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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
Secondary ID [1] 0 0
2013-002549-12
Secondary ID [2] 0 0
A4091064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1
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 - 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.
Timepoint [2] 0 0
Week 24
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline up to Week 24
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline up to Week 24
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline up to Week 24
Primary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline, Week 24
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline, Week 24
Primary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline, Week 24
Primary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline, Week 24
Primary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline, Week 24
Primary outcome [11] 0 0
Number of Participants Who Used Concomitant Analgesic Medications
Timepoint [11] 0 0
Baseline up to Week 24

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None.

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Germany
State/province [22] 0 0
Bad Doberan
Country [23] 0 0
Hungary
State/province [23] 0 0
Szekszard
Country [24] 0 0
Italy
State/province [24] 0 0
Rome
Country [25] 0 0
Japan
State/province [25] 0 0
Hyogo
Country [26] 0 0
Japan
State/province [26] 0 0
Miyagi
Country [27] 0 0
Japan
State/province [27] 0 0
Nagano
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Lithuania
State/province [29] 0 0
Kaunas
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland
Country [31] 0 0
New Zealand
State/province [31] 0 0
Tauranga
Country [32] 0 0
Portugal
State/province [32] 0 0
Viana DO Castelo
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Saint-Petersburg
Country [34] 0 0
Serbia
State/province [34] 0 0
Belgrade
Country [35] 0 0
Slovakia
State/province [35] 0 0
Dolny Kubin
Country [36] 0 0
Slovakia
State/province [36] 0 0
Pruske
Country [37] 0 0
Spain
State/province [37] 0 0
Alicante
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Sweden
State/province [39] 0 0
Boras, Sweden
Country [40] 0 0
Sweden
State/province [40] 0 0
Lund
Country [41] 0 0
Sweden
State/province [41] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT02674386
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications