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

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Investigational Medical Product (IMP) administered in parent study

Detailed Description

A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX Clinical Research Pty Ltd
• Canada
  • Quebec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • Quebec, Canada, G1G 3Y8
    • Recherche Clinique Sigma Inc
  • Ontario
    • Guelph, Ontario, Canada, N1H 1B1
      • Dawson Road Medical Centre
    • Oakville, Ontario, Canada, L6K 1J6
      • Rebecca Medical Associates
• Germany
  • Bad Doberan, Germany, 18209
    • Rheumazentrum Prof. Dr. med Gunther Neeck
• Hungary
  • Szekszard, Hungary, 7100
    • Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly
• Italy
  • Rome, Italy, 00161
    • Azienda Ospedaliero-Universitaria E Policlinico Umberto I
• Japan
  • Hyogo
    • Himeji, Hyogo, Japan, 670-0976
      • Omuro Orthopedic Clinic
  • Miyagi
    • Sendai, Miyagi, Japan, 983-0862
      • Nakajo Orthopedic Clinic
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8601
      • Marunouchi Hospital
  • Osaka
    • Kawachinagano, Osaka, Japan, 586-8521
      • National Hospital Organization Osaka Minami Medical Center
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
• Lithuania
  • Kaunas, Lithuania, LT-49449
    • Saules Seimos Medicinos Centras
• New Zealand
  • Auckland, New Zealand, 0610
    • South Pacific Clinical Trials
  • Auckland, New Zealand, 0622
    • Star Unit, North Shore Hospital, Waitemata District Health Board
  • Auckland, New Zealand, 0626
    • Southern Clinical Trials- Waitemata Ltd
  • Tauranga, New Zealand, 3112
    • Clinical Horizons NZ Ltd
• Portugal
  • Viana DO Castelo
    • Ponte de Lima, Viana DO Castelo, Portugal, 4990-041
      • Hospital Conde de Bertiandos
• Russian Federation
  • Saint-Petersburg, Russian Federation, 191025
    • Medical Technologies Ltd.
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
• Slovakia
  • Dolny Kubin, Slovakia, 02601
    • Kompan, s.r.o.
  • Pruske, Slovakia, 018 52
    • Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o.
• Spain
  • Alicante, Spain, 03004
    • Instituto de Ciencias Médicas
  • Barcelona, Spain, 08003
    • Hospital del Mar
• Sweden
  • Boras, Sweden, Sweden, SE-506 30
    • Ladulaas Kliniska Studier
  • Lund, Sweden, 222 22
    • ProbarE i Lund AB
  • Stockholm, Sweden, 111 37
    • ProbarE i Stockholm AB
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Birmingham, Alabama, United States, 35209
      • Central Alabama Research
    • Birmingham, Alabama, United States, 35242
      • Cahaba Research Inc.
    • Birmingham, Alabama, United States, 35235
      • Alabama Orthopaedic Surgeons
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research, LLC
    • Palm Desert, California, United States, 92260
      • Advances in Medicine
    • Sacramento, California, United States, 95821
      • Clinical Trials Research
    • San Diego, California, United States, 92123
      • California Research Foundation
    • Santa Ana, California, United States, 92705
      • CiTrials
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Boynton Beach, Florida, United States, 33472
      • Orthopedic Research Institute
    • Clearwater, Florida, United States, 33756
      • Orthopaedic Associates of West Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Miami, Florida, United States, 33135
      • Clintex Research Group
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Ocala, Florida, United States, 34471
      • American Family Medical
    • Opa-locka, Florida, United States, 33054
      • Sunshine Research Center
    • Sarasota, Florida, United States, 34232
      • Kennedy White Orthopaedic Center
    • Sarasota, Florida, United States, 34232-6028
      • Gulfcoast Research Institute, LLC
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Masters of Clinical Research, Inc.
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
    • Woodstock, Georgia, United States, 30189
      • North Georgia Internal Medicine
  • Idaho
    • Boise, Idaho, United States, 83713
      • Injury Care Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60607
      • Chicago Clinical Research Institute, Inc.
  • Kansas
    • Wichita, Kansas, United States, 67205-1138
      • Professional Research Network of Kansas, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Best Clinical Trials, LLC
    • New Orleans, Louisiana, United States, 70115
      • George Stanley Walker, MD
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Incorporated
    • Grand Rapids, Michigan, United States, 49525
      • Orthopaedic Associates of Michigan, PC
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
  • Ohio
    • Columbus, Ohio, United States, 43235
      • Optimed Research Ltd
    • Columbus, Ohio, United States, 43215
      • Remington-Davis, Incorporated
    • Tiffin, Ohio, United States, 44883
      • AC Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Founders Research Corporation
  • Texas
    • Houston, Texas, United States, 77084
      • BI Research Center
    • Houston, Texas, United States, 77030
      • Advances In Health
    • Houston, Texas, United States, 77024
      • Abigail R. Neiman, MD, PA
    • Houston, Texas, United States, 77036
      • Mercury Clinical Research, Inc.
    • Richardson, Texas, United States, 75080
      • ClinRx Research
    • San Antonio, Texas, United States, 78258
      • DCT - Stone Oak, LLC dba Discovery Clinical Trials
    • Webster, Texas, United States, 77598
      • Mercury Clinical Research
  • Virginia
    • Danville, Virginia, United States, 24541
      • Spectrum Medical, 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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cohort 1; long-term observational study of subjects from tanezumab parent study	Drug: Investigational Medical Product (IMP) administered in parent study; IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Eli Lilly and Company

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2016
• Primary Completion (ACTUAL): July 15, 2019
• Study Completion (ACTUAL): July 15, 2019

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (ESTIMATE): February 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: A4091064; 2013-002549-12 (EUDRACT_NUMBER); TJR FOLLOW-UP (OTHER: 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