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Tanezumab in Osteoarthritis of the Hip or Knee (2)

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

tanezumab 10 mg

tanezumab 5 mg

naproxen

placebo

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

pregnancy or intent to become pregnant
BMI greater than 39
other severe pain, significant cardiac, neurological or psychiatric disease

Sites / Locations

Greystone Medical Research, LLC
Saadat Ansari, MD
Coastal Clinical Research, Inc.
Clinical Research Advantage, Inc. / Central Arizona Medical Associates, PC
Novara Clinical Research
Clinical Research Advantage, Inc.
Central Phoenix Medical - Clinical Research Advantage
Paradigm Clinical, Inc
eStudySite
Orthopedic Physicians of Colorado, PC
University Parks Hematology/Oncology
Edinger Medical Group and Research Center
Valley Research
Lakewood Orthopedic Medical & Surgical Group
High Desert Medical Group Research for Life
Premiere Clinical Research, LLC
Miracle Mile Medical Center
Samaritan Center for Medical Research
Del Carmen Medical Center
Probe Clinical Research, Corp.
Lawrence P.McAdam, MD, A Medical Corporation
Westlake Medical Center
Peak Anesthesia and Pain Management
Denver Internal Medicine Group
Mountain View Clinical Research, Inc.
Colorado Hematology
Colorado Orthopedic Consultants, PC
American Clinical Research, LLC
Norwalk Medical Group
Rheumatology Consultants of Delaware
HeartCare
In Vivo Clinical Research, Inc
S & W Clinical Research
Centre for Rheumatology, Immunology and Arthritis
Kendall South Medical Center, Inc
Sunshine Research Center
Rheumatology Associates of Central Florida, PA
HeartCare Research
Tampa Medical Group PA
Masters of Clinical Research, Inc.
River Birch Research Alliance, LLC
Millennium Pain Center
Rehabilitation Institute of Chicago
MediSphere Medical Research Center, LLC
Pasadena Pharmacy
The Pain Treatment Center of the Bluegrass
L-Marc Research Center
Bone and Joint Clinic of Baton Rouge
Gulf Coast Research, LLC
Mid-Atlantic Medical Research Centers
Beacon Clinical Research, LLC
Miray Medical Center
Great Lakes Research Group, Incorporated
Planters Clinic
Medex Healthcare Research, Inc.
St. John's Medical Research Institute, Inc.
Diagnositc Center of Medicine
Independent Clinical Researchers
Wolfson Medical Center
Clinical Research Consortium
SPRI Bronx LLC
Medex Healthcare Research, Inc.
Columbus Clinical Research, Inc.
Providence Health Partners - Center for Clinical Research
Orthopedic & Sports Medicine Consultants
Signal Point Clinical Research Center, LLC
Physicians' Research, Inc
PrimeCare of Southeastern Ohio, Inc
Cor Clinical Research, LLC
The Family Healthcare Center, PA
Southern Orthopaedic Sports Medicine
Coastal Carolina Research Center
Low Country Rheumatology, PA
The Carolina Center for Rheumatology and Arthritis Care, PA
Palmetto Clinical Trial Services, LLC
South Austin Orthopedics
Tekton Research Inc. - Research Office
Texas Orthopedic Specialists
Foundation for Southwest Orthopedic Research
Southwest Orthopedic Group
The Neurology Center
Gill Orthopedic Center
Robert R. King, M.D., PA
AZ Clinical Research
Spring Clinical Research
Sugar Land Med-Ped, P.A.
Grayline Clinical Drug Trials
J. Lewis Research, Inc. / Foothill Family Clinic
J. Lewis Research, Incorporated/Foothill Family Clinic South
Commonwealth Orthopedics & Rehabilitation , P.C.
IntegraTrials, LLC
Virginia Hospital Center
HypotheTest, LLC
Empirical Clinical Trials, LLC
Arthritis Northwest, PLLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)

PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.

Secondary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.

Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.

Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0%; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF)

Participants assessed their average daily pain score in the index hip/knee using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. A weekly mean was calculated using the daily index hip/knee pain scores within each specified study week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [worst stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no difficulty) to 10 (maximum difficulty), where higher scores indicated worse response.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF)

The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.

Time to Discontinuation Due to Lack of Efficacy

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.

Percentage of Participants Who Used Rescue Medication

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized.

Duration of Rescue Medication Use

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized.

Amount of Rescue Medication Taken

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Number of Participants With Laboratory Test Abnormalities

Laboratory values: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3*ULN), electrolytes (sodium<0.95* LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1).

Number of Participants With Abnormal Electrocardiogram (ECG) Findings

All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as treatment related adverse events were presented. Relatedness to treatment was assessed by investigator.

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24

NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 122 (maximum impairment), higher scores indicated increased impairment.

Number of Participants With Positive Anti-Drug Antibody (ADA) Level

Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: Tanezumab 5 mg + Placebo and Tanezumab 10 mg + Placebo. Results with titer value >= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive.

Number of Participants With Abnormal Physical Examinations Findings

Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others. Criteria for abnormal physical findings were based on investigator's discretion.

Number of Participants With Adverse Events Associated With Vital Sign Measurements

Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant vital signs (based on the investigator's judgment) considered as adverse events were reported.

Full Information

NCT ID

NCT00863304

First Posted

March 13, 2009

Last Updated

April 20, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00863304

Brief Title

Tanezumab in Osteoarthritis of the Hip or Knee (2)

Official Title

A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

June 9, 2009 (Actual)

Primary Completion Date

April 27, 2010 (Actual)

Study Completion Date

August 16, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

849 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

tanezumab 10 mg

Intervention Description

tanezumab 10 mg one dose at weeks 0 and 8

Intervention Type

Biological

Intervention Name(s)

tanezumab 5 mg

Intervention Description

tanezumab 5 mg one dose at weeks 0 and 8

Intervention Type

Drug

Intervention Name(s)

naproxen

Intervention Description

naproxen 1000 mg daily for 16 weeks

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

placebo to match tanezumab and naproxen dosing

Primary Outcome Measure Information:

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.

Time Frame

Baseline, Week 16

Title

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Baseline, Week 16

Secondary Outcome Measure Information:

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Baseline, Weeks 2, 4, 8, and 12

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 16

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.

Time Frame

Baseline, Weeks 2, 4, 8, and 12

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 16

Title

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Baseline, Weeks 2, 4, 8, and 12

Title

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 16

Title

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

Time Frame

Baseline up to Week 16

Title

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0%; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

Time Frame

Baseline up to Week 16

Title

Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 16

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness.

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 16

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [worst stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no difficulty) to 10 (maximum difficulty), where higher scores indicated worse response.

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 16

Title

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 16

Title

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 16

Title

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Baseline, Weeks 12, and 16

Title

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Baseline, Weeks 12, and 16

Title

Time to Discontinuation Due to Lack of Efficacy

Description

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.

Time Frame

Baseline up to Week 16

Title

Percentage of Participants Who Used Rescue Medication

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Duration of Rescue Medication Use

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Amount of Rescue Medication Taken

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Baseline (Day 1) up to Week 24

Title

Number of Participants With Laboratory Test Abnormalities

Description

Time Frame

Baseline (Day 1) up to Week 24

Title

Number of Participants With Abnormal Electrocardiogram (ECG) Findings

Description

Time Frame

Baseline (Day 1) up to Week 24

Title

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, and 24

Title

Number of Participants With Positive Anti-Drug Antibody (ADA) Level

Description

Time Frame

Baseline, Weeks 8, 16, and 24

Title

Number of Participants With Abnormal Physical Examinations Findings

Description

Time Frame

Baseline (Day 1)

Title

Number of Participants With Adverse Events Associated With Vital Sign Measurements

Description

Time Frame

Baseline (Day 1) up to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2 Exclusion Criteria: pregnancy or intent to become pregnant BMI greater than 39 other severe pain, significant cardiac, neurological or psychiatric disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Greystone Medical Research, LLC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35242

Country

United States

Facility Name

Saadat Ansari, MD

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Coastal Clinical Research, Inc.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Clinical Research Advantage, Inc. / Central Arizona Medical Associates, PC

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Facility Name

Novara Clinical Research

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Facility Name

Clinical Research Advantage, Inc.

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85213

Country

United States

Facility Name

Central Phoenix Medical - Clinical Research Advantage

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

Paradigm Clinical, Inc

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85705

Country

United States

Facility Name

eStudySite

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

Orthopedic Physicians of Colorado, PC

City

Englewood

State/Province

California

ZIP/Postal Code

80113

Country

United States

Facility Name

University Parks Hematology/Oncology

City

Englewood

State/Province

California

ZIP/Postal Code

80113

Country

United States

Facility Name

Edinger Medical Group and Research Center

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Valley Research

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Lakewood Orthopedic Medical & Surgical Group

City

Lakewood

State/Province

California

ZIP/Postal Code

90712

Country

United States

Facility Name

High Desert Medical Group Research for Life

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

Premiere Clinical Research, LLC

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

Miracle Mile Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Samaritan Center for Medical Research

City

Los Gatos

State/Province

California

ZIP/Postal Code

95032

Country

United States

Facility Name

Del Carmen Medical Center

City

Reseda

State/Province

California

ZIP/Postal Code

91335

Country

United States

Facility Name

Probe Clinical Research, Corp.

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Lawrence P.McAdam, MD, A Medical Corporation

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91360

Country

United States

Facility Name

Westlake Medical Center

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

Facility Name

Peak Anesthesia and Pain Management

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Denver Internal Medicine Group

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Mountain View Clinical Research, Inc.

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Colorado Hematology

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80110

Country

United States

Facility Name

Colorado Orthopedic Consultants, PC

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80110

Country

United States

Facility Name

American Clinical Research, LLC

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Norwalk Medical Group

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06851

Country

United States

Facility Name

Rheumatology Consultants of Delaware

City

Lewes

State/Province

Delaware

ZIP/Postal Code

19958

Country

United States

Facility Name

HeartCare

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34202

Country

United States

Facility Name

In Vivo Clinical Research, Inc

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

S & W Clinical Research

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33306

Country

United States

Facility Name

Centre for Rheumatology, Immunology and Arthritis

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33334

Country

United States

Facility Name

Kendall South Medical Center, Inc

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Sunshine Research Center

City

Opa-locka

State/Province

Florida

ZIP/Postal Code

33054

Country

United States

Facility Name

Rheumatology Associates of Central Florida, PA

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

HeartCare Research

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

Facility Name

Tampa Medical Group PA

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Masters of Clinical Research, Inc.

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

River Birch Research Alliance, LLC

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

Millennium Pain Center

City

Bloomington

State/Province

Illinois

ZIP/Postal Code

61701

Country

United States

Facility Name

Rehabilitation Institute of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

MediSphere Medical Research Center, LLC

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Pasadena Pharmacy

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

The Pain Treatment Center of the Bluegrass

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

L-Marc Research Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Bone and Joint Clinic of Baton Rouge

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Gulf Coast Research, LLC

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Mid-Atlantic Medical Research Centers

City

Hollywood

State/Province

Maryland

ZIP/Postal Code

20636

Country

United States

Facility Name

Beacon Clinical Research, LLC

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02301

Country

United States

Facility Name

Miray Medical Center

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02301

Country

United States

Facility Name

Great Lakes Research Group, Incorporated

City

Bay City

State/Province

Michigan

ZIP/Postal Code

48706

Country

United States

Facility Name

Planters Clinic

City

Port Gibson

State/Province

Mississippi

ZIP/Postal Code

39150

Country

United States

Facility Name

Medex Healthcare Research, Inc.

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

St. John's Medical Research Institute, Inc.

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Diagnositc Center of Medicine

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Independent Clinical Researchers

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89103

Country

United States

Facility Name

Wolfson Medical Center

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89103

Country

United States

Facility Name

Clinical Research Consortium

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

SPRI Bronx LLC

City

Bronx

State/Province

New York

ZIP/Postal Code

10454

Country

United States

Facility Name

Medex Healthcare Research, Inc.

City

New York

State/Province

New York

ZIP/Postal Code

10004

Country

United States

Facility Name

Columbus Clinical Research, Inc.

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Providence Health Partners - Center for Clinical Research

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45439

Country

United States

Facility Name

Orthopedic & Sports Medicine Consultants

City

Middletown

State/Province

Ohio

ZIP/Postal Code

45042

Country

United States

Facility Name

Signal Point Clinical Research Center, LLC

City

Middletown

State/Province

Ohio

ZIP/Postal Code

45042

Country

United States

Facility Name

Physicians' Research, Inc

City

Zanesville

State/Province

Ohio

ZIP/Postal Code

43701

Country

United States

Facility Name

PrimeCare of Southeastern Ohio, Inc

City

Zanesville

State/Province

Ohio

ZIP/Postal Code

43701

Country

United States

Facility Name

Cor Clinical Research, LLC

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

The Family Healthcare Center, PA

City

Clinton

State/Province

South Carolina

ZIP/Postal Code

29325

Country

United States

Facility Name

Southern Orthopaedic Sports Medicine

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Coastal Carolina Research Center

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Low Country Rheumatology, PA

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

The Carolina Center for Rheumatology and Arthritis Care, PA

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Palmetto Clinical Trial Services, LLC

City

Simpsonville

State/Province

South Carolina

ZIP/Postal Code

29681

Country

United States

Facility Name

South Austin Orthopedics

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Tekton Research Inc. - Research Office

City

Austin

State/Province

Texas

ZIP/Postal Code

78746

Country

United States

Facility Name

Texas Orthopedic Specialists

City

Grapevine

State/Province

Texas

ZIP/Postal Code

76051

Country

United States

Facility Name

Foundation for Southwest Orthopedic Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Southwest Orthopedic Group

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

The Neurology Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Gill Orthopedic Center

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Robert R. King, M.D., PA

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

AZ Clinical Research

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

Spring Clinical Research

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

Sugar Land Med-Ped, P.A.

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Grayline Clinical Drug Trials

City

Wichita Falls

State/Province

Texas

ZIP/Postal Code

76309

Country

United States

Facility Name

J. Lewis Research, Inc. / Foothill Family Clinic

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

J. Lewis Research, Incorporated/Foothill Family Clinic South

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Facility Name

Commonwealth Orthopedics & Rehabilitation , P.C.

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205

Country

United States

Facility Name

IntegraTrials, LLC

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205

Country

United States

Facility Name

Virginia Hospital Center

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205

Country

United States

Facility Name

HypotheTest, LLC

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Facility Name

Empirical Clinical Trials, LLC

City

Selah

State/Province

Washington

ZIP/Postal Code

98942

Country

United States

Facility Name

Arthritis Northwest, PLLC

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204-2336

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

30936738

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. Erratum In: J Pain Res. 2020 Sep 14;13:2267-2268.

Results Reference

derived

PubMed Identifier

25274899

Citation

Ekman EF, Gimbel JS, Bello AE, Smith MD, Keller DS, Annis KM, Brown MT, West CR, Verburg KM. Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: 2 randomized controlled trials versus naproxen. J Rheumatol. 2014 Nov;41(11):2249-59. doi: 10.3899/jrheum.131294. Epub 2014 Oct 1.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091018&StudyName=Tanezumab%20in%20osteoarthritis%20of%20the%20hip%20or%20knee%20%282%29

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

Tanezumab in Osteoarthritis of the Hip or Knee (2)

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