Study Stopped
See termination reason in detailed description.
Tanezumab and Nerve Function In Arthritis Patients
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY OF TANEZUMAB ON PERIPHERAL NERVE FUNCTION IN PATIENTS WITH OSTEOARTHRITIS.
2 other identifiers
interventional
220
1 country
97
Brief Summary
Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2009
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedStudy Start
First participant enrolled
May 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2010
CompletedResults Posted
Study results publicly available
February 4, 2021
CompletedFebruary 4, 2021
December 1, 2020
1.5 years
March 17, 2009
January 13, 2021
January 13, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Intent to Treat (ITT) Analysis Set
5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency \[MNDL\],peroneal nerve compound muscle action potential\[CMAP\],peroneal motor nerve conduction velocity\[MNCV\],tibial MNDL,sural sensory nerve action potential amplitude \[SNAP\])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score \>0=worse response,less than(\<)0=better response compared to normal matched population.Score change\>0=worsening,\<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.
Baseline, Week 24
Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Per Protocol Analysis Set (PPAS)
5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency \[MNDL\],peroneal nerve compound muscle action potential\[CMAP\],peroneal motor nerve conduction velocity\[MNCV\],tibial MNDL,sural sensory nerve action potential amplitude \[SNAP\])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score \>0=worse response,less than(\<)0=better response compared to normal matched population.Score change\>0=worsening,\<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.
Baseline, Week 24
Secondary Outcomes (38)
Change From Baseline in Neuropathy Impairment Score - Lower Limbs [NIS (LL)] at Week 24
Baseline, Week 24
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24
Baseline, Week 24
Change From Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24
Baseline, Week 24
Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: ITT Analysis Set
Baseline, Week 24
Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: PPAS
Baseline, Week 24
- +33 more secondary outcomes
Other Outcomes (1)
Number of Participants With Intravenous Doses of Study Medication
Day 1 up to Week 24
Study Arms (3)
Tanezumab 5 mg
EXPERIMENTALTanezumab 10 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- BMI less or equal to 39 kg/m2
- Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies
- Willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
- Patients must consent in writing to participate in the study.
You may not qualify if:
- Untreated, uncontrolled diseases,
- Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
- Significant cardiac disease within the past 6 months
- Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis, stroke) or signs of neuropathy at screening
- Known bleeding disorder or anticoagulation therapy
- Planned surgery during the study period
- History of alcoholism or drug abuse in the past 2 years
- Unable to use acetaminophen
- Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
- Allergic reaction to a biologic or an antibody in the past
- Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
- Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.
- Medical condition that may interfere with study endpoints or safety of the subject as determined by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (97)
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
JDP Medical Research, LLC
Aurora, Colorado, 80014, United States
Alpine Neurology
Centennial, Colorado, 80112, United States
Peak Anesthesia
Centennial, Colorado, 80112, United States
JEM Research, LLC
Atlantis, Florida, 33462, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, 33462, United States
Bradenton Research Center, Inc
Bradenton, Florida, 34205, United States
Manatee Internal Medicine
Bradenton, Florida, 34208, United States
Clinical Physiology Associates
Fort Myers, Florida, 33916, United States
Harris Bonnette, MD
Fort Myers, Florida, 33919, United States
Sunrise Clinical Research, Inc.
Hollywood, Florida, 33021, United States
Sunrise Clinical Research, Inc
Hollywood, Florida, 33024, United States
Pharmax Research Clinic, Inc
Miami, Florida, 33126, United States
International Research Associates, LLC
Miami, Florida, 33183, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
Pines Neurological Associates
Pembroke Pines, Florida, 33026, United States
Pembroke Clinical Trials
Pembroke Pines, Florida, 33028, United States
Pines Neurological Associates
Pembroke Pines, Florida, 33028, United States
Advent Clinical Research Centers, Inc
Pinellas Park, Florida, 33781, United States
Advent Clinical Research Center
Pinellas Park, Florida, 33781, United States
Berma Research Group
Plantation, Florida, 33317, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, 34232, United States
Ronal Aung-Din, MD
Sarasota, Florida, 34232, United States
Ronald Aung-Din, MD
Sarasota, Florida, 34232, United States
Sarasota Center for Clinical Research
Sarasota, Florida, 34232, United States
Arthritis & Rheumatic Care Center
South Miami, Florida, 33143, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Neuroscience Consultants, LLC
South Miami, Florida, 33143, United States
Carol L. Pappas MD, PhD
St. Petersburg, Florida, 33713, United States
Carol L. Pappas, M.D. PhD
St. Petersburg, Florida, 33713, United States
Dale G. Bramlet, MD, P.L.
St. Petersburg, Florida, 33713, United States
Tampa Neurology Associates
Tampa, Florida, 33609, United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614, United States
Radiology Associates of Venice & Englewood
Venice, Florida, 34285, United States
Lovelace Scientific Resources, Inc
Venice, Florida, 34292, United States
Venice Arthritis Center
Venice, Florida, 34292, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Atlanta Neurology
Atlanta, Georgia, 30342, United States
Diagnostic Imaging of Atlanta
Atlanta, Georgia, 30342, United States
NeuroTrials Research, Incorporated
Atlanta, Georgia, 30342, United States
Northwest Neurology, P.C.
Austell, Georgia, 30106, United States
Atlanta Knee and Sports Medicine
Decatur, Georgia, 30033, United States
Joseph D. Weissman, MD
Decatur, Georgia, 30033, United States
Neurology Specialists of Decatur
Decatur, Georgia, 30033, United States
Southeastern Center for Clinical Trials
Decatur, Georgia, 30033, United States
Jefrey D. Lieberman, MD
Decatur, Georgia, 30333, United States
Northwestern Lake Forest Hospital Diagnostic Imaging Centers
Bannockburn, Illinois, 60015, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Consultants in Neurology, Ltd.
Northbrook, Illinois, 60062, United States
Elkhart Clinic, LLC
Elkhart, Indiana, 46514, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University Hospital
Indianapolis, Indiana, 46202, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
G. Timothy Kelly, MD
Las Vegas, Nevada, 89128, United States
Clinical Neurology Specialists
Las Vegas, Nevada, 89146, United States
Neurological Associates of Long Island, P.C.
Lake Success, New York, 11042, United States
Andrew J. Porges, M.D. PC
Roslyn, New York, 11576, United States
Asheville Imaging
Asheville, North Carolina, 28801, United States
Biltmore Medical Associates
Asheville, North Carolina, 28801, United States
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, 28803, United States
Asheville Neurology
Asheville, North Carolina, 28806-2287, United States
Unifour Medical Research Associates, LLC
Hickory, North Carolina, 28601, United States
Neurology Associates, PA
Hickory, North Carolina, 28602, United States
Unifour Medical Research Associates, LLC
Hickory, North Carolina, 28602, United States
Caldwell Memorial Hospital
Lenoir, North Carolina, 28645, United States
Northstate Clinical Research
Lenoir, North Carolina, 28645, United States
Ohio Research Center
Toledo, Ohio, 43623, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
North Star Neurology
Bend, Oregon, 97701, United States
Altoona Hospital Campus
Altoona, Pennsylvania, 16601, United States
Blair Neurologic Associates
Altoona, Pennsylvania, 16601, United States
Blair Medical Associates
Altoona, Pennsylvania, 16602, United States
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, 16602, United States
Bon Secour Campus
Altoona, Pennsylvania, 16602, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Coastal Carolina Research Center in Goose Creek
Goose Creek, South Carolina, 29445, United States
Tidewater Neurology
Goose Creek, South Carolina, 29445, United States
AAMR Research Clinic, PA
Amarillo, Texas, 79106, United States
Amarillo Diagnostic Clinic
Amarillo, Texas, 79106, United States
Radiant Research, Inc.
Dallas, Texas, 75231, United States
Dr. Michael Vengrow
Dallas, Texas, 75243, United States
Foundation for Southwest Orthopedic Research
Houston, Texas, 77030, United States
The Neurology Center
Houston, Texas, 77030, United States
Paragon Research Center, LLC
San Antonio, Texas, 78205, United States
Baptist M&S Imaging
San Antonio, Texas, 78215, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Christine L. Truitt, MD
San Antonio, Texas, 78229, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Neurodiagnostic Laboratories of San Antonio, Inc.
San Antonio, Texas, 78229, United States
Neurodiagnostic Laboratories of San Antonio, Inc
San Antonio, Texas, 78229, United States
Radiant Research Inc.
San Antonio, Texas, 78229, United States
IntegraTrials, L.L.C
Arlington, Virginia, 22205, United States
TLC Neurology, P.L.L.C
Arlington, Virginia, 22205, United States
Virginia Hospital Center
Arlington, Virginia, 22205, United States
Hypothe Test, LLC
Roanoke, Virginia, 24014, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Evergreen Neurology and Neurodiagnostics, PLLC
Everett, Washington, 98201, United States
Related Publications (3)
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.
PMID: 37460782DERIVEDTive 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.
PMID: 30936738DERIVEDBrown MT, Herrmann DN, Goldstein M, Burr AM, Smith MD, West CR, Verburg KM, Dyck PJ. Nerve safety of tanezumab, a nerve growth factor inhibitor for pain treatment. J Neurol Sci. 2014 Oct 15;345(1-2):139-47. doi: 10.1016/j.jns.2014.07.028. Epub 2014 Jul 18.
PMID: 25073573DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to US FDA imposed clinical hold (effective 23 June 2010), study was terminated early and planned sample size was not achieved. Due to change in planned analysis pre-specified outcome measure 'time to discontinuation due to lack of efficacy' was removed.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2009
First Posted
March 18, 2009
Study Start
May 18, 2009
Primary Completion
November 16, 2010
Study Completion
November 16, 2010
Last Updated
February 4, 2021
Results First Posted
February 4, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.