Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT02674386
Collaborator
Eli Lilly and Company (Industry)
154
79
1
34.7
1.9
0.1
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.
Study Design
Study Type:
Interventional
Actual Enrollment
:
154 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
Actual Study Start Date
:
Aug 23, 2016
Actual Primary Completion Date
:
Jul 15, 2019
Actual Study Completion Date
:
Jul 15, 2019
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Surgeon's Assessment of Procedural Difficulty [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline up to Week 24]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Alabama Research | Birmingham | Alabama | United States | 35209 |
| 2 | Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | United States | 35235 |
| 3 | Alabama Orthopaedic Surgeons | Birmingham | Alabama | United States | 35235 |
| 4 | Cahaba Research Inc. | Birmingham | Alabama | United States | 35242 |
| 5 | Noble Clinical Research | Tucson | Arizona | United States | 85704 |
| 6 | Baptist Health Center for Clinical Research | Little Rock | Arkansas | United States | 72205 |
| 7 | Advanced Research Center, Inc. | Anaheim | California | United States | 92805 |
| 8 | Hope Clinical Research | Canoga Park | California | United States | 91303 |
| 9 | Marvel Clinical Research, LLC | Huntington Beach | California | United States | 92647 |
| 10 | Advances in Medicine | Palm Desert | California | United States | 92260 |
| 11 | Clinical Trials Research | Sacramento | California | United States | 95821 |
| 12 | California Research Foundation | San Diego | California | United States | 92123 |
| 13 | CITrials | Santa Ana | California | United States | 92705 |
| 14 | Stamford Therapeutics Consortium | Stamford | Connecticut | United States | 06905 |
| 15 | JEM Research Institute | Atlantis | Florida | United States | 33462 |
| 16 | Orthopedic Research Institute | Boynton Beach | Florida | United States | 33472 |
| 17 | Orthopaedic Associates of West Florida | Clearwater | Florida | United States | 33756 |
| 18 | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | United States | 32256 |
| 19 | Clintex Research Group | Miami | Florida | United States | 33135 |
| 20 | Renstar Medical Research | Ocala | Florida | United States | 34470 |
| 21 | American Family Medical | Ocala | Florida | United States | 34471 |
| 22 | Sunshine Research Center | Opa-locka | Florida | United States | 33054 |
| 23 | Gulfcoast Research Institute, LLC | Sarasota | Florida | United States | 34232-6028 |
| 24 | Kennedy White Orthopaedic Center | Sarasota | Florida | United States | 34232 |
| 25 | Stedman Clinical Trials | Tampa | Florida | United States | 33613 |
| 26 | Masters of Clinical Research, Inc. | Augusta | Georgia | United States | 30909 |
| 27 | North Georgia Clinical Research | Woodstock | Georgia | United States | 30189 |
| 28 | North Georgia Internal Medicine | Woodstock | Georgia | United States | 30189 |
| 29 | Injury Care Research | Boise | Idaho | United States | 83713 |
| 30 | Chicago Clinical Research Institute, Inc. | Chicago | Illinois | United States | 60607 |
| 31 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 32 | Professional Research Network of Kansas, LLC | Wichita | Kansas | United States | 67205-1138 |
| 33 | Best Clinical Trials, LLC | New Orleans | Louisiana | United States | 70115 |
| 34 | George Stanley Walker, MD | New Orleans | Louisiana | United States | 70115 |
| 35 | Great Lakes Research Group, Incorporated | Bay City | Michigan | United States | 48706 |
| 36 | Orthopaedic Associates of Michigan, PC | Grand Rapids | Michigan | United States | 49525 |
| 37 | Physician Research Collaboration, LLC | Lincoln | Nebraska | United States | 68516 |
| 38 | Drug Trials America | Hartsdale | New York | United States | 10530 |
| 39 | Remington-Davis, Incorporated | Columbus | Ohio | United States | 43215 |
| 40 | Optimed Research LTD | Columbus | Ohio | United States | 43235 |
| 41 | AC Clinical Research | Tiffin | Ohio | United States | 44883 |
| 42 | Founders Research Corporation | Philadelphia | Pennsylvania | United States | 19114 |
| 43 | Abigail R. Neiman, MD, PA | Houston | Texas | United States | 77024 |
| 44 | Advances In Health | Houston | Texas | United States | 77030 |
| 45 | Mercury Clinical Research, Inc. | Houston | Texas | United States | 77036 |
| 46 | BI Research Center | Houston | Texas | United States | 77084 |
| 47 | ClinRx Research | Richardson | Texas | United States | 75080 |
| 48 | DCT - Stone Oak, LLC dba Discovery Clinical Trials | San Antonio | Texas | United States | 78258 |
| 49 | Mercury Clinical Research | Webster | Texas | United States | 77598 |
| 50 | Spectrum Medical, Inc. | Danville | Virginia | United States | 24541 |
| 51 | Northwest Clinical Research Center | Bellevue | Washington | United States | 98007 |
| 52 | CMAX Clinical Research Pty Ltd | Adelaide | South Australia | Australia | 5000 |
| 53 | Dawson Road Medical Centre | Guelph | Ontario | Canada | N1H 1B1 |
| 54 | Rebecca Medical Associates | Oakville | Ontario | Canada | L6K 1J6 |
| 55 | Recherche Clinique Sigma inc | Quebec | Canada | G1G 3Y8 | |
| 56 | Centre de recherche Saint-Louis | Quebec | Canada | G1W 4R4 | |
| 57 | Rheumazentrum Prof. Dr. med Gunther Neeck | Bad Doberan | Germany | 18209 | |
| 58 | Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly | Szekszard | Hungary | 7100 | |
| 59 | Azienda Ospedaliero-Universitaria E Policlinico Umberto I | Rome | Italy | 00161 | |
| 60 | Omuro Orthopedic Clinic | Himeji | Hyogo | Japan | 670-0976 |
| 61 | Nakajo Orthopedic Clinic | Sendai | Miyagi | Japan | 983-0862 |
| 62 | Marunouchi Hospital | Matsumoto | Nagano | Japan | 390-8601 |
| 63 | National Hospital Organization Osaka Minami Medical Center | Kawachinagano | Osaka | Japan | 586-8521 |
| 64 | Osaka University Hospital | Suita | Osaka | Japan | 565-0871 |
| 65 | Saules seimos medicinos centras | Kaunas | Lithuania | LT-49449 | |
| 66 | South Pacific Clinical Trials | Auckland | New Zealand | 0610 | |
| 67 | Star Unit, North Shore Hospital, Waitemata District Health Board | Auckland | New Zealand | 0622 | |
| 68 | Southern Clinical Trials- Waitemata Ltd | Auckland | New Zealand | 0626 | |
| 69 | Clinical Horizons NZ Ltd | Tauranga | New Zealand | 3112 | |
| 70 | Hospital Conde de Bertiandos | Ponte de Lima | Viana DO Castelo | Portugal | 4990-041 |
| 71 | Medical Technologies Ltd. | Saint-Petersburg | Russian Federation | 191025 | |
| 72 | Institute of Rheumatology | Belgrade | Serbia | 11000 | |
| 73 | Kompan, s.r.o. | Dolny Kubin | Slovakia | 02601 | |
| 74 | Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o. | Pruske | Slovakia | 018 52 | |
| 75 | Instituto de Ciencias Medicas | Alicante | Spain | 03004 | |
| 76 | Hospital del Mar | Barcelona | Spain | 08003 | |
| 77 | Ladulaas Kliniska Studier | Boras, Sweden | Sweden | SE-506 30 | |
| 78 | ProbarE I Lund AB | Lund | Sweden | 222 22 | |
| 79 | ProbarE i Stockholm AB | Stockholm | Sweden | 111 37 |
Sponsors and Collaborators
- Pfizer
- Eli Lilly and Company
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02674386
Other Study ID Numbers:
- A4091064
- 2013-002549-12
- TJR FOLLOW-UP
First Posted:
Feb 4, 2016
Last Update Posted:
Jul 30, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This study included participants from studies A4091056 (NCT02697773), A4091057 (NCT02709486) and A4091058 (NCT02528188) who had undergone a total joint replacement (TJR) surgery of knee, hip, or shoulder. During this study, if participant underwent an additional TJR surgery, then data for that additional TJR surgery was also assessed. |
|---|---|
| Pre-assignment Detail | Pre-specified intent of this study was to compare results regardless of treatment group/doses in parent studies and also to report data for overall (combined participants from all parent studies). |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab subcutaneous (SC) injection of 2.5 milligram (mg) or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. |
| Period Title: Overall Study | |||
| STARTED | 20 | 117 | 17 |
| Safety Analysis Set | 20 | 113 | 17 |
| COMPLETED | 20 | 107 | 16 |
| NOT COMPLETED | 0 | 10 | 1 |
Baseline Characteristics
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Total of all reporting groups |
| Overall Participants | 20 | 113 | 17 | 150 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
65.26
(8.77)
|
64.57
(8.18)
|
62.94
(9.13)
|
64.47
(8.33)
|
| Sex/Gender, Customized (Count of Participants) | ||||
| Male |
6
30%
|
50
44.2%
|
4
23.5%
|
60
40%
|
| Female |
13
65%
|
62
54.9%
|
13
76.5%
|
88
58.7%
|
| Unspecified |
1
5%
|
1
0.9%
|
0
0%
|
2
1.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
1
5%
|
3
2.7%
|
3
17.6%
|
7
4.7%
|
| Not Hispanic or Latino |
18
90%
|
109
96.5%
|
14
82.4%
|
141
94%
|
| Unknown or Not Reported |
1
5%
|
1
0.9%
|
0
0%
|
2
1.3%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
10%
|
6
5.3%
|
0
0%
|
8
5.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
6
5.3%
|
3
17.6%
|
9
6%
|
| White |
17
85%
|
100
88.5%
|
14
82.4%
|
131
87.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
5%
|
1
0.9%
|
0
0%
|
2
1.3%
|
Outcome Measures
| Title | Number of Participants With Surgeon's Assessment of Procedural Difficulty |
|---|---|
| Description | 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. |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set analyzed. Here, 'Overall number of participants analyzed (N)' = only those participants who had data available for this outcome measure (OM). 'Number analyzed (n)' = participants evaluable for this OM at specified categories. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 17 | 92 | 13 | 122 |
| Uneventful |
9
45%
|
49
43.4%
|
8
47.1%
|
66
44%
|
| Minor Complications |
0
0%
|
2
1.8%
|
0
0%
|
2
1.3%
|
| Major Complications |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Uneventful |
8
40%
|
37
32.7%
|
4
23.5%
|
49
32.7%
|
| Minor Complications |
0
0%
|
4
3.5%
|
0
0%
|
4
2.7%
|
| Major Complications |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Uneventful |
0
0%
|
0
0%
|
1
5.9%
|
1
0.7%
|
| Minor Complications |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Major Complications |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 |
|---|---|
| Description | 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. |
| Time Frame | Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 19 | 99 | 13 | 131 |
| Satisfied |
9
45%
|
53
46.9%
|
5
29.4%
|
67
44.7%
|
| Dissatisfied |
0
0%
|
5
4.4%
|
1
5.9%
|
6
4%
|
| Satisfied |
9
45%
|
52
46%
|
5
29.4%
|
66
44%
|
| Dissatisfied |
0
0%
|
6
5.3%
|
1
5.9%
|
7
4.7%
|
| Satisfied |
9
45%
|
48
42.5%
|
5
29.4%
|
62
41.3%
|
| Dissatisfied |
0
0%
|
10
8.8%
|
1
5.9%
|
11
7.3%
|
| Satisfied |
9
45%
|
50
44.2%
|
5
29.4%
|
64
42.7%
|
| Dissatisfied |
0
0%
|
8
7.1%
|
1
5.9%
|
9
6%
|
| Satisfied |
9
45%
|
40
35.4%
|
6
35.3%
|
55
36.7%
|
| Dissatisfied |
1
5%
|
1
0.9%
|
0
0%
|
2
1.3%
|
| Satisfied |
9
45%
|
41
36.3%
|
6
35.3%
|
56
37.3%
|
| Dissatisfied |
1
5%
|
0
0%
|
0
0%
|
1
0.7%
|
| Satisfied |
9
45%
|
41
36.3%
|
6
35.3%
|
56
37.3%
|
| Dissatisfied |
1
5%
|
0
0%
|
0
0%
|
1
0.7%
|
| Satisfied |
9
45%
|
40
35.4%
|
6
35.3%
|
55
36.7%
|
| Dissatisfied |
1
5%
|
1
0.9%
|
0
0%
|
2
1.3%
|
| Satisfied |
0
0%
|
0
0%
|
1
5.9%
|
1
0.7%
|
| Dissatisfied |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Satisfied |
0
0%
|
0
0%
|
1
5.9%
|
1
0.7%
|
| Dissatisfied |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Satisfied |
0
0%
|
0
0%
|
1
5.9%
|
1
0.7%
|
| Dissatisfied |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Satisfied |
0
0%
|
0
0%
|
1
5.9%
|
1
0.7%
|
| Dissatisfied |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Post-Surgical Complications Upto Week 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 20 | 113 | 17 | 150 |
| Knee |
0
0%
|
1
0.9%
|
0
0%
|
1
0.7%
|
| Hip |
0
0%
|
5
4.4%
|
0
0%
|
5
3.3%
|
| Shoulder |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 20 | 113 | 17 | 150 |
| Knee |
0
0%
|
4
3.5%
|
0
0%
|
4
2.7%
|
| Hip |
0
0%
|
5
4.4%
|
1
5.9%
|
6
4%
|
| Shoulder |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 20 | 113 | 17 | 150 |
| Knee |
10
50%
|
55
48.7%
|
7
41.2%
|
72
48%
|
| Hip |
9
45%
|
33
29.2%
|
3
17.6%
|
45
30%
|
| Shoulder |
0
0%
|
0
0%
|
1
5.9%
|
1
0.7%
|
| Title | Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'n' = participants evaluable for this OM at specified categories. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 20 | 113 | 17 | 150 |
| Measure total joint replacements | 20 | 113 | 17 | 150 |
| Baseline: Knee |
6.00
(2.31)
|
6.86
(2.14)
|
6.80
(2.20)
|
6.76
(2.16)
|
| Baseline: Hip |
6.10
(2.13)
|
6.81
(2.27)
|
5.86
(3.44)
|
6.60
(2.38)
|
| Change at Week 24: Knee |
-4.56
(1.24)
|
-5.32
(2.63)
|
-5.43
(2.51)
|
-5.24
(2.49)
|
| Change at Week 24: Hip |
-5.20
(2.30)
|
-5.67
(2.37)
|
-5.00
(4.10)
|
-5.52
(2.53)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 20 | 113 | 15 | 148 |
| Measure total joint replacements | 20 | 113 | 15 | 148 |
| Baseline: Knee |
4.66
(3.05)
|
5.62
(2.33)
|
6.11
(2.31)
|
5.56
(2.41)
|
| Baseline: Hip |
4.80
(2.61)
|
5.97
(2.46)
|
6.13
(1.98)
|
5.80
(2.45)
|
| Change at Week 24: Knee |
-3.13
(1.74)
|
-4.50
(2.43)
|
-4.54
(3.15)
|
-4.34
(2.44)
|
| Change at Week 24: Hip |
-4.34
(2.52)
|
-4.92
(2.62)
|
-5.92
(2.40)
|
-4.91
(2.57)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 20 | 113 | 15 | 148 |
| Measure total joint replacements | 20 | 113 | 15 | 148 |
| Baseline: Knee |
4.80
(2.78)
|
5.75
(2.52)
|
6.44
(2.58)
|
5.71
(2.55)
|
| Baseline: Hip |
4.70
(2.75)
|
5.96
(2.69)
|
5.25
(3.50)
|
5.69
(2.77)
|
| Change at Week 24: Knee |
-1.78
(1.52)
|
-4.13
(2.58)
|
-3.43
(3.13)
|
-3.79
(2.62)
|
| Change at Week 24: Hip |
-4.00
(2.66)
|
-4.48
(2.87)
|
-3.80
(3.70)
|
-4.33
(2.86)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 20 | 113 | 15 | 148 |
| Measure total joint replacements | 20 | 113 | 15 | 148 |
| Baseline: Knee |
4.83
(2.99)
|
5.82
(2.11)
|
6.63
(1.98)
|
5.79
(2.23)
|
| Baseline: Hip |
5.56
(2.21)
|
6.50
(2.22)
|
6.86
(1.48)
|
6.38
(2.17)
|
| Change at Week 24: Knee |
-2.69
(1.51)
|
-4.42
(2.19)
|
-4.59
(2.90)
|
-4.24
(2.24)
|
| Change at Week 24: Hip |
-4.64
(2.13)
|
-5.05
(2.44)
|
-5.95
(1.84)
|
-5.06
(2.33)
|
| Title | Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Enrolled participants who received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had qualifying shoulder replacement. "N"=those participants who had data available for this OM, hence data for Placebo and Tanezumab reporting groups were not collected as no participants were evaluable for this OM. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 0 | 0 | 1 | 1 |
| Measure total joint replacements | 0 | 0 | 1 | 1 |
| Baseline |
89.88
|
89.88
|
||
| Change at Week 24 |
-89.88
|
-89.88
|
| Title | Number of Participants Who Used Concomitant Analgesic Medications |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: all enrolled participants of this study who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. |
| Arm/Group Title | Placebo | Tanezumab Combined | NSAID | All Participants |
|---|---|---|---|---|
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. |
| Measure Participants | 20 | 113 | 17 | 150 |
| Count of Participants [Participants] |
18
90%
|
100
88.5%
|
15
88.2%
|
133
88.7%
|
Adverse Events
| Time Frame | Baseline up to Week 24 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined. | |||||||||||||
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 2.5/5 mg | Tanezumab 5 mg | Tanezumab Combined | NSAID | All Participants | |||||||
| Arm/Group Description | Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery. | Participants who received tanezumab 2.5 mg SC injection in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received tanezumab 2.5/5 mg SC injection in study A4091056 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received tanezumab 5 mg SC injection in studies A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery. | All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery. | |||||||
All Cause Mortality |
||||||||||||||
| Placebo | Tanezumab 2.5 mg | Tanezumab 2.5/5 mg | Tanezumab 5 mg | Tanezumab Combined | NSAID | All Participants | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 0/53 (0%) | 0/113 (0%) | 0/17 (0%) | 0/150 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| Placebo | Tanezumab 2.5 mg | Tanezumab 2.5/5 mg | Tanezumab 5 mg | Tanezumab Combined | NSAID | All Participants | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 5/52 (9.6%) | 3/8 (37.5%) | 7/53 (13.2%) | 15/113 (13.3%) | 2/17 (11.8%) | 17/150 (11.3%) | |||||||
| Cardiac disorders | ||||||||||||||
| Coronary artery occlusion | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Colitis ischaemic | 0/20 (0%) | 0/52 (0%) | 1/8 (12.5%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Diarrhoea | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Enteritis | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Hiatus hernia | 0/20 (0%) | 0/52 (0%) | 1/8 (12.5%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Cholecystitis | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 1/53 (1.9%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Infections and infestations | ||||||||||||||
| Device related infection | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 1/53 (1.9%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Gastroenteritis viral | 0/20 (0%) | 0/52 (0%) | 1/8 (12.5%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Pneumonia | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 1/53 (1.9%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Post procedural infection | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Periprosthetic fracture | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Tendon rupture | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 1/53 (1.9%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Osteoarthritis | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 2/53 (3.8%) | 3/113 (2.7%) | 2/17 (11.8%) | 5/150 (3.3%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Transitional cell carcinoma | 0/20 (0%) | 0/52 (0%) | 1/8 (12.5%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Nervous system disorders | ||||||||||||||
| Parkinson's disease | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 1/53 (1.9%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Product Issues | ||||||||||||||
| Device dislocation | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 1/53 (1.9%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Hallucination | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 1/53 (1.9%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Vascular disorders | ||||||||||||||
| Deep vein thrombosis | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
| Haematoma | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 0/53 (0%) | 1/113 (0.9%) | 0/17 (0%) | 1/150 (0.7%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Placebo | Tanezumab 2.5 mg | Tanezumab 2.5/5 mg | Tanezumab 5 mg | Tanezumab Combined | NSAID | All Participants | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 9/52 (17.3%) | 3/8 (37.5%) | 9/53 (17%) | 21/113 (18.6%) | 4/17 (23.5%) | 25/150 (16.7%) | |||||||
| Cardiac disorders | ||||||||||||||
| Atrioventricular block second degree | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 0/53 (0%) | 0/113 (0%) | 1/17 (5.9%) | 1/150 (0.7%) | |||||||
| Coronary artery stenosis | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 0/53 (0%) | 0/113 (0%) | 1/17 (5.9%) | 1/150 (0.7%) | |||||||
| General disorders | ||||||||||||||
| Chest pain | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 0/53 (0%) | 0/113 (0%) | 1/17 (5.9%) | 1/150 (0.7%) | |||||||
| Peripheral swelling | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 0/53 (0%) | 0/113 (0%) | 1/17 (5.9%) | 1/150 (0.7%) | |||||||
| Immune system disorders | ||||||||||||||
| Drug hypersensitivity | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 0/53 (0%) | 0/113 (0%) | 1/17 (5.9%) | 1/150 (0.7%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Procedural pain | 0/20 (0%) | 3/52 (5.8%) | 0/8 (0%) | 6/53 (11.3%) | 9/113 (8%) | 0/17 (0%) | 9/150 (6%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 0/20 (0%) | 0/52 (0%) | 1/8 (12.5%) | 2/53 (3.8%) | 3/113 (2.7%) | 0/17 (0%) | 3/150 (2%) | |||||||
| Joint swelling | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 0/53 (0%) | 1/113 (0.9%) | 1/17 (5.9%) | 2/150 (1.3%) | |||||||
| Osteoarthritis | 0/20 (0%) | 3/52 (5.8%) | 0/8 (0%) | 0/53 (0%) | 3/113 (2.7%) | 0/17 (0%) | 3/150 (2%) | |||||||
| Spinal osteoarthritis | 0/20 (0%) | 1/52 (1.9%) | 1/8 (12.5%) | 0/53 (0%) | 2/113 (1.8%) | 0/17 (0%) | 2/150 (1.3%) | |||||||
| Tendonitis | 0/20 (0%) | 1/52 (1.9%) | 0/8 (0%) | 0/53 (0%) | 1/113 (0.9%) | 1/17 (5.9%) | 2/150 (1.3%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Urinary retention | 0/20 (0%) | 0/52 (0%) | 1/8 (12.5%) | 1/53 (1.9%) | 2/113 (1.8%) | 0/17 (0%) | 2/150 (1.3%) | |||||||
| Vascular disorders | ||||||||||||||
| Deep vein thrombosis | 0/20 (0%) | 0/52 (0%) | 0/8 (0%) | 0/53 (0%) | 0/113 (0%) | 1/17 (5.9%) | 1/150 (0.7%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02674386
Other Study ID Numbers:
- A4091064
- 2013-002549-12
- TJR FOLLOW-UP
First Posted:
Feb 4, 2016
Last Update Posted:
Jul 30, 2020
Last Verified:
Jul 1, 2020