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Trial record 1 of 1 for:    NCT02674386
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Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement

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ClinicalTrials.gov Identifier: NCT02674386
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 11, 2015
First Posted Date  ICMJE February 4, 2016
Results First Submitted Date  ICMJE July 6, 2020
Results First Posted Date  ICMJE July 30, 2020
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE August 23, 2016
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • Number of Participants With Surgeon's Assessment of Procedural Difficulty [ Time Frame: Day 1 ]
    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 [ Time Frame: 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 [ Time Frame: Baseline up to 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 [ Time Frame: Baseline up to 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 [ Time Frame: Baseline up to 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline up to Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
  • Surgeon's Assessment of Procedural Difficulty [ Time Frame: Day of Surgery ]
    Percentage of surgeries assessed as uneventful, minor complications or major complications.
  • Subject's overall satisfaction with surgery as assessed by the Self-Administered Patient Satisfaction (SAPS) Scale [ Time Frame: Week 24 ]
    Percentage of subjects satisfied vs. unsatisfied with their total joint replacement at Week 24
  • Post-surgical complications [ Time Frame: up to Week 24 ]
    Percentage of subjects with a post-surgical complication(s) up to Week 24.
  • Additional or Corrective Procedures [ Time Frame: up to Week 24 ]
    Percentage of subjects with additional or corrective procedures related to their total joint replacement up to Week 24.
  • Physical Rehabilitation Activities [ Time Frame: up to Week 24 ]
    Percentage of subjects participating in physical rehabilitation activities related to the replaced joint up to Week 24.
  • Average Pain [ Time Frame: Change from baseline to Week 24 ]
    Change from Baseline to Week 24 in average pain in the replaced joint.[Assessed on an 11-point numeric rating scale.]
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Change from baseline to Week 24 ]
    Change from Baseline to Week 24 in WOMAC Pain, Stiffness and Physical Function subscales in the replaced joint (Subjects undergoing total hip or knee replacement surgery only).
  • Shoulder Pain and Disability Index (SPADI) [ Time Frame: Change from baseline to Week 24 ]
    Change from Baseline to Week 24 in the SPADI in the replaced shoulder (subjects undergoing total shoulder replacement surgery only).
  • Concomitant Analgesic Use [ Time Frame: Up to Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Official Title  ICMJE A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Osteoarthritis
Intervention  ICMJE 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.
Study Arms  ICMJE Cohort 1
long-term observational study of subjects from tanezumab parent study
Intervention: Drug: Investigational Medical Product (IMP) administered in parent study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2019)
154
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2016)
250
Actual Study Completion Date  ICMJE July 15, 2019
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Hungary,   Italy,   Japan,   Lithuania,   New Zealand,   Portugal,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden,   United States
Removed Location Countries Austria,   Brazil,   Bulgaria,   Colombia,   Croatia,   Finland,   France,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Puerto Rico,   Romania,   Taiwan,   Ukraine,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02674386
Other Study ID Numbers  ICMJE A4091064
2013-002549-12 ( EudraCT Number )
TJR FOLLOW-UP ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP