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Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Tanezumab 2.5 mg

Tanezumab 2.5mg/5mg

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis of the knee, osteoarthritis of the hip, nerve growth factor inhibitor, tanezumab

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray
Documented history that subject tried the following medications and had insufficient pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either tramadol or opioids
Meet the protocol requirements for pain at screening and pain, physical function and patient global assessment of osteoarthritis at baseline
Willing to discontinue all pain medications except study medication and rescue medication during the course of the study and use those as directed per protocol
Women able to have children must agree to use 2 forms of contraception during the study

Exclusion Criteria:

Body Mass Index (BMI) greater than 39
History of diseases other than osteoarthritis in a shoulder, hip or knee (example, rheumatoid arthritis, gout, joint infections, osteonecrosis)
Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or certain types of fractures
Patients who have had significant trauma or surgery to a knee, hip or shoulder within the previous year
Planned surgical procedure during the study
Patients who are largely or wholly incapacitated (example bedridden or confined to a wheelchair, permitting little or no self-care)
Patients who would be unwilling or unable to undergo joint replacement surgery if one eventually became necessary
Patients with significant conditions other than osteoarthritis that could interfere with assessment of pain in the joints (example fibromyalgia, lupus erythematosus)
Patients with significant heart, neurological or psychiatric diseases
Patients who had cancer other than certain skin cancers within the past 5 years
Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2 years
Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed during the course of the study.

Sites / Locations

Alabama Orthopaedic Surgeons
Cahaba Research, Inc.
Arizona Research Center
Clinical Research Institute of Arizona, LLC
Tucson Orthopaedic Institute
University of Arizona Clinical and Translational Science Research Center
Baptist Health Center for Clinical Research
Advanced Research Center, Inc
Medvin Clinical Research
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Irvine Center for Clinical Research
Robert L Freed, M.D., F.A.C.R / Clinical Interventions Research Institute
Providence Clinical Research
Artemis Institute for Clinical Research
California Research Foundation
Inland Rheumatology Clinical Trials, Inc.
Alpine Clinical Research Center
New England Research Associates, LLC
Stamford Therapeutics Consortium
Clinical Physiology Associates
Eastern Research, Inc.
South Florida Research Center, Inc.
New Horizon Research Center
Miami Dade Medical Research Institute, LLC
Compass Research, LLC
Ormond Beach Clinical Research
Phoenix Clinical Research, LLC
Bioclinica Research
Atlanta Center for Medical Research
Center for Advanced Research & Education (CARE)
East-West Medical Research Institute
Medex Healthcare Research Inc
Chicago Clinical Research Institute, Inc.
Northwestern University Feinberg School of Medicine
Great Lakes Clinical Trials
Investigators Research Group, LLC
Integrated Clinical Trial Services, Inc.
Professional Research Network of Kansas, LLC
George Stanley Walker, MD
Tristan Medical Enterprises, PC dba Regeneris Medical
Michigan Orthopaedic & Spine Surgeons
Arthritis and Osteoporosis Treatment and Research Center
Office Of Stephen H. Miller, M.D.
Arthritis And Osteoporosis Associates
New Mexico Clinical Research & Osteoporosis Center, Inc.
Drug Trials America
Wake Research Associates, LLC
Plains Clinical Research Center, LLC
Prestige Clinical Research
AC Clinical Research
NPC Research
Hillcrest Clinical Research
University Orthopedics Center
Palmetto Clinical Trial Services, LLC
Health Concepts
Quality Medical Research
KRK Medical Research
Tekton Research, Inc
Urgent Care MD's
Arthritis Care and Diagnostic Center
T&R Clinic, PA
Centex Studies, Inc.
BI Research Center
The Pain Relief Center
Center for Arthritis and Rheumatic Diseases
Spectrum Medical, Inc
National Clinical Research - Richmond, Inc
Northwest Clinical Research Center
Aggarwal and Associates Limited
Manna Research Inc. (Burlington south)
Dawson Road Medical Centre
Adachi Medicine Professional Corporation
K-W Musculoskeletal Research Inc.
Western Center for Public Health and Family Medicine
Malton Medical Centre
Rebecca Medical Associates
King Street Medical Clinic
Bluewater Clinical Research Group
Diex Recheche Montreal, Inc.
Alpha Recherche Clinique
Diex Research Sherbrooke Inc.
Recherche Clinique Sigma inc
Diex Recherche Quebec Inc.
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Centre de recherche Saint-Louis
Puerto Rico Medical Research Inc.
Mindful Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Tanezumab 2.5 mg

Tanezumab 2.5mg/5mg

Arm Description

placebo administered subcutaneously at day 0 and week 8

tanezumab 2.5 mg administered subcutaneously at day 0 and week 8

tanezumab 2.5 mg administered subcutaneously at day 0 and tanezumab 5 mg administered subcutaneously at week 8

Outcomes

Primary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme 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

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16

PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no 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 worsening of 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

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.

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

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme difficulty), where higher scores indicated maximum difficulty/worse physical function.

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24

Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was greater than or equal to (>=) 50 percent and greater or equal to (>=) 2 units in either WOMAC pain subscale or physical function subscale score; if change (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 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [extreme difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).

Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response

Percentage of participants with reduction in WOMAC pain intensity of at least (>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16 and 24 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.

Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint 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 (extreme pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (extreme 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 to Week 16 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.

Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response

Percentage of participants with reduction in WOMAC physical function of at least (>=) 30%, 50%, 70% and 90% at weeks 2, 4, 8, 12, 16 and 24 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours,calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.

Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty),higher scores indicate extreme difficulty/worse physical function. Percentage of participants with cumulative reduction (as percent) (greater than 0 %; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC physical function subscale from Baseline to Week 16 were reported. Missing data was imputed using mixed BOCF/LOCF.

Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis

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 1-5, where, 1=very good (no symptom and no 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. Percentage of participants with improvement of at least 2 points from Baseline in PGA of osteoarthritis were reported. Missing data was imputed using mixed BOCF/LOCF.

Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16

Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.

Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24

Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain) weekly beginning at Week 16. Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including the given 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 at Weeks 2, 4, 8, 12 and 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme stiffness), where higher scores indicated higher stiffness.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24

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

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 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24

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 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, 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 a Flat Surface) at Weeks 2, 4, 8, 12 and 16

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 (extreme pain), where higher scores indicated higher pain.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 24

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 (extreme 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

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 (extreme 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 Week 24

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 (extreme pain), where higher scores indicated higher pain.

Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline

WPAI is 6-question participant rated questionnaire to determine the impact of osteoarthritis on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16

European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score

EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The health utility score for a patient with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a patient reports greater levels of problems across the five dimensions.

European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value

EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are <=1. The Overall health utility score for a patient with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a patient reports greater levels of problems across the five dimensions.

Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Visits of services directly related to osteoarthritis evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.

Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who visited the emergency room due to osteoarthritis (OA).

Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of visits to the emergency room due to OA.

Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who were hospitalized due to OA.

Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of nights stayed in the hospital due to OA.

Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.

Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. Domain evaluated was number of participants who quit job due to OA.

Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. Domain evaluated was duration since quitting job due to OA.

Number of Participants Who Withdrew Due to Lack of Efficacy

Number of participants who withdrew from treatment due to lack of efficacy have been reported here.

Time to Discontinuation Due to Lack of Efficacy

Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.

Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16

In case of inadequate pain relief, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 16. Number of participants with any use of rescue medication during the particular study week were summarized.

Number of Participants Who Took Rescue Medication During Week 24

In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during the 4 weeks up to the particular study week were summarized.

Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16

In case of inadequate pain relief during the treatment period, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.

Number of Days of Rescue Medication Use at Week 24

In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days per week the participants used the rescue medication during the 4 weeks up to the particular study week were summarized.

Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16

In case of inadequate pain relief , acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams 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. 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 were events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

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

Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.

Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline

Primary Abnormality criteria: hemoglobin; hematocrit; RBC count [less than{<}0.8* lower limit of normal[LLN]; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes,Leukocytes,Neutrophils <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; Prothrombin time/Intl. normalized ratio >1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN;Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN, specific gravity <1.003, >1.030; pH<4.5, >8; Urine Leukocytes >=20.

Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline

Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Leukocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; Prothrombin time/Intl. normalized ratio >1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; Urine erythrocytes >=20.

Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40

Measurement of BP included sitting systolic (SBP) and diastolic BP (DBP).

Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40

Heart rate was measured at sitting position.

Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40

A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, QTcF, RR intervals) were collected.

Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40

Percentage of Participants With Adjudicated Joint Safety Outcomes

Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.

Percentage of Participants With Total Joint Replacements

Percentage of participants who underwent total knee, hip or shoulder joint replacement surgery.

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40

NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.

Number of Participants With Confirmed Orthostatic Hypotension

Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.

Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40

The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.

Number of Participants With Anti-Tanezumab Antibodies

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level >=3.32. Less than 3.32 was considered below the limit of quantitation.

Full Information

NCT ID

NCT02697773

First Posted

February 11, 2016

Last Updated

April 30, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02697773

Brief Title

Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

Official Title

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF A DOSE TITRATION REGIMEN FOR THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

January 21, 2016 (Actual)

Primary Completion Date

December 5, 2017 (Actual)

Study Completion Date

May 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study also evaluates the safety of the treatment regimens.

6. Conditions and Keywords

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

Osteoarthritis, Knee, Osteoarthritis, Hip

Keywords

osteoarthritis of the knee, osteoarthritis of the hip, nerve growth factor inhibitor, tanezumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

698 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo administered subcutaneously at day 0 and week 8

Arm Title

Tanezumab 2.5 mg

Arm Type

Experimental

Arm Description

tanezumab 2.5 mg administered subcutaneously at day 0 and week 8

Arm Title

Tanezumab 2.5mg/5mg

Arm Type

Experimental

Arm Description

tanezumab 2.5 mg administered subcutaneously at day 0 and tanezumab 5 mg administered subcutaneously at week 8

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Patient receives one dose of placebo to match tanezumab subcutaneously on Day 1 and one dose of placebo to match tanezumab subcutaneously at Week 8.

Intervention Type

Biological

Intervention Name(s)

Tanezumab 2.5 mg

Intervention Description

Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 2.5 mg subcutaneously at Week 8.

Intervention Type

Biological

Intervention Name(s)

Tanezumab 2.5mg/5mg

Other Intervention Name(s)

Titration Arm

Intervention Description

Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.

Primary Outcome Measure Information:

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme pain), where higher scores indicated higher pain.

Time Frame

Baseline, Week 16

Title

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

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.

Time Frame

Baseline, Week 16

Title

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16

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

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.

Time Frame

Baseline, Weeks 2, 4, 8 and 12

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.

Time Frame

Baseline, Week 24

Title

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

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme difficulty), where higher scores indicated extreme difficulty/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 Week 24

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 (extreme difficulty), where higher scores indicated maximum difficulty/worse physical function.

Time Frame

Baseline, Week 24

Title

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12

Description

Time Frame

Baseline, Weeks 2, 4, 8 and 12

Title

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24

Description

Time Frame

Baseline, Week 24

Title

Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

Description

Time Frame

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

Title

Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response

Description

Time Frame

Week 2, 4, 8, 12, 16 and 24

Title

Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint 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 (extreme pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (extreme 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 to Week 16 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.

Time Frame

Baseline to Week 16

Title

Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response

Description

Time Frame

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

Title

Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16

Description

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty),higher scores indicate extreme difficulty/worse physical function. Percentage of participants with cumulative reduction (as percent) (greater than 0 %; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC physical function subscale from Baseline to Week 16 were reported. Missing data was imputed using mixed BOCF/LOCF.

Time Frame

Baseline to Week 16

Title

Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis

Description

Time Frame

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

Title

Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16

Description

Time Frame

Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16

Title

Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24

Description

Time Frame

Baseline, Weeks 20 and 24

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16

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 at Week 24

Description

Time Frame

Baseline, Week 24

Title

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

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 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.

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 Week 24

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 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.

Time Frame

Baseline, Week 24

Title

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 and 16

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 (extreme pain), where higher scores indicated higher pain.

Time Frame

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

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 24

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 (extreme pain), where higher scores indicated higher pain.

Time Frame

Baseline, Week 24

Title

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

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 (extreme pain), where higher scores indicated higher pain.

Time Frame

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

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24

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 (extreme pain), where higher scores indicated higher pain.

Time Frame

Baseline, Week 24

Title

Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline

Description

Time Frame

Baseline

Title

Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16

Description

Time Frame

Baseline and Week 16

Title

European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score

Description

Time Frame

Baseline, Weeks 8 and 16

Title

European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value

Description

Time Frame

Baseline, Weeks 8 and 16

Title

Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis

Description

Time Frame

Baseline, Weeks 24 and 40

Title

Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis

Description

Time Frame

Baseline, Weeks 24 and 40

Title

Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis

Description

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of visits to the emergency room due to OA.

Time Frame

Baseline, Weeks 24 and 40

Title

Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis

Description

Time Frame

Baseline, Weeks 24 and 40

Title

Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis

Description

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of nights stayed in the hospital due to OA.

Time Frame

Baseline, Weeks 24 and 40

Title

Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things

Description

Time Frame

Baseline, Weeks 24 and 40

Title

Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis

Description

Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. Domain evaluated was number of participants who quit job due to OA.

Time Frame

Baseline, Weeks 24 and 40

Title

Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis

Description

Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. Domain evaluated was duration since quitting job due to OA.

Time Frame

Baseline, Weeks 24 and 40

Title

Number of Participants Who Withdrew Due to Lack of Efficacy

Description

Number of participants who withdrew from treatment due to lack of efficacy have been reported here.

Time Frame

Baseline up to Week 16

Title

Time to Discontinuation Due to Lack of Efficacy

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16

Description

Time Frame

Week 2, 4, 8, 12 and 16

Title

Number of Participants Who Took Rescue Medication During Week 24

Description

Time Frame

Week 24

Title

Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16

Description

Time Frame

Week 2, 4, 8, 12, 16

Title

Number of Days of Rescue Medication Use at Week 24

Description

In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days per week the participants used the rescue medication during the 4 weeks up to the particular study week were summarized.

Time Frame

Week 24

Title

Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16

Description

Time Frame

Week 2, 4, 8, 12, 16

Title

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

Description

Time Frame

Baseline up to Week 40

Title

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

Description

Time Frame

Baseline up to Week 40

Title

Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline

Description

Time Frame

Baseline up to Week 40

Title

Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline

Description

Time Frame

Baseline up to Week 40

Title

Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40

Description

Measurement of BP included sitting systolic (SBP) and diastolic BP (DBP).

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 40

Title

Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40

Description

Heart rate was measured at sitting position.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24 and 40

Title

Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40

Description

Time Frame

Baseline, Weeks 16, 40

Title

Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40

Time Frame

Baseline, Weeks 16 and 40

Title

Percentage of Participants With Adjudicated Joint Safety Outcomes

Description

Time Frame

Baseline up to Week 40

Title

Percentage of Participants With Total Joint Replacements

Description

Percentage of participants who underwent total knee, hip or shoulder joint replacement surgery.

Time Frame

Baseline up to Week 40

Title

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40

Description

Time Frame

Baseline, Weeks 2, 4, 8,12,16, 24 and 40

Title

Number of Participants With Confirmed Orthostatic Hypotension

Description

Time Frame

Baseline up to Week 40

Title

Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40

Description

Time Frame

Baseline, Weeks 24 and 40

Title

Number of Participants With Anti-Tanezumab Antibodies

Description

Time Frame

Baseline, Weeks 8,16, 24 and 40

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray Documented history that subject tried the following medications and had insufficient pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either tramadol or opioids Meet the protocol requirements for pain at screening and pain, physical function and patient global assessment of osteoarthritis at baseline Willing to discontinue all pain medications except study medication and rescue medication during the course of the study and use those as directed per protocol Women able to have children must agree to use 2 forms of contraception during the study Exclusion Criteria: Body Mass Index (BMI) greater than 39 History of diseases other than osteoarthritis in a shoulder, hip or knee (example, rheumatoid arthritis, gout, joint infections, osteonecrosis) Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or certain types of fractures Patients who have had significant trauma or surgery to a knee, hip or shoulder within the previous year Planned surgical procedure during the study Patients who are largely or wholly incapacitated (example bedridden or confined to a wheelchair, permitting little or no self-care) Patients who would be unwilling or unable to undergo joint replacement surgery if one eventually became necessary Patients with significant conditions other than osteoarthritis that could interfere with assessment of pain in the joints (example fibromyalgia, lupus erythematosus) Patients with significant heart, neurological or psychiatric diseases Patients who had cancer other than certain skin cancers within the past 5 years Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2 years Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed during the course of the study.

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

Alabama Orthopaedic Surgeons

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35235

Country

United States

Facility Name

Cahaba Research, Inc.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35242

Country

United States

Facility Name

Arizona Research Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Clinical Research Institute of Arizona, LLC

City

Surprise

State/Province

Arizona

ZIP/Postal Code

85374

Country

United States

Facility Name

Tucson Orthopaedic Institute

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85714

Country

United States

Facility Name

University of Arizona Clinical and Translational Science Research Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Baptist Health Center for Clinical Research

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Advanced Research Center, Inc

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

Medvin Clinical Research

City

Covina

State/Province

California

ZIP/Postal Code

91722

Country

United States

Facility Name

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Irvine Center for Clinical Research

City

Irvine

State/Province

California

ZIP/Postal Code

92614

Country

United States

Facility Name

Robert L Freed, M.D., F.A.C.R / Clinical Interventions Research Institute

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Facility Name

Providence Clinical Research

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Artemis Institute for Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

California Research Foundation

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Inland Rheumatology Clinical Trials, Inc.

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Alpine Clinical Research Center

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

Facility Name

New England Research Associates, LLC

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606

Country

United States

Facility Name

Stamford Therapeutics Consortium

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Clinical Physiology Associates

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Eastern Research, Inc.

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33013

Country

United States

Facility Name

South Florida Research Center, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

New Horizon Research Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Miami Dade Medical Research Institute, LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Compass Research, LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Ormond Beach Clinical Research

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Phoenix Clinical Research, LLC

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

Bioclinica Research

City

The Villages

State/Province

Florida

ZIP/Postal Code

32162

Country

United States

Facility Name

Atlanta Center for Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Center for Advanced Research & Education (CARE)

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

East-West Medical Research Institute

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Medex Healthcare Research Inc

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60602

Country

United States

Facility Name

Chicago Clinical Research Institute, Inc.

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Great Lakes Clinical Trials

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Investigators Research Group, LLC

City

Brownsburg

State/Province

Indiana

ZIP/Postal Code

46112

Country

United States

Facility Name

Integrated Clinical Trial Services, Inc.

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50265

Country

United States

Facility Name

Professional Research Network of Kansas, LLC

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205-1138

Country

United States

Facility Name

George Stanley Walker, MD

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Tristan Medical Enterprises, PC dba Regeneris Medical

City

North Attleboro

State/Province

Massachusetts

ZIP/Postal Code

02760

Country

United States

Facility Name

Michigan Orthopaedic & Spine Surgeons

City

Rochester Hills

State/Province

Michigan

ZIP/Postal Code

48307

Country

United States

Facility Name

Arthritis and Osteoporosis Treatment and Research Center

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Office Of Stephen H. Miller, M.D.

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89144

Country

United States

Facility Name

Arthritis And Osteoporosis Associates

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

New Mexico Clinical Research & Osteoporosis Center, Inc.

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Drug Trials America

City

Hartsdale

State/Province

New York

ZIP/Postal Code

10530

Country

United States

Facility Name

Wake Research Associates, LLC

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Plains Clinical Research Center, LLC

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58104

Country

United States

Facility Name

Prestige Clinical Research

City

Franklin

State/Province

Ohio

ZIP/Postal Code

45005

Country

United States

Facility Name

AC Clinical Research

City

Tiffin

State/Province

Ohio

ZIP/Postal Code

44883

Country

United States

Facility Name

NPC Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

Hillcrest Clinical Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73119

Country

United States

Facility Name

University Orthopedics Center

City

State College

State/Province

Pennsylvania

ZIP/Postal Code

16801

Country

United States

Facility Name

Palmetto Clinical Trial Services, LLC

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Health Concepts

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Facility Name

Quality Medical Research

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37211

Country

United States

Facility Name

KRK Medical Research

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

Tekton Research, Inc

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Urgent Care MD's

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521

Country

United States

Facility Name

Arthritis Care and Diagnostic Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

T&R Clinic, PA

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76117

Country

United States

Facility Name

Centex Studies, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

BI Research Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

The Pain Relief Center

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

Center for Arthritis and Rheumatic Diseases

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Spectrum Medical, Inc

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

National Clinical Research - Richmond, Inc

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Northwest Clinical Research Center

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

Facility Name

Aggarwal and Associates Limited

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

Manna Research Inc. (Burlington south)

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7R 1A4

Country

Canada

Facility Name

Dawson Road Medical Centre

City

Guelph

State/Province

Ontario

ZIP/Postal Code

N1H 1B1

Country

Canada

Facility Name

Adachi Medicine Professional Corporation

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

K-W Musculoskeletal Research Inc.

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 5N6

Country

Canada

Facility Name

Western Center for Public Health and Family Medicine

City

London

State/Province

Ontario

ZIP/Postal Code

N6G 2M1

Country

Canada

Facility Name

Malton Medical Centre

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L4V 1P1

Country

Canada

Facility Name

Rebecca Medical Associates

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6K 1J6

Country

Canada

Facility Name

King Street Medical Clinic

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1H 1G6

Country

Canada

Facility Name

Bluewater Clinical Research Group

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Diex Recheche Montreal, Inc.

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2Y 1S1

Country

Canada

Facility Name

Alpha Recherche Clinique

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G3K 2P8

Country

Canada

Facility Name

Diex Research Sherbrooke Inc.

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1L 0H8

Country

Canada

Facility Name

Recherche Clinique Sigma inc

City

Quebec

ZIP/Postal Code

G1G 3Y8

Country

Canada

Facility Name

Diex Recherche Quebec Inc.

City

Quebec

ZIP/Postal Code

G1S 2L6

Country

Canada

Facility Name

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Centre de recherche Saint-Louis

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Puerto Rico Medical Research Inc.

City

Ponce

ZIP/Postal Code

00717

Country

Puerto Rico

Facility Name

Mindful Medical Research

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

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

36301512

Citation

Atkinson J, Edwards RA, Bonfanti G, Barroso J, Schnitzer TJ. A Two-Step, Trajectory-Focused, Analytics Approach to Attempt Prediction of Analgesic Response in Patients with Moderate-to-Severe Osteoarthritis. Adv Ther. 2023 Jan;40(1):252-264. doi: 10.1007/s12325-022-02336-6. Epub 2022 Oct 27.

Results Reference

derived

PubMed Identifier

35980115

Citation

Mease P, Kuritzky L, Wright WL, Mallick-Searle T, Fountaine R, Yang R, Sadrarhami M, Faison W, Johnston E, Viktrup L. Efficacy and safety of tanezumab, NSAIDs, and placebo in patients with moderate to severe hip or knee osteoarthritis and a history of depression, anxiety, or insomnia: post-hoc analysis of phase 3 trials. Curr Med Res Opin. 2022 Nov;38(11):1909-1922. doi: 10.1080/03007995.2022.2113689. Epub 2022 Aug 28.

Results Reference

derived

PubMed Identifier

35960482

Citation

Schnitzer TJ, Bonfanti G, Atkinson J, Donevan S, Viktrup L, Barroso J, Whalen E, Edwards RA. Characterizing 16-Week Responder Profiles Using Group-Based Trajectory Modeling in Over 4300 Clinical Trial Participants Receiving Pharmaceutical Treatment for Moderate to Severe Osteoarthritis. Adv Ther. 2022 Oct;39(10):4742-4756. doi: 10.1007/s12325-022-02290-3. Epub 2022 Aug 12.

Results Reference

derived

PubMed Identifier

35232805

Citation

Conaghan PG, Dworkin RH, Schnitzer TJ, Berenbaum F, Bushmakin AG, Cappelleri JC, Viktrup L, Abraham L. WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. J Rheumatol. 2022 Jun;49(6):615-621. doi: 10.3899/jrheum.210543. Epub 2022 Mar 1.

Results Reference

derived

PubMed Identifier

35105318

Citation

Conaghan PG, Abraham L, Viktrup L, Cislo P. Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis. BMC Musculoskelet Disord. 2022 Feb 1;23(1):106. doi: 10.1186/s12891-022-05029-x.

Results Reference

derived

PubMed Identifier

34626502

Citation

Berenbaum F, Schnitzer T, Kivitz A, Viktrup L, Johnston E, Yang R, Whalen E, Tive L, Semel D. Gender, age, disease severity, body mass index and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo-controlled trials. Int J Clin Pract. 2021 Dec;75(12):e14975. doi: 10.1111/ijcp.14975. Epub 2021 Oct 21.

Results Reference

derived

PubMed Identifier

33973384

Citation

Berenbaum F, Schnitzer TJ, Kivitz AJ, Viktrup L, Hickman A, Pixton G, Brown MT, Davignon I, West CR. General Safety and Tolerability of Subcutaneous Tanezumab for Osteoarthritis: A Pooled Analysis of Three Randomized, Placebo-Controlled Trials. Arthritis Care Res (Hoboken). 2022 Jun;74(6):918-928. doi: 10.1002/acr.24637. Epub 2022 Mar 25.

Results Reference

derived

PubMed Identifier

32252976

Citation

Schnitzer TJ, Khan A, Bessette L, Davignon I, Brown MT, Pixton G, Prucka WR, Tive L, Viktrup L, West CR. Onset and maintenance of efficacy of subcutaneous tanezumab in patients with moderate to severe osteoarthritis of the knee or hip: A 16-week dose-titration study. Semin Arthritis Rheum. 2020 Jun;50(3):387-393. doi: 10.1016/j.semarthrit.2020.03.004. Epub 2020 Mar 19.

Results Reference

derived

PubMed Identifier

31265100

Citation

Schnitzer TJ, Easton R, Pang S, Levinson DJ, Pixton G, Viktrup L, Davignon I, Brown MT, West CR, Verburg KM. Effect of Tanezumab on Joint Pain, Physical Function, and Patient Global Assessment of Osteoarthritis Among Patients With Osteoarthritis of the Hip or Knee: A Randomized Clinical Trial. JAMA. 2019 Jul 2;322(1):37-48. doi: 10.1001/jama.2019.8044.

Results Reference

derived

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=A4091056

Description

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Learn more about this trial

Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

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