Who Used Rescue Medication: Observed Data
timeFrame: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56
measure: Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)
timeFrame: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56
measure: Amount of Rescue Medication Used
timeFrame: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56
measure: Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56
timeFrame: Baseline, Week 56
measure: Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56
timeFrame: Baseline, Week 56
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 64
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
measure: Plasma Trough (Pre-dose) Concentration of Tanezumab
timeFrame: Predose on Day 1, Weeks 16, 24, 40, and 56
measure: Number of Participants With Intravenous (IV) Doses of Study Medication
timeFrame: Baseline up to Week 48
Other outcomes:
measure: Number of Participants With Anti-Drug Antibody (ADA) Response
timeFrame: Baseline, Weeks 16, 40, 24, and 56
measure: Number of Participants With Positive Urine or Serum Pregnancy Test
timeFrame: Baseline up to Week 56
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates, P.C.
state: Alabama
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Birmingham
country: United States
facility: Alliance Clinical Research
state: Alabama
city: Birmingham
country: United States
facility: Shades Mountain Imaging
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama, PC
state: Alabama
city: Huntsville
country: United States
facility: Saadat Ansari, MD Office
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Montgomery
country: United States
facility: Office of Vaughn H. Mancha, Jr., MD
state: Alabama
city: Chandler
country: United States
facility: Radiant Research - Phoenix Southeast
state: Arizona
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Green Valley
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Lake Havasu City
country: United States
facility: Midwest Internal Medicine, PLLC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Mesa
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Paradise Valley
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Sierra Vista
country: United States
facility: Cochise Clinical Research
state: Arizona
city: Tempe
country: United States
facility: Premiere Phamaceutical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Radiant Research
state: Arizona
city: Tucson
country: United States
facility: Arizona Research Associates
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical and Research Center
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Diagnostic Clinic, PA
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Family Practice Clinic
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Anaheim
country: United States
facility: Orange County Clinical Trials, Inc.
state: California
city: Carmichael
country: United States
facility: Med Center
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Fair Oaks
country: United States
facility: Med Investigations, Inc.
state: California
city: La Mesa
country: United States
facility: Triwest Research
state: California
city: Lakewood
country: United States
facility: Lakewood Orthopedic Medical & Surgical Group
state: California
city: Lakewood
country: United States
facility: Premier Clinical Research LLC.
state: California
city: Long Beach
country: United States
facility: Prohealth Partners
state: California
city: Los Angeles
country: United States
facility: Peak Health Medical Group, Inc.
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oceanside
country: United States
facility: eStudySite
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group Inc., Desert Oasis Healthcare
state: California
city: Rancho Mirage
country: United States
facility: Advances in Medicine
state: California
city: Sacramento
country: United States
facility: Mercy Imaging Center
state: California
city: Sacramento
country: United States
facility: Northern Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: San Jose
country: United States
facility: eStudySite
state: California
city: Santa Ana
country: United States
facility: Trinity Clinical Trials
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Stockton
country: United States
facility: St. Joseph Medical Associates
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Center
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Family Practice
state: Colorado
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Englewood
country: United States
facility: Colorado Arthritis Center, PC
state: Colorado
city: Bridgeport
country: United States
facility: Joao MA Nascimento, MD
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Lewes
country: United States
facility: Rheumatology Consultants of Delaware/Delaware Arthritis
state: Delaware
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Aventura
country: United States
facility: International Physicans Research
state: Florida
city: Aventura
country: United States
facility: Surgery Center of Aventura
state: Florida
city: Bradenton
country: United States
facility: HeartCare
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Cutler Bay
country: United States
facility: Homestead Clinical Research Group, P.A.
state: Florida
city: Daytona Beach
country: United States
facility: Covance CRU, Inc.
state: Florida
city: Dunedin
country: United States
facility: Robert W. Levin MD
state: Florida
city: Fort Myers
country: United States
facility: Internal Medicine Associates
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates, Clinical Study Center
state: Florida
city: Hialeah
country: United States
facility: Research Consultants Group
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lake Mary
country: United States
facility: Florida Arthritis
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Community Research Foundation
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Naples
country: United States
facility: Jeffrey Alper MD Research
state: Florida
city: Ocala
country: United States
facility: American Family Medicine
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Opa-locka
country: United States
facility: Sunshine Research Center
state: Florida
city: Orlando
country: United States
facility: Arthritis Associates
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Research of Florida, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research
state: Florida
city: Pemkbroke Pines
country: United States
facility: Pembroke Clinical Trials
state: Florida
city: Pinellas Park
country: United States
facility: Advent Clinical Research Center Inc
state: Florida
city: Pinellas Park
country: United States
facility: Advent Clinical Research Centers
state: Florida
city: Plantation
country: United States
facility: Berma Research Group
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Dale G. Bramlet, MD, P.L.
state: Florida
city: Sarasota
country: United States
facility: HeartCare Research
state: Florida
city: Sarasota
country: United States
facility: Kennedy-White Orthopaedic Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Center for Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: Sarasota
country: United States
facility: The Arthritis Specialty Centre
state: Florida
city: Tampa
country: United States
facility: Soutwest Florida Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, PA
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Reseach, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Laureate Clinical Research Group
state: Georgia
city: Roswell
country: United States
facility: ACCR/Internal Medicine
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Meridian
country: United States
facility: Idaho Arthritis & Osteoporosis Center, PC
state: Idaho
city: Nampa
country: United States
facility: Saltzer Medical Group PA
state: Idaho
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Rockford
country: United States
facility: Rockford Orthopedic Associates
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinical Research Department
state: Illinois
city: Vernon Hills
country: United States
facility: Deerbrook Medical Associates
state: Illinois
city: Avon
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc
state: Iowa
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Elizabethtown
country: United States
facility: Center for Arthritis and Osteoporosis
state: Kentucky
city: Lexington
country: United States
facility: Pain Treatment Center of the Bluegrass
state: Kentucky
city: Lexington
country: United States
facility: Pasadena Pharmacy
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Madisonville
country: United States
facility: Multicare Specialists
state: Kentucky
city: Baton Rouge
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: The Bone and Joint Clinic
state: Louisiana
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Brockton
country: United States
facility: Beacon Clinical Research
state: Massachusetts
city: Pittsfield
country: United States
facility: Berkshire Rheumatology
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Rheumatology PC
state: Michigan
city: Lansing
country: United States
facility: Justus J Fiechtner, MD
state: Michigan
city: Lansing
country: United States
facility: PCM Medical Services
state: Michigan
city: Traverse City
country: United States
facility: Medical Research Associates
state: Michigan
city: Biloxi
country: United States
facility: The Center for Clinical Trials
state: Mississippi
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Picayune
country: United States
facility: Highland Community Hospital
state: Mississippi
city: Picayune
country: United States
facility: Mississippi Medical Research
state: Mississippi
city: Florissant
country: United States
facility: No. County Internal Medicine & Rheumatology
state: Missouri
city: Kansas City
country: United States
facility: Dynamic Clinical Research, Inc.
state: Missouri
city: Kansas City
country: United States
facility: Joan Prouty Moore
state: Missouri
city: Kansas City
country: United States
facility: Orthopaedic & Occupational Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Rheumatology and Internal Medicine Associates of West County, P.C.
state: Missouri
city: Saint Louis
country: United States
facility: A & A Pain Institute
state: Missouri
city: Saint Louis
country: United States
facility: Arthritis Consultants Inc.
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Omaha
country: United States
facility: Westroads Medical Group
state: Nebraska
city: Edison
country: United States
facility: Anderson and Collins Clinical Research Inc.
state: New Jersey
city: Elizabeth
country: United States
facility: Central Jersey Medical Research Center
state: New Jersey
city: Freehold
country: United States
facility: Arthritis & Osteoporosis Associates, P.A.
state: New Jersey
city: Haddon Heights
country: United States
facility: Mark Fisher, MD, FACRUC
state: New Jersey
city: Passaic
country: United States
facility: New Jersey Physicians, LLC
state: New Jersey
city: Teaneck
country: United States
facility: Rheumatology Associates of North Jersey
state: New Jersey
city: Toms River
country: United States
facility: Arthritis & Osteoporosis Associates
state: New Jersey
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Voorhees
country: United States
facility: Arthritis, Rheumatic & Back Disease Associates
state: New Jersey
city: Albany
country: United States
facility: The Center for Rheumatology, LLP
state: New York
city: Bronx
country: United States
facility: SPRI Bronx LLC
state: New York
city: Brooklyn
country: United States
facility: Arthritis and Osteoporosis Associates of Brooklyn Heights
state: New York
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: Plainview
country: United States
facility: Prem C. Chatpar, MD, LLC
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group
state: New York
city: Greenville
country: United States
facility: Physicians East P. A.
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America, Inc
state: North Carolina
city: Hickory
country: United States
facility: Piedmont Rheumatology
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants Inc
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Fargo
country: United States
facility: Internal Medicine Associates
state: North Dakota
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Akron
country: United States
facility: Daystar Clinical Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Doctor's Urgent Care Offices
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Optimed Research, LTD
state: Ohio
city: Dayton
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Dayton Science Institute (DSI)
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Dayton
country: United States
facility: PHP - Center for Clinical Research
state: Ohio
city: Mayfield
country: United States
facility: David R. Mandel, MD, Inc
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest Rheumatology and Research Group, LLC
state: Ohio
city: Norman
country: United States
facility: Integris Family Care of Norman
state: Oklahoma
city: Norman
country: United States
facility: LION Research
state: Oklahoma
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Norman
country: United States
facility: Elise Wiesner, MD
state: Oklahoma
city: Norman
country: United States
facility: McBride Clinic, Inc
state: Oklahoma
city: Norman
country: United States
facility: McBride Clinic
state: Oklahoma
city: Oklahoma City
country: United States
facility: McBride Clinic, Inc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Bone and Joint Hospital at St. Anthony
state: Oklahoma
city: Oklahoma City
country: United States
facility: Christine Codding, MD
state: Oklahoma
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mc Bride Clinic
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Associated Orthopedics, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: Hillcrest Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Rheumatology Associates Inc
state: Oklahoma
city: Yukon
country: United States
facility: Aquilo Clinical Research
state: Oklahoma
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Altoona
country: United States
facility: Blair Orthopedics Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Clinton
country: United States
facility: The Family Healthcare Center, PA
state: South Carolina
city: Columbia
country: United States
facility: Columbia Arthritis Center P.A.
state: South Carolina
city: Columbia
country: United States
facility: Southern Orthopaedic Sports Medicine
state: South Carolina
city: Greer
country: United States
facility: Radiant Research Inc
state: South Carolina
city: Rock Hill
country: United States
facility: The Carolina Center for Rheumatology and Arthritis Care, PA
state: South Carolina
city: Rapid City
country: United States
facility: Regional Health Clinical Research
state: South Dakota
city: Rapid City
country: United States
facility: Regional Medical Clinical-Rheumatology
state: South Dakota
city: Jackson
country: United States
facility: Arthritis Clinic
state: Tennessee
city: Memphis
country: United States
facility: Ramesh C. Gupta, M.D.
state: Tennessee
city: Abilene
country: United States
facility: Abilene Arthritis Center
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Austin
country: United States
facility: Dr. Paul K. Pickrell (Physician's Office)
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: One Step Diagnostic
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Houston
country: United States
facility: Miracle Medical Center
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Lubbock
country: United States
facility: Gill Orthopedic Center
state: Texas
city: Lubbock
country: United States
facility: Robert R. King, M.D.
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology, PA
state: Texas
city: New Braunfels
country: United States
facility: Hill Country Medical Associates
state: Texas
city: New Braunfels
country: United States
facility: Neurology Clinic of Central Texas
state: Texas
city: Pasadena
country: United States
facility: Philip Blum
state: Texas
city: Pearland
country: United States
facility: Pearland Primary Care Associates
state: Texas
city: Pearland
country: United States
facility: Southwest Clinical Research Centers, LLC
state: Texas
city: Plano
country: United States
facility: Plano Primary Care Clinic
state: Texas
city: Plano
country: United States
facility: Advanced Family Medical Care
state: Texas
city: San Antonio
country: United States
facility: Alamo Clinical Research Associates
state: Texas
city: San Antonio
country: United States
facility: Alamo Clinical Research Consultants
state: Texas
city: San Antonio
country: United States
facility: Texas Arthritis Research Center, PA
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio
state: Texas
city: San Antonio
country: United States
facility: SAM Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Preventive & Diagnostic Medicine, PA
state: Texas
city: San Antonio
country: United States
facility: South Texas Radiology Imaging Center
state: Texas
city: San Antonio
country: United States
facility: The Rehab Group
state: Texas
city: Sugar Land
country: United States
facility: Sugar Land Med-Ped, PA
state: Texas
city: Temple
country: United States
facility: Scott & White Healthcare
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Midvale
country: United States
facility: Pivotal Research Centers
state: Utah
city: Salt Lake City
country: United States
facility: Optimum Clinical Research, Inc.
state: Utah
city: Salt Lake City
country: United States
facility: Radiant Research, Inc.
state: Utah
city: Portsmouth
country: United States
facility: Doris M. Rice, M.D., F.A.C.R.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research Richmond Inc.
state: Virginia
city: Roanoke
country: United States
facility: Hypothe Test, LLC
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Tacoma
country: United States
facility: Tacoma Center for Arthritis Research, PS
state: Washington
city: Onalaska
country: United States
facility: Gundersen Clinic Ltd.
state: Wisconsin
city: Lunenburg
country: Canada
facility: Office of Diane Wilson
state: Nova Scotia
city: Hamilton
country: Canada
facility: MAC Research Inc.
state: Ontario
city: Kitchener
country: Canada
facility: KW Musculoskeletal Research Inc.
state: Ontario
city: Newmarket
country: Canada
facility: The Arthritis Program Research Group
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: St. Catharines
country: Canada
facility: Dr. Saeed Shaikh
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil Gupta
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: St. Eustache
country: Canada
facility: Polyclinique St. Eustache
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Quebec
country: Canada
facility: Groupe de Recherche en Rhumatologie et Maladies Osseuses
city: Quebec
country: Canada
facility: Clinique Medicale St-Louis
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Bogota
country: Colombia
facility: Centro Integral de Reumatologia e Inmunologia CIREI
state: Cundinamarca
city: Bogota-Cundinamarca
country: Colombia
facility: Riesgo de Fractura S.A.
city: Medellin
country: Colombia
facility: Clinica Las Americas
city: Medellin
country: Colombia
facility: Reumatologya S.A.
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences Ltd., Department of Rheumatology
state: Andhra Pradesh
city: Bangalore
country: India
facility: St. Johns Medical College Hospital, Department of Orthopaedics
state: Karnataka
city: Bangalore
country: India
facility: M.S. Ramaiah Memorial Hospital, Department of Orthopaedics
state: Karnataka
city: Bangalore
country: India
facility: ChanRe Rheumatology & Immunology Center & Research
state: Karnataka
city: Mangalore
country: India
facility: KMC Hospital, Department of Orthopaedics
state: Karnataka
city: Pune
country: India
facility: Sancheti Hospital
state: Maharashtra
city: Coimbatore
country: India
facility: PSG Institute of Medical Sciences and Research
state: Tamilnadu
city: Lucknow
country: India
facility: CSM Medical University, Department of Rheumatology
state: UP
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
city: Guadalajara
country: Mexico
facility: URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de Guadalajara"Fray Antonio Alcalde"
state: Jalisco
city: Coahuila
country: Mexico
facility: Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C.
city: Culiacan Sinaloa
country: Mexico
facility: Hospital General de Culiacan, S.S., "Dr. Bernardo Gastelum".
city: Leon Gto
country: Mexico
facility: Hospital Aranda de la Parra
city: Torreon Coahuila
country: Mexico
facility: Beneficencia Espanola de la Laguna
city: Amsterdam
country: Netherlands
facility: READE
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Cebu City
country: Philippines
facility: Cebu Orthopedic Institute
city: Cebu City
country: Philippines
facility: Chong Hua Hospital, Medical Arts Center
city: Cebu City
country: Philippines
facility: Diaz Building
city: Davao City
country: Philippines
facility: Davao Doctors Hospital, Medical Tower
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Manila
country: Philippines
facility: Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center
city: Manila
country: Philippines
facility: Chinese General Hospital and Medical Center, Out Patient Department
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center
city: Moscow
country: Russian Federation
facility: State Healthcare Institution Moscow City Clinical Hospital #4
city: Moscow
country: Russian Federation
facility: State Healthcare Institution: Moscow City Clinical Hospital #7
city: Moscow
country: Russian Federation
facility: Institution Of Russian Academy of Medical Sciences
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Medical University named after Pavlov
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Healthcare Institution "City Hospital #26"
city: Panorama
country: South Africa
facility: 136 Panorama Medical Center
state: Cape Town
city: Mamelodi East
country: South Africa
facility: Phelang Private Hospital Research Unit
state: Pretoria
city: Bellville
country: South Africa
facility: Tiervlei Trial Center
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Cape Town
country: South Africa
facility: Vincent Pallotti Hospital
city: Durbanville
country: South Africa
facility: A. Briel
city: Durban
country: South Africa
facility: Private Practice
city: Durban
country: South Africa
facility: Randles Road Medical Center
city: Johannesburg
country: South Africa
facility: Origin Clinical Research
city: Kempton Park
country: South Africa
facility: Clinresco Centres (Pty) Ltd
city: Paarl
country: South Africa
facility: Paarl Research Center
city: Parrowvalley
country: South Africa
facility: TREAD Research
city: Pretoria
country: South Africa
facility: Clinical Research Unit
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia
state: Barcelona
city: Dos Hermanas
country: Spain
facility: Hospital El Tomillar
state: Sevilla
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario de A Coruna
city: Barakaldo (Vizcaya)
country: Spain
facility: Hospital de Cruces, Servicio de Reumatologia
city: Barcelona
country: Spain
facility: Clinica CIMA
city: Barcelona
country: Spain
facility: Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA
city: Madrid
country: Spain
facility: Hospital Universitario La Paz, Servicio de Reumatologia
city: Santiago De Compostela, A Coruna
country: Spain
facility: Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia
city: Sevilla
country: Spain
facility: Hospital Nuestra Senora de Valme, Servicio de Reumatologia
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Hospital
city: Donetsk
country: Ukraine
facility: City Clinical Hospital #5
city: Donetsk
country: Ukraine
facility: V.K. Gusak Institute of Urgent and Recovery Surgery
city: Kiev
country: Ukraine
facility: Kiev City Oleksandrivska Clinical Hospital
city: Kiev
country: Ukraine
facility: Kiev City Clinical Hospital #3
city: Kiev
country: Ukraine
facility: State Institution "Research Centre for Radiation Medicine AMS of Ukraine"
city: Kiev
country: Ukraine
facility: State Institution "Institute of Gerontology AMS of Ukraine"
city: Zaporizhzhya
country: Ukraine
facility: Municipal institution :Zaporizhzhya Regional Clinical Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019.
citation: Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
citation: Schnitzer TJ, Ekman EF, Spierings EL, Greenberg HS, Smith MD, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Ann Rheum Dis. 2015 Jun;74(6):1202-11. doi: 10.1136/annrheumdis-2013-204905. Epub 2014 Mar 13.