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Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Investigational Medical Product (IMP) administered in parent study
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Personally signed and dated informed consent document.
  • Randomized and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.
  • Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab study.
  • Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

- None.

Sites / Locations

  • Central Alabama Research
  • Alabama Clinical Therapeutics, LLC
  • Alabama Orthopaedic Surgeons
  • Cahaba Research Inc.
  • Noble Clinical Research
  • Baptist Health Center for Clinical Research
  • Advanced Research Center, Inc.
  • Hope Clinical Research
  • Marvel Clinical Research, LLC
  • Advances in Medicine
  • Clinical Trials Research
  • California Research Foundation
  • CITrials
  • Stamford Therapeutics Consortium
  • JEM Research Institute
  • Orthopedic Research Institute
  • Orthopaedic Associates of West Florida
  • Clinical Neuroscience Solutions, Inc.
  • Clintex Research Group
  • Renstar Medical Research
  • American Family Medical
  • Sunshine Research Center
  • Gulfcoast Research Institute, LLC
  • Kennedy White Orthopaedic Center
  • Stedman Clinical Trials
  • Masters of Clinical Research, Inc.
  • North Georgia Clinical Research
  • North Georgia Internal Medicine
  • Injury Care Research
  • Chicago Clinical Research Institute, Inc.
  • Northwestern University
  • Professional Research Network of Kansas, LLC
  • Best Clinical Trials, LLC
  • George Stanley Walker, MD
  • Great Lakes Research Group, Incorporated
  • Orthopaedic Associates of Michigan, PC
  • Physician Research Collaboration, LLC
  • Drug Trials America
  • Remington-Davis, Incorporated
  • Optimed Research LTD
  • AC Clinical Research
  • Founders Research Corporation
  • Abigail R. Neiman, MD, PA
  • Advances In Health
  • Mercury Clinical Research, Inc.
  • BI Research Center
  • ClinRx Research
  • DCT - Stone Oak, LLC dba Discovery Clinical Trials
  • Mercury Clinical Research
  • Spectrum Medical, Inc.
  • Northwest Clinical Research Center
  • CMAX Clinical Research Pty Ltd
  • Dawson Road Medical Centre
  • Rebecca Medical Associates
  • Recherche Clinique Sigma inc
  • Centre de recherche Saint-Louis
  • Rheumazentrum Prof. Dr. med Gunther Neeck
  • Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly
  • Azienda Ospedaliero-Universitaria E Policlinico Umberto I
  • Omuro Orthopedic Clinic
  • Nakajo Orthopedic Clinic
  • Marunouchi Hospital
  • National Hospital Organization Osaka Minami Medical Center
  • Osaka University Hospital
  • Saules seimos medicinos centras
  • South Pacific Clinical Trials
  • Star Unit, North Shore Hospital, Waitemata District Health Board
  • Southern Clinical Trials- Waitemata Ltd
  • Clinical Horizons NZ Ltd
  • Hospital Conde de Bertiandos
  • Medical Technologies Ltd.
  • Institute of Rheumatology
  • Kompan, s.r.o.
  • Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o.
  • Instituto de Ciencias Medicas
  • Hospital del Mar
  • Ladulaas Kliniska Studier
  • ProbarE I Lund AB
  • ProbarE i Stockholm AB

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cohort 1

Arm Description

long-term observational study of subjects from tanezumab parent study

Outcomes

Primary Outcome Measures

Number of Participants With Surgeon's Assessment of Procedural Difficulty
Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: "taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications." Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24
SAPS contained four questions; How satisfied are you with the 1) results of your surgery 2) results of surgery for improving pain 3) results of surgery for improving ability to do home or yard work, and 4) results of surgery for improving your ability to do recreational activities. Items scored on a 4-point Likert scale with response of 'very satisfied' (100 points), 'somewhat satisfied' (75 points), 'somewhat dissatisfied' (50 points), and 'very dissatisfied' (25 points). The scale score calculated as mean of the scores of individual items, ranging from 25 to 100, with higher scores indicating greater satisfaction. Here, number of participants are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Participants may have been counted more than once if they had TJR surgery in more than one joint.
Number of Participants With Post-Surgical Complications Upto Week 24
Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24
Participants were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Participants, who responded as yes have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24
Participants responded with a yes or no to the following question ''are you participating in physical rehabilitation activities related to your replaced joint''. Participants responded with a yes, have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24
Participants assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
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 (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
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 OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the replaced/to be replaced index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
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 OA. 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 OA in replaced/ to be replaced index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24
SPADI: self-administered questionnaire to measure pain and disability associated with shoulder pathology in participants with shoulder pain. It consists of two dimensions pain and function. Pain dimension:5 questions regarding severity of pain, scores ranged from 0=no pain to 10=worst pain imaginable, higher scores indicated extreme pain. Functional activities:8 questions to measure degree of difficulty with various activities of daily living that require upper extremity use, scores ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as the sum of non-missing scores divided by the maximum possible score (50 [for pain] and 80 [for disability]) multiplied by 100. A total score was calculated as the mean of two dimensions, ranged from 0=best to 100=worst, higher scores indicated worsening of condition.
Number of Participants Who Used Concomitant Analgesic Medications

Secondary Outcome Measures

Full Information

First Posted
November 11, 2015
Last Updated
July 6, 2020
Sponsor
Pfizer
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02674386
Brief Title
Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Official Title
A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 23, 2016 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. The study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. There will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet).
Detailed Description
A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Other
Arm Description
long-term observational study of subjects from tanezumab parent study
Intervention Type
Drug
Intervention Name(s)
Investigational Medical Product (IMP) administered in parent study
Intervention Description
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
Primary Outcome Measure Information:
Title
Number of Participants With Surgeon's Assessment of Procedural Difficulty
Description
Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: "taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications." Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time Frame
Day 1
Title
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24
Description
SAPS contained four questions; How satisfied are you with the 1) results of your surgery 2) results of surgery for improving pain 3) results of surgery for improving ability to do home or yard work, and 4) results of surgery for improving your ability to do recreational activities. Items scored on a 4-point Likert scale with response of 'very satisfied' (100 points), 'somewhat satisfied' (75 points), 'somewhat dissatisfied' (50 points), and 'very dissatisfied' (25 points). The scale score calculated as mean of the scores of individual items, ranging from 25 to 100, with higher scores indicating greater satisfaction. Here, number of participants are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time Frame
Week 24
Title
Number of Participants With Post-Surgical Complications Upto Week 24
Description
Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time Frame
Baseline up to Week 24
Title
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24
Description
Participants were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Participants, who responded as yes have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time Frame
Baseline up to Week 24
Title
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24
Description
Participants responded with a yes or no to the following question ''are you participating in physical rehabilitation activities related to your replaced joint''. Participants responded with a yes, have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time Frame
Baseline up to Week 24
Title
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24
Description
Participants assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time Frame
Baseline, Week 24
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 (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness 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 OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the replaced/to be replaced index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time Frame
Baseline, Week 24
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 OA. 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 OA in replaced/ to be replaced index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24
Description
SPADI: self-administered questionnaire to measure pain and disability associated with shoulder pathology in participants with shoulder pain. It consists of two dimensions pain and function. Pain dimension:5 questions regarding severity of pain, scores ranged from 0=no pain to 10=worst pain imaginable, higher scores indicated extreme pain. Functional activities:8 questions to measure degree of difficulty with various activities of daily living that require upper extremity use, scores ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as the sum of non-missing scores divided by the maximum possible score (50 [for pain] and 80 [for disability]) multiplied by 100. A total score was calculated as the mean of two dimensions, ranged from 0=best to 100=worst, higher scores indicated worsening of condition.
Time Frame
Baseline, Week 24
Title
Number of Participants Who Used Concomitant Analgesic Medications
Time Frame
Baseline up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Personally signed and dated informed consent document. Randomized and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study. Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab study. Willing and able to comply with scheduled visits and other study procedures. Exclusion Criteria: - None.
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
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
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
Noble Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
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
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Marvel Clinical Research, LLC
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Advances in Medicine
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Clinical Trials Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
CITrials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Orthopedic Research Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Orthopaedic Associates of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clintex Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
American Family Medical
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Sunshine Research Center
City
Opa-locka
State/Province
Florida
ZIP/Postal Code
33054
Country
United States
Facility Name
Gulfcoast Research Institute, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232-6028
Country
United States
Facility Name
Kennedy White Orthopaedic Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Masters of Clinical Research, Inc.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
North Georgia Internal Medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Injury Care Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
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
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
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
Best Clinical Trials, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
George Stanley Walker, MD
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Great Lakes Research Group, Incorporated
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Orthopaedic Associates of Michigan, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Remington-Davis, Incorporated
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Optimed Research LTD
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
AC Clinical Research
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
Founders Research Corporation
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Abigail R. Neiman, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Advances In Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mercury Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
BI Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
ClinRx Research
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
DCT - Stone Oak, LLC dba Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Mercury Clinical Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Spectrum Medical, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
CMAX Clinical Research Pty Ltd
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Dawson Road Medical Centre
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 1B1
Country
Canada
Facility Name
Rebecca Medical Associates
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6K 1J6
Country
Canada
Facility Name
Recherche Clinique Sigma inc
City
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
Facility Name
Centre de recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Rheumazentrum Prof. Dr. med Gunther Neeck
City
Bad Doberan
ZIP/Postal Code
18209
Country
Germany
Facility Name
Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Azienda Ospedaliero-Universitaria E Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Omuro Orthopedic Clinic
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-0976
Country
Japan
Facility Name
Nakajo Orthopedic Clinic
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-0862
Country
Japan
Facility Name
Marunouchi Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8601
Country
Japan
Facility Name
National Hospital Organization Osaka Minami Medical Center
City
Kawachinagano
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saules seimos medicinos centras
City
Kaunas
ZIP/Postal Code
LT-49449
Country
Lithuania
Facility Name
South Pacific Clinical Trials
City
Auckland
ZIP/Postal Code
0610
Country
New Zealand
Facility Name
Star Unit, North Shore Hospital, Waitemata District Health Board
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Southern Clinical Trials- Waitemata Ltd
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Clinical Horizons NZ Ltd
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Hospital Conde de Bertiandos
City
Ponte de Lima
State/Province
Viana DO Castelo
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Medical Technologies Ltd.
City
Saint-Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Kompan, s.r.o.
City
Dolny Kubin
ZIP/Postal Code
02601
Country
Slovakia
Facility Name
Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o.
City
Pruske
ZIP/Postal Code
018 52
Country
Slovakia
Facility Name
Instituto de Ciencias Medicas
City
Alicante
ZIP/Postal Code
03004
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Ladulaas Kliniska Studier
City
Boras, Sweden
ZIP/Postal Code
SE-506 30
Country
Sweden
Facility Name
ProbarE I Lund AB
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Facility Name
ProbarE i Stockholm AB
City
Stockholm
ZIP/Postal Code
111 37
Country
Sweden

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
34043229
Citation
Mont MA, Carrino JA, Nemeth MA, Burr A, Yamabe T, Viktrup L, Brown MT, West CR, Verburg KM. Postoperative Outcome of Patients Who Underwent Total Joint Replacement During the Tanezumab Phase 3 Osteoarthritis Development Program: A 24-Week Observational Study. Surg Technol Int. 2021 May 20;38:467-477. doi: 10.52198/21.STI.38.OS1439.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=A4091064
Description
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Learn more about this trial

Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement

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