Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
3 other identifiers
interventional
154
14 countries
76
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2016
Typical duration for phase_3
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2016
CompletedStudy Start
First participant enrolled
August 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2019
CompletedResults Posted
Study results publicly available
July 30, 2020
CompletedJuly 30, 2020
July 1, 2020
2.9 years
November 11, 2015
July 6, 2020
July 6, 2020
Conditions
Outcome Measures
Primary Outcomes (11)
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.
Day 1
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.
Week 24
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.
Baseline up to Week 24
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.
Baseline up to Week 24
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.
Baseline up to Week 24
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.
Baseline, Week 24
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.
Baseline, Week 24
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.
Baseline, Week 24
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.
Baseline, Week 24
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.
Baseline, Week 24
Number of Participants Who Used Concomitant Analgesic Medications
Baseline up to Week 24
Study Arms (1)
Cohort 1
OTHERlong-term observational study of subjects from tanezumab parent study
Interventions
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Eli Lilly and Companycollaborator
Study Sites (79)
Central Alabama Research
Birmingham, Alabama, 35209, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Alabama Orthopaedic Surgeons
Birmingham, Alabama, 35235, United States
Cahaba Research Inc.
Birmingham, Alabama, 35242, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Marvel Clinical Research, LLC
Huntington Beach, California, 92647, United States
Advances in Medicine
Palm Desert, California, 92260, United States
Clinical Trials Research
Sacramento, California, 95821, United States
California Research Foundation
San Diego, California, 92123, United States
CITrials
Santa Ana, California, 92705, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Orthopedic Research Institute
Boynton Beach, Florida, 33472, United States
Orthopaedic Associates of West Florida
Clearwater, Florida, 33756, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Clintex Research Group
Miami, Florida, 33135, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
American Family Medical
Ocala, Florida, 34471, United States
Sunshine Research Center
Opa-locka, Florida, 33054, United States
Gulfcoast Research Institute, LLC
Sarasota, Florida, 34232-6028, United States
Kennedy White Orthopaedic Center
Sarasota, Florida, 34232, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Masters of Clinical Research, Inc.
Augusta, Georgia, 30909, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
North Georgia Internal Medicine
Woodstock, Georgia, 30189, United States
Injury Care Research
Boise, Idaho, 83713, United States
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, 60607, United States
Northwestern University
Chicago, Illinois, 60611, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67205-1138, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115, United States
George Stanley Walker, MD
New Orleans, Louisiana, 70115, United States
Great Lakes Research Group, Incorporated
Bay City, Michigan, 48706, United States
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, 49525, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Remington-Davis, Incorporated
Columbus, Ohio, 43215, United States
Optimed Research LTD
Columbus, Ohio, 43235, United States
AC Clinical Research
Tiffin, Ohio, 44883, United States
Founders Research Corporation
Philadelphia, Pennsylvania, 19114, United States
Abigail R. Neiman, MD, PA
Houston, Texas, 77024, United States
Advances In Health
Houston, Texas, 77030, United States
Mercury Clinical Research, Inc.
Houston, Texas, 77036, United States
BI Research Center
Houston, Texas, 77084, United States
ClinRx Research
Richardson, Texas, 75080, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Mercury Clinical Research
Webster, Texas, 77598, United States
Spectrum Medical, Inc.
Danville, Virginia, 24541, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000, Australia
Dawson Road Medical Centre
Guelph, Ontario, N1H 1B1, Canada
Rebecca Medical Associates
Oakville, Ontario, L6K 1J6, Canada
Recherche Clinique Sigma inc
Québec, Quebec, G1G 3Y8, Canada
Centre de recherche Saint-Louis
Québec, Quebec, G1W 4R4, Canada
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, 18209, Germany
Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly
Szekszárd, 7100, Hungary
Azienda Ospedaliero-Universitaria E Policlinico Umberto I
Rome, 00161, Italy
Omuro Orthopedic Clinic
Himeji, Hyōgo, 670-0976, Japan
Nakajo Orthopedic Clinic
Sendai, Miyagi, 983-0862, Japan
Marunouchi Hospital
Matsumoto, Nagano, 390-8601, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, 586-8521, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Saules seimos medicinos centras
Kaunas, LT-49449, Lithuania
South Pacific Clinical Trials
Auckland, 0610, New Zealand
Star Unit, North Shore Hospital, Waitemata District Health Board
Auckland, 0622, New Zealand
Southern Clinical Trials- Waitemata Ltd
Auckland, 0626, New Zealand
Clinical Horizons NZ Ltd
Tauranga, 3112, New Zealand
Hospital Conde de Bertiandos
Ponte de Lima, Viana do Castelo District, 4990-041, Portugal
Medical Technologies Ltd.
Saint Petersburg, 191025, Russia
Institute of Rheumatology
Belgrade, 11000, Serbia
Kompan, s.r.o.
Dolný Kubín, 02601, Slovakia
Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o.
Pruské, 018 52, Slovakia
Instituto de Ciencias Medicas
Alicante, 03004, Spain
Hospital del Mar
Barcelona, 08003, Spain
Ladulaas Kliniska Studier
Boras, Sweden, SE-506 30, Sweden
ProbarE I Lund AB
Lund, 222 22, Sweden
ProbarE i Stockholm AB
Stockholm, 111 37, Sweden
Related Publications (1)
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.
PMID: 34043229DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2015
First Posted
February 4, 2016
Study Start
August 23, 2016
Primary Completion
July 15, 2019
Study Completion
July 15, 2019
Last Updated
July 30, 2020
Results First Posted
July 30, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.