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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip
• Intervention / Treatment: Other: Placebo; Biological: Tanezumab 2.5 mg; Biological: Tanezumab 2.5mg/5mg

• Study Type: Interventional
• Enrollment (Actual): 698
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • Quebec, Canada, G1V 3M7
    • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
  • Quebec, Canada, G1G 3Y8
    • Recherche Clinique Sigma inc
  • Quebec, Canada, G1S 2L6
    • Diex Recherche Quebec Inc.
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
    • Burlington, Ontario, Canada, L7R 1A4
      • Manna Research Inc. (Burlington south)
    • Guelph, Ontario, Canada, N1H 1B1
      • Dawson Road Medical Centre
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Adachi Medicine Professional Corporation
    • Kitchener, Ontario, Canada, N2M 5N6
      • K-W Musculoskeletal Research Inc.
    • London, Ontario, Canada, N6G 2M1
      • Western Center for Public Health and Family Medicine
    • Mississauga, Ontario, Canada, L4V 1P1
      • Malton Medical Centre
    • Oakville, Ontario, Canada, L6K 1J6
      • Rebecca Medical Associates
    • Oshawa, Ontario, Canada, L1H 1G6
      • King Street Medical Clinic
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group
  • Quebec
    • Montreal, Quebec, Canada, H2Y 1S1
      • Diex Recheche Montreal, Inc.
    • Quebec City, Quebec, Canada, G3K 2P8
      • ALPHA Recherche Clinique
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Research Sherbrooke Inc.
• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Puerto Rico Medical Research Inc.
  • San Juan, Puerto Rico, 00918
    • Mindful Medical Research
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Cahaba Research, Inc.
    • Birmingham, Alabama, United States, 35235
      • Alabama Orthopaedic Surgeons
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
    • Surprise, Arizona, United States, 85374
      • Clinical Research Institute of Arizona, LLC
    • Tucson, Arizona, United States, 85724
      • University of Arizona Clinical and Translational Science Research Center
    • Tucson, Arizona, United States, 85714
      • Tucson Orthopaedic Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc
    • Covina, California, United States, 91722
      • Medvin Clinical Research
    • Fullerton, California, United States, 92835
      • St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
    • Irvine, California, United States, 92614
      • Irvine Center for Clinical Research
    • Irvine, California, United States, 92618
      • Robert L Freed, M.D., F.A.C.R / Clinical Interventions Research Institute
    • North Hollywood, California, United States, 91606
      • Providence Clinical Research
    • San Diego, California, United States, 92123
      • California Research Foundation
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials, Inc.
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • New England Research Associates, LLC
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Clinical Physiology Associates
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc.
    • Miami, Florida, United States, 33175
      • New Horizon Research Center
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research Institute, LLC
    • Miami, Florida, United States, 33135
      • South Florida Research Center, Inc.
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Ormond Beach, Florida, United States, 32174
      • Ormond Beach Clinical Research
    • Tamarac, Florida, United States, 33321
      • Phoenix Clinical Research, LLC
    • The Villages, Florida, United States, 32162
      • Bioclinica Research
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education (CARE)
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
    • Chicago, Illinois, United States, 60607
      • Chicago Clinical Research Institute, Inc.
    • Chicago, Illinois, United States, 60602
      • Medex Healthcare Research Inc
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • Investigators Research Group, Llc
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trial Services, Inc.
  • Kansas
    • Wichita, Kansas, United States, 67205-1138
      • Professional Research Network of Kansas, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • George Stanley Walker, MD
  • Massachusetts
    • North Attleboro, Massachusetts, United States, 02760
      • Tristan Medical Enterprises, PC dba Regeneris Medical
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Michigan Orthopaedic & Spine Surgeons
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Arthritis and Osteoporosis Treatment and Research Center
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Office of Stephen H. Miller, M.D.
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Arthritis and Osteoporosis Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Clinical Research & Osteoporosis Center, Inc.
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Clinical Research Center, LLC
  • Ohio
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
    • Tiffin, Ohio, United States, 44883
      • AC Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73119
      • Hillcrest Clinical Research
    • Oklahoma City, Oklahoma, United States, 73109
      • NPC Research
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • University Orthopedics Center
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Palmetto Clinical Trial Services, LLC
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Nashville, Tennessee, United States, 37211
      • Quality Medical Research
  • Texas
    • Arlington, Texas, United States, 76012
      • KRK Medical Research
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc
    • Baytown, Texas, United States, 77521
      • Urgent Care MD's
    • Dallas, Texas, United States, 75231
      • Arthritis Care and Diagnostic Center
    • Fort Worth, Texas, United States, 76117
      • T&R Clinic, PA
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc.
    • Houston, Texas, United States, 77084
      • BI Research Center
    • Plano, Texas, United States, 75024
      • The Pain Relief Center
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Center for Arthritis and Rheumatic Diseases
    • Danville, Virginia, United States, 24541
      • Spectrum Medical, Inc
    • Richmond, Virginia, United States, 23294
      • National Clinical Research - Richmond, Inc
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo administered subcutaneously at day 0 and week 8	Other: Placebo; 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.
Experimental: Tanezumab 2.5 mg; tanezumab 2.5 mg administered subcutaneously at day 0 and week 8	Biological: Tanezumab 2.5 mg; 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.
Experimental: Tanezumab 2.5mg/5mg; tanezumab 2.5 mg administered subcutaneously at day 0 and tanezumab 5 mg administered subcutaneously at week 8	Biological: Tanezumab 2.5mg/5mg; Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.; Other Names: Titration Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 16
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.	Baseline, Week 16
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.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Weeks 2, 4, 8 and 12
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.	Baseline, Week 24
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.	Baseline, Weeks 2, 4, 8 and 12
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.	Baseline, Week 24
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12	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).	Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24	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 worse condition.	Baseline, 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).	Weeks 2, 4, 8, 12, 16 and 24
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.	Week 2, 4, 8, 12, 16 and 24
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.	Baseline to Week 16
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.	Weeks 2, 4, 8, 12, 16 and 24
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.	Baseline to Week 16
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.	Weeks 2, 4, 8, 12, 16 and 24
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.	Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16
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.	Baseline, Weeks 20 and 24
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.	Baseline, Weeks 2, 4, 8, 12 and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness 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. 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.	Baseline, 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.	Baseline, Weeks 2, 4, 8, 12 and 16
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.	Baseline, Week 24
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.	Baseline, Weeks 2, 4, 8, 12 and 16
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.	Baseline, Week 24
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.	Baseline, Weeks 2, 4, 8, 12 and 16
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.	Baseline, Week 24
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.	Baseline
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16	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.	Baseline and 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.	Baseline, Weeks 8 and 16
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.	Baseline, Weeks 8 and 16
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.	Baseline, Weeks 24 and 40
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).	Baseline, Weeks 24 and 40
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.	Baseline, Weeks 24 and 40
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.	Baseline, Weeks 24 and 40
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.	Baseline, Weeks 24 and 40
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.	Baseline, Weeks 24 and 40
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.	Baseline, Weeks 24 and 40
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.	Baseline, Weeks 24 and 40
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.	Baseline up to Week 16
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.	Baseline up to Week 16
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.	Week 2, 4, 8, 12 and 16
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.	Week 24
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.	Week 2, 4, 8, 12, 16
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.	Week 24
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.	Week 2, 4, 8, 12, 16
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.	Baseline up to Week 40
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.	Baseline up to Week 40
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.	Baseline up to Week 40
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.	Baseline up to Week 40
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).	Baseline, Weeks 2, 4, 8, 12, 16, 24, 40
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40	Heart rate was measured at sitting position.	Baseline, Weeks 2, 4, 8, 12, 16, 24 and 40
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.	Baseline, Weeks 16, 40
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40		Baseline, 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.	Baseline up to Week 40
Percentage of Participants With Total Joint Replacements	Percentage of participants who underwent total knee, hip or shoulder joint replacement surgery.	Baseline up to Week 40
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.	Baseline, Weeks 2, 4, 8,12,16, 24 and 40
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.	Baseline up to Week 40
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.	Baseline, Weeks 24 and 40
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.	Baseline, Weeks 8,16, 24 and 40

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2016
• Primary Completion (Actual): December 5, 2017
• Study Completion (Actual): May 14, 2018

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis of the hip; tanezumab; osteoarthritis of the knee; nerve growth factor inhibitor
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tanezumab
• Other Study ID Numbers: A4091056; 2013-002222-23 (EudraCT Number); OA TITRATION STUDY (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No