Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02674386
Registration number
NCT02674386
Ethics application status
Date submitted
11/11/2015
Date registered
4/02/2016
Date last updated
30/07/2020
Titles & IDs
Public title
Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Query!
Scientific title
A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
Query!
Secondary ID [1]
0
0
2013-002549-12
Query!
Secondary ID [2]
0
0
A4091064
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Investigational Medical Product (IMP) administered in parent study
Other: Cohort 1 - long-term observational study of subjects from tanezumab parent study
Treatment: Drugs: 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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Surgeon's Assessment of Procedural Difficulty
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Day 1
Query!
Primary outcome [2]
0
0
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 24
Query!
Primary outcome [3]
0
0
Number of Participants With Post-Surgical Complications Upto Week 24
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline up to Week 24
Query!
Primary outcome [4]
0
0
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline up to Week 24
Query!
Primary outcome [5]
0
0
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline up to Week 24
Query!
Primary outcome [6]
0
0
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline, Week 24
Query!
Primary outcome [7]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline, Week 24
Query!
Primary outcome [8]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline, Week 24
Query!
Primary outcome [9]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline, Week 24
Query!
Primary outcome [10]
0
0
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline, Week 24
Query!
Primary outcome [11]
0
0
Number of Participants Who Used Concomitant Analgesic Medications
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Baseline up to Week 24
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- None.
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
23/08/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/07/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
154
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
CMAX Clinical Research Pty Ltd - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kansas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Michigan
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Texas
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Virginia
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Ontario
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Quebec
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Bad Doberan
Query!
Country [23]
0
0
Hungary
Query!
State/province [23]
0
0
Szekszard
Query!
Country [24]
0
0
Italy
Query!
State/province [24]
0
0
Rome
Query!
Country [25]
0
0
Japan
Query!
State/province [25]
0
0
Hyogo
Query!
Country [26]
0
0
Japan
Query!
State/province [26]
0
0
Miyagi
Query!
Country [27]
0
0
Japan
Query!
State/province [27]
0
0
Nagano
Query!
Country [28]
0
0
Japan
Query!
State/province [28]
0
0
Osaka
Query!
Country [29]
0
0
Lithuania
Query!
State/province [29]
0
0
Kaunas
Query!
Country [30]
0
0
New Zealand
Query!
State/province [30]
0
0
Auckland
Query!
Country [31]
0
0
New Zealand
Query!
State/province [31]
0
0
Tauranga
Query!
Country [32]
0
0
Portugal
Query!
State/province [32]
0
0
Viana DO Castelo
Query!
Country [33]
0
0
Russian Federation
Query!
State/province [33]
0
0
Saint-Petersburg
Query!
Country [34]
0
0
Serbia
Query!
State/province [34]
0
0
Belgrade
Query!
Country [35]
0
0
Slovakia
Query!
State/province [35]
0
0
Dolny Kubin
Query!
Country [36]
0
0
Slovakia
Query!
State/province [36]
0
0
Pruske
Query!
Country [37]
0
0
Spain
Query!
State/province [37]
0
0
Alicante
Query!
Country [38]
0
0
Spain
Query!
State/province [38]
0
0
Barcelona
Query!
Country [39]
0
0
Sweden
Query!
State/province [39]
0
0
Boras, Sweden
Query!
Country [40]
0
0
Sweden
Query!
State/province [40]
0
0
Lund
Query!
Country [41]
0
0
Sweden
Query!
State/province [41]
0
0
Stockholm
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Eli Lilly and Company
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02674386
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02674386
Download to PDF